Bicarbonate v Saline to Prevent Contrast Nephropathy

Italian Society of Nephrology

Status and phase

Terminated

Phase 4

Conditions

Contrast Media

Kidney Failure, Acute

Treatments

Drug: 1/6 M (166 mEq/L) IV Sodium Bicarbonate

Drug: 0.9% (154 mEq/L) IV Sodium Chloride

Study type

Interventional

Funder types

Other

Identifiers

NCT00384995

PR021676

Details and patient eligibility

About

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.

Full 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 fluids is recommended to reduce the risk of contrast nephropathy. However, data to support specific recommendations are lacking and the optimal fluid regimen remains unclear.

It has been hypothesized that alkalinization of tubular fluid might be beneficial by reducing pH dependent free radical levels. A recent trial found a lower frequency of creatinine rise > 25% within two days of contrast with a 7 hour infusion of isotonic sodium bicarbonate than with saline infusion (Merten GJ, JAMA 2004). However, it remains to be proven that bicarbonate is superior as this trial has a number of methodological flaws.

Comparison: IV 1/6 M sodium bicarbonate OR IV 0.9% saline, each isotonic fluid given at the same rate of sodium administration (3.25 ml/Kg over 1 hour pre-contrast, followed by 1.1 ml/Kg/hr for 6 hours for bicarbonate; 3.5 ml/Kg over 1 hour pre-contrast, followed by 1.2 ml/Kg/hr for 6 hours for saline). Total infusion time 7 hours (for both). Maximum rate of fluid permitted is that for a body weight of 110 Kg. Intra-vascular iso- or low-osmolality contrast in the minimal dose needed to complete the required imaging.

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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