Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
This review aims to look at the benefits and harms of urgent‐start PD (defined as initiation of PD within 2 weeks of catheter insertion) compared to HD (defined as initiation of HD using a CVC) in adults and children with CKD requiring long‐term RRT.
Background
Description of the condition
People with chronic kidney disease (CKD) requiring long‐term renal replacement therapy (RRT) is a common and growing problem affecting over two million people worldwide (AIHW 2016; Couser 2011; Gilg 2016). Even though one of the main predictors of better patient survival is having an established dialysis access at the time of dialysis commencement (Pisoni 2009; Ravani 2013), a large proportion of patients commence treatment via a central venous catheter (CVC) (40% to 80%) (ANZDATA 2015; Moist 2014; Rao 2016; USRDS 2015). In part, this is due to many patients (20% to 30%) who present ‘late’ to a nephrology service that necessitates commencement of dialysis urgently or in unplanned manner (Foote 2014). In other cases, it could be the consequence of health system failure such as a lack of established responsive dialysis access programme with limited access to a surgical or interventional nephrology service. In this setting, most patients start haemodialysis (HD) via a CVC, which then places them at a heightened risk of infection, prolonged hospitalisation, mortality (Perl 2011) as well as future complications from central vascular stenosis (Shingarev 2012). A recent systematic review, that included a total of 586,337 patients, identified that the use of CVC led to the highest risk of death, fatal infections, and cardiovascular events, compared with other types of vascular access (Ravani 2013). Moreover, these patients are more likely to remain on facility‐based HD (Morton 2010) rather than to transition to home‐based dialysis program such as peritoneal dialysis (PD), which confers an initial survival advantage (Kumar 2014; Masterson 2008).
PD is a type of home‐based dialysis that uses the peritoneum in a person’s abdomen as the membrane through which fluid and dissolved substances are exchanged with the blood. PD solution is introduced through a PD catheter, which is placed in the lower abdomen permanently (Mehrotra 2016). PD has many benefits at the patient‐level, including initial survival advantage compared to HD, easier to master technique, better preservation of residual kidney function, better patient‐level satisfaction, and preservation of vascular access for future use (Tokgoz 2009). PD can also offer annual cost savings of up to 40% compared to facility HD (KHA 2012; KHA 2016). However, uptake of PD remains relatively low and only accounts for approximately 11% of the global dialysis population (Jain 2012). The decision‐making process which leads to undertake a home therapy is complex and can be influenced by social circumstances, education, and the capacity to undertake training (Machowska 2016). However, one of the contributors to limited growth in PD may relate to the reluctance to utilize PD as the dialysis modality of choice without permanent dialysis access, which is driven by the practice to delay treatment by at least two weeks from the time of PD catheter insertion to lower the risk of catheter‐related complications such as leaks (Dombros 2005; Figueiredo 2010). However, these practices are guided by recommendations based on weak level of evidence (Dombros 2005; Figueiredo 2010).
More recently, urgent‐start PD has been promoted as an alternative form of urgent, unplanned dialysis treatment, which is has been reported to be effective and potentially has fewer adverse consequences based on findings from observational studies (Casaretto 2012; Ghaffari 2012; Jo 2007; Koch 2012; Lobbedez 2008; See 2017).
Description of the intervention
Traditionally, new CKD patients who require dialysis urgently but without having a permanent functional dialysis access are subjected to undergo HD via central venous dialysis catheter. In order to avoid the CVC and its related complications, urgent‐start PD, has been introduced as an alternative form RRT for unplanned chronic kidney disease (CKD) patients who require dialysis urgently. Currently, there is no universally agreed definition regarding the duration between PD catheter insertion and commencement that qualifies as urgent‐start PD. The International Society for Peritoneal Dialysis (ISPD) recommends the use of PD catheters at least two weeks after its insertion (Figueiredo 2010). The duration between PD catheter insertion and commencement (Ranganathan 2017), fill volume and insertion technique may have an impact on outcomes observed following urgent‐start PD and therefore will be considered as part of subgroup analyses in the present review.
How the intervention might work
Urgent‐start PD is initiated with low fill volumes in the supine position using a cycler to minimize the risk of peri‐catheter leak. Treatment can be delivered in both inpatient and outpatient settings.
