Status:
COMPLETED
PROVOCATION Trial - PROphylactic intraVenOus Hydration for Contrast Agent Toxicity PreventION
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborating Sponsors:
Swiss National Science Foundation
Conditions:
Kidney Failure, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
Background: Contrast nephropathy (CN) remains a common complication of radiographic procedures and an important cause of hospital-acquired acute renal failure, which contributes to morbidity and morta...
Eligibility Criteria
Inclusion
- 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
- 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 \</= 24 hours before contrast
- Clinically vulnerable condition requiring continuous fluid therapy e.g. severe sepsis
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT00130598
Start Date
June 1 2005
End Date
December 1 2009
Last Update
March 5 2010
Active Locations (3)
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1
Centro Cardiologico Monzino
Milan, Italy, 20138
2
University Hospital of Basel
Basel, Basel, Switzerland, 4031
3
Kantonsspital Liestal - Universitätskliniken
Liestal, Switzerland, 4100