drugset

drugset / Trial / NCT00201214

Citrulline for Children Undergoing Cardiopulmonary Bypass Surgery

NCT00201214 ↗

Phase 1/2 Completed 26 enrolled Vanderbilt University National Heart, Lung, and Blood Institute (NHLBI) · collab

NaSingle-groupOpen-labelTreatment

Summary

This study will determine the pharmacokinetics and safety of intravenous citrulline given to children undergoing cardiopulmonary bypass for the correction of congenital heart defects.

Timeline

Start: 2003-12
Primary completion: 2006-01
Completion: 2009-12

Publications

Results Barr FE, Tirona RG, Taylor MB, Rice G, Arnold J, Cunningham G, Smith HA, Campbell A, Canter JA, Christian KG, Drinkwater DC, Scholl F, Kavanaugh-McHugh A, Summar ML. Pharmacokinetics and safety of intravenously administered citrulline in children undergoing congenital heart surgery: potential therapy for postoperative pulmonary hypertension. J Thorac Cardiovasc Surg. 2007 Aug;134(2):319-26. doi: 10.1016/j.jtcvs.2007.02.043.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	L-citrulline	Other / unclassified	9 mg/kg	Intravenous
Subject	L-citrulline	Other / unclassified	50 mg/kg	Intravenous
Subject	L-citrulline	Other / unclassified	100 mg/kg	Intravenous
Subject	L-citrulline	Other / unclassified	150 mg/kg	Intravenous

Indications