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. 2018 Apr 3;2018(4):CD010597. doi: 10.1002/14651858.CD010597.pub2

Bleyer 2005.

Methods

  • Study design: parallel RCT

  • Study duration: 1 August 1998 to 17 November 1999

  • Duration of follow‐up: to 31 December 2000
Participants

  • Setting: multicentre (4 centres)

  • Country: USA

  • Participants to remain in the hospital for more than 30 days or if they were expected it receive HD at one of four dialysis centres in the vicinity

  • Number (patients/catheters): treatment group (30/30); control group (30/30)

  • Mean age ± SD (years): treatment group (50.1 ± 19.6); control group (58.7 ± 13.5)

  • Sex (F): treatment group (36.7%); control group (48.2%)

  • Exclusion criteria: active catheter infection; active infection at any site within the previous 48 hours; known allergies to heparin, minocycline, or EDTA; serum calcium < 7.5 mg/dL with symptoms; previous enrolment in the study
Interventions Treatment group

  • Minocycline‐EDTA: minocycline (3 mg/mL); EDTA (30 mg/mL)


Control group

  • Heparin: 5000 U/mL
Outcomes

  • Catheter clotting

  • Catheter colonisation

  • CRI
Notes

  • Funding source: not reported

  • "One of the investigators at the study site (RJS) is a co‐patent holder on the minocycline–EDTA flush solution being studied. Another author at a distant site (IIR) is the other patent holder. The study was blinded and the data analyses were done by AJB and GR to minimize any potential conflicts"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "The patients were randomised according to a block design, with each block consisting of four patients"; however method of randomisation not reported
Allocation concealment (selection bias) Low risk "Only the pharmacist who prepared and distributed the catheter solutions knew the randomizations code"
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double‐blind study. "Each solution was drawn up into a syringe, and each syringe was wrapped in orange plastic so that differences in color between the two solutions (minocycline–EDTA, orange; heparin, clear) could not be identified."
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes High risk Three losses in the control group were not considered in the analysis
Selective reporting (reporting bias) Low risk Describes the outcome according to protocol
Other bias Unclear risk Funding source not reported; 2 authors were patent holders for treatment solution