Overview

Bicarbonate v Saline to Prevent Contrast Nephropathy

Status:
Terminated
Trial end date:
2009-07-01
Target enrollment:
0
Participant gender:
All
Summary
Slowing of kidney function occurs in a minority of people given dye during angiography. The purpose of this study is to compare two different types of fluid given into a vein to reduce the risk of kidney injury: salt in water or baking soda in water.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Italian Society of Nephrology
Collaborators:
European Commission
Memorial University of Newfoundland
Criteria
Inclusion Criteria:

- Booked for cardiac or other non-renal arteriography

- Pre-existing reduced kidney function: Serum Creatinine >= 1.3 & <= 4 mg/dl (female
gender) or >= 1.5 & <= 5 mg/dl (male gender)

- Age > 18 years

Exclusion Criteria:

- GFR MDRD estimate < 15 ml/min/m2

- End-stage renal disease already on dialysis

- Known current Acute Kidney Failure with serum creatinine rise of > 0.5 mg/dl within 24
hours

- Pulmonary edema - current or within 48 hours

- Clinically relevant ascites, edema or other fluid overload

- Uncontrolled hypertension (> 165 mmHg systolic, or > 105 mmHg diastolic)

- Hemodynamically unstable patient requiring IV nitroglycerine, or IV fluid or inotropes
for blood pressure support

- Emergency (unplanned) angiography

- IV contrast procedure

- Exposure to iodinated radiocontrast within 3 days prior to study

- Prior anaphylactoid reaction to contrast

- Planned administration of N-acetylcysteine

- Planned administration of dopamine, fenoldopam or mannitol

- Current pregnancy