| Methods |
Study design: parallel RCT Study time frame: January 2007 to March 2010 Duration of follow‐up: 2 years |
| Participants |
Country: Turkey Setting: multi‐centre (10) -
Aged > 18 years on maintenance bicarbonate HD scheduled thrice weekly 12 h/week, achieved mean single pool Kt/V above 1.2; willingness to participate in the study with a written informed consent
Number: treatment group (391); control group (391) Mean age ± SD (years): treatment group (56.4 ± 13.0); control group (56.5 ± 14.9) Sex (F): treatment group (40.4%); control group (41.9%) Exclusion criteria: scheduled for living donor renal transplantation; serious life‐limiting co‐morbid situations, namely active malignancy, active infection, end‐stage cardiac, pulmonary, or hepatic disease; pregnancy or lactating; Current requirement for HD more than 3 times/week due to medical comorbidity; GFR > 10 mL/min/1.73 m2 as measured by the average of urea and CrCl obtained from a urine collection of at least 24 hours; use of temporary catheter; insufficient vascular access (blood flow rate < 250 mL/min); urine output > 250mL/d; mental incompetence |
| Interventions |
Treatment group
Post‐dilution on‐line HDF, 3 times/week, 4 hours; FX series high‐flux helixone membranes used; ONLINEplus integrated Fresenius 4008S machines Duration of each session: 240 minutes Blood flow rates: 250 to 400 mL/min Substitution volume > 15 L
Control group
|
| Outcomes |
Composite of overall mortality and new CV events to include MI, stroke, revascularization, and unstable angina pectoris requiring hospitalisation CV mortality Hospitalisation rate Intradialytic complications including hypotension and cramp Health‐related QoL, depression burden, cognitive function Required medications Changes in BP, left ventricular geometry, arterial stiffness, post‐dialysis body weight, upper mid‐arm circumference, HCT and related rHuEPO doses, the levels of phosphorus, albumin, lipid parameters, C‐reactive protein, and B2 microglobulin Postdialysis total body water determined by bioimpedance analysis |
| Notes |
Exclusions post randomisation but pre‐intervention: not stated Stop or end point/s: not stated Additional data requested from authors: method of randomisation; details regarding blinding, allocation concealment, supplementary data/results Funding: "Sponsors and Collaborator‐Fresenius Medical Care North America" |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not stated |
| Allocation concealment (selection bias) |
Unclear risk |
Not stated |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Open‐label |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Open label |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
20% loss to follow‐up plus imbalance in loss to follow‐up due to vascular access problems |
| Selective reporting (reporting bias) |
Low risk |
Study protocol available and all patient important outcomes were reported |
| Other bias |
High risk |
Commercial sponsorship of study |
