PEDIATRICS Vol. 119 No. 1 January 2007, pp. e284-e291 (doi:10.1542/peds.2006-0529)
ARTICLE |
A Randomized, Controlled Trial of Heparin Versus Placebo Infusion to Prolong the Usability of Peripherally Placed Percutaneous Central Venous Catheters (PCVCs) in Neonates: The HIP (Heparin Infusion for PCVC) Study
a Departments of Pediatrics
h Medical Imaging, Mount Sinai Hospital, Toronto, Ontario, Canada
c Department of Pediatrics, Children's Hospital, Hamilton Health Sciences Corporation, Hamilton, Ontario, Canada
d Departments of Newborn and Developmental Pediatrics
i Medical Imaging, Sunnybrook and Women's College Health Sciences Center, Toronto, Ontario, Canada
e Division of Neonatology
f Department of Medical Imaging, Hospital for Sick Children, Toronto, Ontario, Canada
b Departments of Pediatrics
g Medical Imaging, University of Toronto, Toronto, Ontario, Canada
BACKGROUND. Mechanical and infectious complications shorten the effective duration of peripherally inserted central venous catheters. Heparin use to prevent such complications and prolong the usability of peripherally inserted central venous catheters is inconclusive.
OBJECTIVE. Our goal was to evaluate the effectiveness of heparin in prolonging the usability of peripherally inserted central venous catheters in neonates.
DESIGN/METHODS. We performed a multicenter, randomized, controlled trial of heparin infusion (0.5 U/kg per hour) versus placebo for peripherally inserted central venous catheters in neonates. The primary outcome was duration of catheter use. Secondary outcomes were occlusion, catheter-related sepsis, thrombosis, and adverse effects of heparin. To detect a 168-hour (1-week) difference in the duration of catheter use, 192 patients were needed. Kaplan-Meier and Cox regression analyses were performed.
RESULTS. A total of 201 neonates were enrolled (heparin group: n = 100; control group: n = 101). Baseline demographics were similar between the groups. Duration of catheter use was longer in the infants in the heparin versus the placebo group. Study center, gender, birth weight, and type and position of the catheter were not predictors of duration of catheter use. For those in the heparin versus the placebo group, the incidence of elective catheter removal (therapy completed) was 63% vs 42%, of occlusion was 6% vs 31%, of thrombosis was 20% vs 21%, and of catheter-related sepsis was 10% vs 6%, respectively. No adverse events were noted.
CONCLUSIONS. Heparin infusion prolonged the duration of peripherally inserted central venous catheter usability, which permitted a higher percentage of neonates to complete therapy without increasing adverse effects.
Key Words: infant-newborn central venous catheter thrombosis anticoagulant controlled clinical trial
Abbreviations: PCVCperipherally placed percutaneous central venous catheter TPNtotal parenteral nutrition HITheparin-induced thrombocytopenia CIconfidence interval
Accepted Apr 26, 2006.
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