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. 2013 Sep 15;2013(9):CD003588. doi: 10.1002/14651858.CD003588.pub3

Gorbea 1984.

Methods Alternately allocated controlled clinical trial
Participants 123 adult patients in a surgical ICU who required IV therapy for the required period of time. Hospital, USA
Interventions Administration set changes at 24 or 48 hours
Outcomes
  • Infusate colonization

  • IR‐BSI

  • CR‐BSI

  • All‐cause BSI

Notes Exclusions: patients receiving PN through a central line. Confounders: The 24 hour group had a greater no. of catheters/participant and a greater proportion receiving antibiotics
 Central catheters: 38%
 PN: 0% (central), not stated for peripheral
 Loss to follow‐up: 22%
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Poor random sequence generation; easily predictable
Quote: "alternatively assigned"
Allocation concealment (selection bias) High risk Not feasible because of poor sequence generation
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Not discussed, not feasible because of research design
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not discussed, not feasible because of research design
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Outcome blinding possible but not discussed
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Attrition adequately described
157 enrolled, 34 dropouts (15 in 24 hours, 19 in 48 hours) because of early discharge or death
Selective reporting (reporting bias) Low risk No pre‐protocol
Other bias High risk Difference in baseline characteristics of concern
  • More CVCs (49 vs 30) in 24 hour group

  • More cultures for all outcomes completed in 24 hour group

  • 24 hour group significantly increased injections, increased antibiotics, increased length of ICU stay

  • 24 hour group required only 24 hour minimum stay in ICU (or they were excluded); 48 hour group had to stay in ICU 48 hours (or they were excluded)