PROVOCATION Trial - PROphylactic intraVenOus Hydration for Contrast Agent Toxicity PreventION

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Contrast nephropathy (CN) remains a common complication of radiographic procedures and an important cause of hospital-acquired acute renal failure. Only hydration with saline is uniformly accepted and used in clinical practice as a cornerstone for the prevention of CN. But the optimal preventive strategy for CN is not known. Sodium bicarbonate might be even more effective than hydration with sodium chloride for prophylaxis of CN. Therefore the aim of the study is to evaluate the efficacy of two regimens of sodium bicarbonate compared with a prolonged infusion of sodium chloride in the prevention of CN.

Primary endpoint: Decrease in glomerular filtration rate (GFR) within 48 hours.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Collaborator: Swiss National Science Foundation

Criteria

Inclusion Criteria:

• All patients admitted with renal dysfunction (baseline serum creatinine level above the upper limit of normal of the serum creatinine [>93umol/l for women and >117umol/l for men] or GFR <60ml/min [GFR calculated using the abbreviated MDRD study equation]) scheduled to undergo an intraarterial or intravenous radiographic contrast procedure within the next 24 hours.

Exclusion Criteria:

• Age <18 years

• Preexisting dialysis

• Allergy to radiographic contrast

• Pregnancy (women < 50 years: pregnancy test required)

• Severe heart failure (New York Heart Association [NYHA] III-IV)

• N-acetylcysteine
• Clinically vulnerable condition requiring continuous fluid therapy e.g. severe sepsis