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

Moran 2012.

Methods
  • Study design: parallel RCT

  • Study duration: September 2003 to May 2008

  • Duration of follow‐up: not reported

Participants
  • Setting: multicentre (16)

  • Country: USA

  • All adult participants with either newly placed or existing tunnelled cuffed catheters

  • Number (participants/catheters): Treatment group (155/155); control group (148/148)

  • Mean age ± SD (years): treatment group (63.4 ± 15.6); control group (62.8 ± 16.8)

  • Sex (% M/F): treatment group (49/51); control group (54.7/45.3)

  • Exclusion criteria: active exit‐site or tunnel infection or other systemic or localized infection that was unresponsive to antibiotic therapy and/or was life‐threatening; any infection associated with one or more positive blood culture results until 14 days after blood culture results had become negative and clinical resolution of the episode had occurred; known allergy to heparin or gentamicin; known IV drug use

Interventions Treatment group
  • Gentamicin: 320 µg/mL

  • sodium citrate: 4%


Control group
  • Heparin: 5000 U/mL

Outcomes
  • CRI

  • Thrombosis

Notes
  • Funding source: "This study was entirely funded by Satellite Healthcare, the study sponsor. Dr Moran, Ms Khababa, Ms Sun, Ms Doss, and Dr Schiller were employees of Satellite Healthcare at the time the study was conducted."

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "...randomly assigned 1:1 to treatment or control groups using a central randomization system with participants randomly assigned within centers in blocks of 2 and 4 to ensure an approximate balance in the number of participants in each group within each centre"
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All patient outcome data reported
Selective reporting (reporting bias) Low risk Describes the outcome according to protocol
Other bias High risk This study was entirely funded by Satellite Healthcare, the study sponsor. Most investigators were employees of Satellite Healthcare at the time the study was conducted