Status:
TERMINATED
Bicarbonate v Saline to Prevent Contrast Nephropathy
Lead Sponsor:
Italian Society of Nephrology
Collaborating Sponsors:
European Commission
Memorial University of Newfoundland
Conditions:
Kidney Failure, Acute
Contrast Media
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 kid...
Detailed Description
A decline in kidney function after contrast is associated with prolonged hospital stay, adverse cardiac events, and higher mortality both in hospital and in the long term. Deliberate administration of...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00384995
Start Date
December 1 2006
End Date
July 1 2009
Last Update
December 1 2010
Active Locations (5)
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1
Spedali Civili di Brescia
Brescia, Italy, 25100
2
Ospedale Ferrarotto
Catania, Italy, 95100
3
P.O. Uboldo
Cernusco sul Naviglio, Italy, 20063
4
Azienda Istituti Ospitalieri di Cremona
Cremona, Italy, 26100