Why it is important to do this review
The vast majority of evidence relating to outcomes from urgent‐start PD has been generated from single‐centre observational studies with relatively small patient numbers (Casaretto 2012; Ghaffari 2012; Jo 2007; Koch 2012; Lobbedez 2008), which has resulted in ad hoc implementation rather than a ‘standard’ care across the world.
Objectives
This review aims to look at the benefits and harms of urgent‐start PD (defined as initiation of PD within 2 weeks of catheter insertion) compared to HD (defined as initiation of HD using a CVC) in adults and children with CKD requiring long‐term RRT.
Methods
Criteria for considering studies for this review
Types of studies
All randomised controlled trials (RCTs), quasi‐RCTs (RCTs in which allocation to treatment was obtained by alternation, use of alternate medical records, date of birth or other predictable methods), and non‐RCTs comparing urgent‐start PD to HD treatments via CVC.
Types of participants
Participants to be considered in this review are both adults and children with CKD, who require dialysis treatment without established dialysis access in place.
Inclusion criteria
Participants to be included in this review are both adults and children with CKD, who require dialysis treatment. Participants will have had a PD catheter inserted to undergo PD or a CVC for HD.
Exclusion criteria
The review will not include data obtained from patients with acute kidney injury.
Types of interventions
Studies comparing urgent‐start PD and HD via CVC will be included in this review.
Intervention: patients commenced on urgent‐start PD, defined as initiation of PD therapy within two weeks of catheter placement.
Comparator: patients commenced on urgent‐start HD, defined as initiation of HD therapy using a CVC (cuffed and uncuffed at commencement).
Types of outcome measures
Primary outcomes
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Catheter‐related infectious complications occurring within 30 days (early complication) and 90 days (late complication)
Bacteraemia (defined as blood culture positive for bacteria) after commencement of dialysis (proportion of patients developing bacteraemia)
Peritonitis as defined by the ISPD guidelines (Li 2010) after commencement of dialysis (proportion of patients developing peritonitis)
Exit site or tunnel tract infection as defined by the ISPD guidelines (Li 2010) after commencement of dialysis (proportion of patients developing exit site or tunnel tract infections)
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Catheter‐related non‐infectious complications occurring within 30 days (early complication) and 90 days (late complication)
Exit site bleeding requiring intervention (e.g. additional application of suture) after commencement of dialysis (proportion of patients developing exit site bleeding)
Catheter malfunction, defined as catheter flow problems requiring intervention (medical (e.g. urokinase) or surgical (e.g. catheter replacement)) or malposition after commencement of dialysis (proportion of patients developing catheter malfunction)
Catheter re‐adjustment, defined as catheter malfunction requiring intervention to re‐adjust or replace the catheter (proportion of patients requiring catheter re‐adjustment procedure)
Home dialysis (proportion of patients on home dialysis (e.g. PD or home HD)).
Secondary outcomes
Technique survival (number of patients remaining on the initial mode of RRT at the end of study)
All‐cause mortality
Hospitalisation (average days spent in hospital and episodes of hospitalisation)
Pain/discomfort related to dialysis therapy
Adverse effects
Quality of life
Cost of dialysis treatment
Search methods for identification of studies
Electronic searches
Randomised controlled trials
We will search the Cochrane Kidney and Transplant Specialised Register through contact with the Information Specialist using search terms relevant to this review. The Register contains studies identified from the following sources.
Monthly searches of the Cochrane Central Register of Controlled Trials (CENTRAL)
Weekly searches of MEDLINE OVID SP
Handsearching of kidney‐related journals and the proceedings of major kidney conferences
Searching of the current year of EMBASE OVID SP
Weekly current awareness alerts for selected kidney and transplant journals
Searches of the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.
Studies contained in the Register are identified through search strategies for CENTRAL, MEDLINE, and EMBASE based on the scope of Cochrane Kidney and Transplant. Details of these strategies, as well as a list of handsearched journals, conference proceedings and current awareness alerts, are available in the "Specialised Register" section of information about Cochrane Kidney and Transplant.
See Appendix 1 for search terms used in strategies for this review.
Non‐randomised controlled trials
MEDLINE (OVID) and EMBASE (OVID) will be searched with the same terms used for identifying RCTs.
Searching other resources
Reference lists of review articles, relevant studies and clinical practice guidelines.
Letters seeking information about unpublished or incomplete studies to investigators known to be involved in previous studies.
