PROVOCATION Trial - PROphylactic intraVenOus Hydration for Contrast Agent Toxicity PreventION

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

258

Participants

Timeline

Start Date

June 30, 2005

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2009

Conditions
Kidney Failure, Acute
Interventions
DRUG

NaCl 0.9% i.v. or NaBic 1.4% i.v. or NaBic 1.4% i.v. + NaBic p.o. (Nephrotrans®)

"control group: preventive hydration with 154mEq/l saline at 1ml/kg per hour of 12 hours prior and after the procedure.~7h-sodium bicarbonate: before contrast 3ml/kg NaHCO3 166mEq/l for one hour, followed by NaHCO3 166mEq/l (1ml/kg per hour until 6h after contrast).~short-term sodium bicarbonate: NaHCO3 166mEq/l (3ml/kg) as a bolus 20 minutes before contrast; ingestion of Nephrotrans® (500mg NaHCO3/capsule: 1 capsule/10kg) with 1-2 dl non-sparkling mineral water at the start of the infusion. Ingestion of non-sparkling mineral water in the first 6 hours after contrast."

Trial Locations (3)

4031

University Hospital of Basel, Basel

4100

Kantonsspital Liestal - Universitätskliniken, Liestal

20138

Centro Cardiologico Monzino, Milan

All Listed Sponsors
collaborator

Swiss National Science Foundation

OTHER

lead

University Hospital, Basel, Switzerland

OTHER

NCT00130598 - PROVOCATION Trial - PROphylactic intraVenOus Hydration for Contrast Agent Toxicity PreventION | Biotech Hunter | Biotech Hunter