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

Saleh 2017.

Study characteristics
Methods
  • Study design: parallel RCT

  • Study duration: December 2011 to November 2016

  • Duration of follow‐up: 45 days

Participants
  • Country: Egypt, Saudi Arabia

  • Setting: multicentre (3 sites)

  • Patients on regular HD using long‐term catheters with suspected CRBSI

  • Number: catheter exchange group (339) catheter removal group (339)

  • Mean age ± SD (years): catheter exchange group (56.7 ± 9); catheter removal group (61.2 ± 10)

  • Sex (female): catheter exchange group/catheter removal group (207/239)

  • Diabetes: catheter exchange group/catheter removal group (237/236)

  • Hypertension: catheter exchange group/catheter removal group (288/278)

  • Coronary artery disease: catheter exchange group/catheter removal group (149/132)

  • Congestive heart failure: catheter exchange group/catheter removal group (27/34)

  • Exclusion criteria: septic shock (CRBSI + haemodynamic instability); metastatic infection; sources of infection other than CRBSI; without catheter replacement after 10 days (because of AVF maturation or persistent fever or death); negative catheter tip culture result

Interventions Catheter exchange group
  • Catheter replacement over a guidewire 2 or 3 days after initiating systemic antibiotic therapy


Catheter removal group
  • Catheter removal and new catheter insertion when negative blood cultures were obtained (approximately 3 to 7 days after the removal)

  • HD was performed through a short‐term femoral catheter after primary catheter removal


Both groups
  • Empiric systemic antibiotics (vancomycin and gentamicin) during dialysis through the catheter for 3 weeks (tailored according to culture if needed)

Outcomes
  • Catheter infection‐free survival time

  • Cure: asymptomatic for at least 45 days after completion of the antibiotic course in addition to negative blood culture

  • Treatment failure: any bacteraemia involving the original organism within 45 days after antibiotic completion in addition to clinical manifestation

  • Indetermined results: unrelated death, catheter removal for unrelated reason or infection with a different organism

Notes
  • Funding source: not reported

  • Contact with study authors: twice, no response received

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Prospective randomisation was conducted by sealed envelope randomisation service
Allocation concealment (selection bias) Low risk The randomisation service also provided allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes High risk It was impossible to blind the personnel and patients
Blinding of outcome assessment (detection bias)
All outcomes Low risk The published trial protocol reported single masking (care provider)
Incomplete outcome data (attrition bias)
All outcomes High risk Primary outcomes were not fully reported
Selective reporting (reporting bias) High risk The trial protocol (NCT03054714) was published retrospectively. Additionally, did not mention excluded or withdrawn patients, deaths, treatment failures and absolute numbers for cure
Other bias High risk Among the exclusion criteria were patients in whom the catheter was not replaced within 10 days because of death. This exclusion criterion could be concealing an important adverse event for this specific intervention

AVF ‐ arteriovenous fistula; CRB ‐ catheter‐related bacteraemia; CRBSI ‐ catheter‐related bloodstream infection; HD ‐ haemodialysis; RCT ‐ randomised controlled trial; SD ‐ standard deviation; TPA ‐ tissue plasminogen activator