Data collection and analysis
Selection of studies
The search strategy described will be used to obtain titles and abstracts of studies that may be relevant to the review. The titles and abstracts will be screened independently by two authors, who will discard studies that are not applicable; however studies and reviews that might include relevant data or information on studies will be retained initially. Two authors will independently assess retrieved abstracts and, if necessary the full text, of these studies to determine which studies satisfy the inclusion criteria.
Data extraction and management
Data extraction will be carried out independently by two authors using standard data extraction forms. Studies reported in non‐English language journals will be translated before assessment. Where more than one publication of one study exists, reports will be grouped together and the publication with the most complete data will be used in the analyses. Where relevant outcomes are only published in earlier versions these data will be used. Any discrepancy between published versions will be highlighted.
Assessment of risk of bias in included studies
Randomised controlled trials
The following items will be independently assessed by two authors using the risk of bias assessment tool for RCTs (Higgins 2011) (see Appendix 2).
Was there adequate sequence generation (selection bias)?
Was allocation adequately concealed (selection bias)?
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Was knowledge of the allocated interventions adequately prevented during the study?
Participants and personnel (performance bias)
Outcome assessors (detection bias)
Were incomplete outcome data adequately addressed (attrition bias)?
Are reports of the study free of suggestion of selective outcome reporting (reporting bias)?
Was the study apparently free of other problems that could put it at a risk of bias?
Non‐randomised controlled trials
The Newcastle‐Ottawa Scale (NOS) (www.ohri.ca/programs/clinical_epidemiology/nosgen.pdf) for assessing quality of non‐randomised studies will be used.
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For case control studies the following items will be evaluated.
Selection (adequacy of definition, representativeness of the cases, selection of controls, definition of controls)
Comparability (comparability of cases and controls on the basis of the design or analysis)
Exposure (ascertainment of exposure, same method of ascertainment for cases and controls, non‐response rate).
-
For cohort studies the following items will be evaluated.
Selection (representativeness of the exposed cohort, selection of the non‐exposed cohort, ascertainment of exposure, demonstration that outcome of interest was not present at start of study)
Comparability (comparability of cohorts on the basis of the design or analysis)
Outcome (assessment of outcome, adequacy of follow‐up and duration of follow‐up).
Measures of treatment effect
For dichotomous outcomes (e.g. death, mechanical complications within one month of commencement of PD) results will be expressed as risk ratio (RR) with 95% confidence intervals (CI). Where continuous scales of measurement are used to assess the effects of treatment (e.g. duration of hospitalisation, duration of PD training), the mean difference (MD) will be used, or the standardised mean difference (SMD) if different scales have been used. Outcomes from RCTs and non‐RCTs will be reported separately.
Unit of analysis issues
If the review is to include cluster RCTs, the unit of analysis will be at the same level as the allocation, using a summary measurements from each cluster. All data will be collected and analysed according to the type of measure (e.g. hazard ratios, odds ratio).
Dealing with missing data
Any further information required from the original author will be requested by written correspondence (e.g. emailing the corresponding author) and any relevant information obtained in this manner will be included in the review. Evaluation of important numerical data such as screened, randomised patients as well as intention‐to‐treat, as‐treated and per‐protocol population will be carefully performed. Attrition rates, for example drop‐outs, losses to follow‐up and withdrawals will be investigated. Issues of missing data and imputation methods (for example, last‐observation‐carried‐forward) will be critically appraised (Higgins 2011).
Assessment of heterogeneity
We will first assess the heterogeneity by visual inspection of the forest plot. We will quantify statistical heterogeneity using the I2 statistic, which describes the percentage of total variation across studies that is due to heterogeneity rather than sampling error (Higgins 2003). A guide to the interpretation of I2 values will be as follows.
0% to 40%: might not be important
30% to 60%: may represent moderate heterogeneity
50% to 90%: may represent substantial heterogeneity
75% to 100%: considerable heterogeneity.
The importance of the observed value of I2 depends on the magnitude and direction of treatment effects and the strength of evidence for heterogeneity (e.g. P‐value from the Chi2 test, or a confidence interval for I2) (Higgins 2011).
Assessment of reporting biases
If possible, funnel plots will be used to assess for the potential existence of small study bias (Higgins 2011).
