title: Vasopressin in pediatric vasodilatory shock: a multicenter randomized controlled trial.
abstract: BACKGROUND
  Vasopressin has been proposed as a potent vasoactive agent in the treatment of vasodilatory shock in adults and children. The objective of this trial was to evaluate the efficacy and safety of vasopressin as an adjunctive agent in pediatric vasodilatory shock.
  
  
  METHODS
  In this multicenter, double-blind trial, children with vasodilatory shock were randomized to receive low-dose vasopressin (0.0005-0.002 U/kg/min) or placebo in addition to open-label vasoactive agents. Vasoactive infusions were titrated to clinical endpoints of adequate perfusion. The primary outcome was time to vasoactive-free hemodynamic stability. Secondary outcomes included mortality, organ-failure-free days, length of critical care unit stay, and adverse events.
  
  
  RESULTS
  Sixty-five of 69 children (94%) who were randomized received the study drug (33 vasopressin, 32 placebo) and were included in the analysis. There was no significant difference in the primary outcome between the vasopressin and placebo groups (49.7 vs. 47.1 hours; P = 0.85). There were 10 deaths (30%) in the vasopressin group and five (15.6%) in the placebo group (relative risk, 1.94; 95% confidence interval, 0.75-5.05; P = 0.24). There were no significant differences with respect to organ failure-free days (22 vs. 25.5 days; P = 0.11), ventilator-free days (16.5 23 days; P = 0.15), length of stay (8 vs. 8.5 days; P = 0.93), or adverse event rate ratios (12.0%; 95% confidence interval, -2.6 to 26.7; P = 0.15).
  
  
  CONCLUSIONS
  Low-dose vasopressin did not demonstrate any beneficial effects in this pediatric trial. Although not statistically significant, there was a concerning trend toward increased mortality. Clinical trial registered with www.controlled-trials.com (ISRCTN11597444).
authors.affiliation: Department of Pediatrics and Critical Care McMaster Children's Hospital, 1200 Main Street West, Room 3A78, Hamilton, ON, L8N 3Z5 Canada. choongk@mcmaster.ca
authors.forename: Karen
authors.initials: K
authors.lastname: Choong
authors.forename: Desmond
authors.initials: D
authors.lastname: Bohn
authors.forename: Douglas D
authors.initials: DD
authors.lastname: Fraser
authors.forename: Isabelle
authors.initials: I
authors.lastname: Gaboury
authors.forename: James S
authors.initials: JS
authors.lastname: Hutchison
authors.forename: Ari R
authors.initials: AR
authors.lastname: Joffe
authors.forename: Catherine
authors.initials: C
authors.lastname: Litalien
authors.forename: Kusum
authors.initials: K
authors.lastname: Menon
authors.forename: Patrick
authors.initials: P
authors.lastname: McNamara
authors.forename: Roxanne E
authors.initials: RE
authors.lastname: Ward
mesh_terms: D000293:Adolescent; D001127:Arginine Vasopressin / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D009102:Multiple Organ Failure / Q000517:prevention & control; D012769:Shock / Q000188:drug therapy*; D016019:Survival Analysis; D016896:Treatment Outcome; D014662:Vasoconstrictor Agents / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D014662:Vasoconstrictor Agents; D001127:Arginine Vasopressin