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. 2022 Apr 1;2022(4):CD013554. doi: 10.1002/14651858.CD013554.pub2

Khosroshahi 2015.

Study characteristics
Methods
  • Study design: parallel RCT

  • Study duration: May 2009 to May 2011

  • Duration of follow‐up: 3 weeks

Participants
  • Country: Iran

  • Setting: single centre

  • Patients with kidney failure and suspected CRBSI

  • Number of patients: treatment group (32); control group (32)

  • Mean age ± SD (years): treatment group (57.6 ± 14.6); control group (57.5 ± 16.8)

  • Sex (M/F): table report is unclear

  • Exclusion criteria: extra catheter source of infection; catheter removal due to AVF maturation; and any cause of death except catheter infection

Interventions Treatment group
  • Ethanol‐lock solution: 2 mL 60% ethanol + 1 mL heparin sodium 5000 UI/mL into both lines of the catheter at the end of each HD session


Control group
  • No lock solution


Both groups
  • Empiric systemic antibiotics (vancomycin alone or combined with a third‐generation cephalosporin) tailored after cultures, if needed

Outcomes
  • Successful eradication of infection: clinical improvement in signs and symptoms within 48 hours of initiating systemic antibiotics in addition to locking the catheter with ethanol

Notes
  • Funding source: Tabriz University of Medical Sciences, Iran

  • Contact with study authors: Reply on 4th of August 2020 ‐ Clarification regarding the allocation method but raw data unavailable

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Patients were randomly divided into two groups using the www.randomization.org website
Allocation concealment (selection bias) Low risk The randomisation list was provided to the HD centre nurses (data supplied via correspondence)
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Practitioners were blinded, but there was no mention of the blinding of patients
Blinding of outcome assessment (detection bias)
All outcomes Low risk The practitioner who evaluated the outcome was not aware of the patient groups and type of treatment
Incomplete outcome data (attrition bias)
All outcomes Low risk All participants completed the study, and there were no losses during the follow‐up
Selective reporting (reporting bias) High risk Trial registration (https://www.irct.ir/trial/2728) was completed retrospectively. Fever and chills, considered as primary consequences (observed at the beginning of the study and during each HD session) and culture results and catheter removal, considered secondary consequences, were not reported as planned
Other bias High risk The study population considered suspected CRBSI, which resulted of 45% unconfirmed cases (negative blood cultures). There is no mention of which group these negative cultures belonged to, which could significantly influence the results