Data synthesis
Data will be pooled using the random‐effects model but the fixed‐effect model will also be used to ensure robustness of the model chosen and susceptibility to outliers.
Subgroup analysis and investigation of heterogeneity
Subgroup analysis will be used to explore possible sources of heterogeneity (e.g. participants, interventions and study quality including method of PD catheter insertion). Heterogeneity among participants could be related to age and renal pathology (e.g. paediatric versus adults). Heterogeneity in treatments could be related to prior agent(s) used and the agent, dose and duration of therapy (e.g. initial fill volume). Therefore, subgroup analysis will be conducted to evaluate the source of heterogeneity according to:
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Participants
Adult versus paediatric patients
Incident versus prevalent patients
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Setting
Single‐centre versus multi‐centre
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Study design
RCT versus non‐RCT
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Type of treatment utilised
According to initial fill volume
Days to PD commencement (e.g. within 24 hours versus 7 days)
Methodological quality
Adverse effects will be tabulated and assessed with descriptive techniques, as they are likely to be different for the various agents used. Where possible, the risk difference with 95% CI will be calculated for each adverse effect, either compared to no treatment or to another agent.
Sensitivity analysis
We will perform sensitivity analyses in order to explore the influence of the following factors on effect size.
Repeating the analysis excluding unpublished studies
Repeating the analysis taking account of risk of bias, as specified
Repeating the analysis excluding any very long or large studies to establish how much they dominate the results
Repeating the analysis excluding studies using the following filters: diagnostic criteria, language of publication, source of funding (industry versus other), and country.
'Summary of findings' tables
We will present the main results of the review in 'Summary of findings' tables. These tables present key information concerning the quality of the evidence, the magnitude of the effects of the interventions examined, and the sum of the available data for the main outcomes (Schünemann 2011a). The 'Summary of findings' tables also include an overall grading of the evidence related to each of the main outcomes using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach (GRADE 2008). The GRADE approach defines the quality of a body of evidence as the extent to which one can be confident that an estimate of effect or association is close to the true quantity of specific interest. The quality of a body of evidence involves consideration of within‐trial risk of bias (methodological quality), directness of evidence, heterogeneity, precision of effect estimates and risk of publication bias (Schünemann 2011b). We plan to present the following outcomes in the 'Summary of findings' tables.
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Catheter‐related infectious complications within 30 and 90 days of commencement of dialysis
Bacteraemia
Peritonitis
Exit site or tunnel infections
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Catheter‐related non‐infectious complications within 30 and 90 days of commencement
Exit site bleeding
Catheter malfunction
Catheter re‐adjustment
Technique survival
Home dialysis
All‐cause mortality
Duration of hospitalisation
Acknowledgements
The authors wish to thank Cochrane Kidney and Transplant for their support and advice in the development of this protocol.
Appendices
Appendix 1. Electronic search strategies
| Database | Search terms |
| CENTRAL |
|
| MEDLINE |
|
| EMBASE |
|
Appendix 2. Risk of bias assessment tool
| Potential source of bias | Assessment criteria |
|
Random sequence generation Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence |
Low risk of bias: Random number table; computer random number generator; coin tossing; shuffling cards or envelopes; throwing dice; drawing of lots; minimisation (minimisation may be implemented without a random element, and this is considered to be equivalent to being random). |
| High risk of bias: Sequence generated by odd or even date of birth; date (or day) of admission; sequence generated by hospital or clinic record number; allocation by judgement of the clinician; by preference of the participant; based on the results of a laboratory test or a series of tests; by availability of the intervention. | |
| Unclear: Insufficient information about the sequence generation process to permit judgement. | |
|
Allocation concealment Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment |
Low risk of bias: Randomisation method described that would not allow investigator/participant to know or influence intervention group before eligible participant entered in the study (e.g. central allocation, including telephone, web‐based, and pharmacy‐controlled, randomisation; sequentially numbered drug containers of identical appearance; sequentially numbered, opaque, sealed envelopes). |
| High risk of bias: Using an open random allocation schedule (e.g. a list of random numbers); assignment envelopes were used without appropriate safeguards (e.g. if envelopes were unsealed or non‐opaque or not sequentially numbered); alternation or rotation; date of birth; case record number; any other explicitly unconcealed procedure. | |
