Trial | NCT00384995  Report issue

Title

Bicarbonate v Saline to Prevent Contrast Nephropathy
Phase 4 Study of Bicarbonate Versus Saline Infusion Therapy to Prevent Contrast Induced Nephropathy (CAN-IT PREVENT Protocol)

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    61
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.
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.
Study Started
Dec 31
2006
Primary Completion
Jul 31
2009
Study Completion
Jul 31
2009
Last Update
Dec 01
2010
Estimate

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

Saline solution

  • Other names: Sodium Chloride

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

Bicarbonate solution

  • Other names: Sodium Bicarbonate

Bicarbonate Experimental

Bicarbonate solution infusion

Saline Active Comparator

Standard volume expansion

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
No Results Posted