| Unclear: Randomisation stated but no information on method used is available. | |
|
Blinding of participants and personnel Performance bias due to knowledge of the allocated interventions by participants and personnel during the study |
Low risk of bias: No blinding or incomplete blinding, but the review authors judge that the outcome is not likely to be influenced by lack of blinding; blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken. |
| High risk of bias: No blinding or incomplete blinding, and the outcome is likely to be influenced by lack of blinding; blinding of key study participants and personnel attempted, but likely that the blinding could have been broken, and the outcome is likely to be influenced by lack of blinding. | |
| Unclear: Insufficient information to permit judgement | |
|
Blinding of outcome assessment Detection bias due to knowledge of the allocated interventions by outcome assessors. |
Low risk of bias: No blinding of outcome assessment, but the review authors judge that the outcome measurement is not likely to be influenced by lack of blinding; blinding of outcome assessment ensured, and unlikely that the blinding could have been broken. |
| High risk of bias: No blinding of outcome assessment, and the outcome measurement is likely to be influenced by lack of blinding; blinding of outcome assessment, but likely that the blinding could have been broken, and the outcome measurement is likely to be influenced by lack of blinding. | |
| Unclear: Insufficient information to permit judgement | |
|
Incomplete outcome data Attrition bias due to amount, nature or handling of incomplete outcome data. |
Low risk of bias: No missing outcome data; reasons for missing outcome data unlikely to be related to true outcome (for survival data, censoring unlikely to be introducing bias); missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups; for dichotomous outcome data, the proportion of missing outcomes compared with observed event risk not enough to have a clinically relevant impact on the intervention effect estimate; for continuous outcome data, plausible effect size (difference in means or standardised difference in means) among missing outcomes not enough to have a clinically relevant impact on observed effect size; missing data have been imputed using appropriate methods. |
| High risk of bias: Reason for missing outcome data likely to be related to true outcome, with either imbalance in numbers or reasons for missing data across intervention groups; for dichotomous outcome data, the proportion of missing outcomes compared with observed event risk enough to induce clinically relevant bias in intervention effect estimate; for continuous outcome data, plausible effect size (difference in means or standardized difference in means) among missing outcomes enough to induce clinically relevant bias in observed effect size; ‘as‐treated’ analysis done with substantial departure of the intervention received from that assigned at randomisation; potentially inappropriate application of simple imputation. | |
| Unclear: Insufficient information to permit judgement | |
|
Selective reporting Reporting bias due to selective outcome reporting |
Low risk of bias: The study protocol is available and all of the study’s pre‐specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre‐specified way; the study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre‐specified (convincing text of this nature may be uncommon). |
| High risk of bias: Not all of the study’s pre‐specified primary outcomes have been reported; one or more primary outcomes is reported using measurements, analysis methods or subsets of the data (e.g. sub‐scales) that were not pre‐specified; one or more reported primary outcomes were not pre‐specified (unless clear justification for their reporting is provided, such as an unexpected adverse effect); one or more outcomes of interest in the review are reported incompletely so that they cannot be entered in a meta‐analysis; the study report fails to include results for a key outcome that would be expected to have been reported for such a study. | |
| Unclear: Insufficient information to permit judgement | |
|
Other bias Bias due to problems not covered elsewhere in the table |
Low risk of bias: The study appears to be free of other sources of bias. |
| High risk of bias: Had a potential source of bias related to the specific study design used; stopped early due to some data‐dependent process (including a formal‐stopping rule); had extreme baseline imbalance; has been claimed to have been fraudulent; had some other problem. | |
| Unclear: Insufficient information to assess whether an important risk of bias exists; insufficient rationale or evidence that an identified problem will introduce bias. |
Contributions of authors
Draft the protocol: YC, HH, CH, JC, AT, DJ
Study selection: YC, HH
Extract data from studies: YC, HH
Enter data into RevMan: YC, HH
Carry out the analysis: YC, HH, JC, AT
Interpret the analysis: YC, HH, CH, JC, AT, DJ
Draft the final review: YC, HH, CH, JC, AT, DJ
Disagreement resolution: JC, DJ
Update the review: YC
Sources of support
Internal sources
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National Health and Medical Research Council, Australia.
DJ is supported by Practitioner Fellowship; YC is supported by Early Career Fellowship
External sources
No sources of support supplied
Declarations of interest
None known.
New
References
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