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Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate — PROMEC  

Acute Kidney Failure Clinical Trial

Official title:
Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate

Clinical Trial Summary

Deterioration of kidney renal function occurs in a minority of people due to contrast-required procedures. The purpose of this study is to compare two different interventions to reduce the risk of kidney injury after contrast medium exposition.

We will perform a randomized clinical trial following a modification of a previously published protocol (Merten et al.JAMA 2004;291(19):2328-34). Patients will be randomly assigned to one of two groups of treatment. Group A will receive 1 cc/kg/hour of 0.9% saline infusion starting 12 hours before and continuing 12 hours after the procedure. Group B will receive 3 cc/kg of sodium bicarbonate solution for one hour prior to procedure, then drip rate will be decreased to 1 cc/kg/hour until 6 hours post procedure.

Clinical Trial Description

We will perform a randomized clinical trial following a modification of a previously published protocol (Merten et al.JAMA 2004;291(19):2328-34). Patients will be randomly assigned to one of two groups of treatment. Group A will receive 1 cc/kg/hour of 0.9% saline infusion starting 12 hours before and continuing 12 hours after the procedure. Group B will receive 3 cc/kg of sodium bicarbonate solution for one hour prior to procedure, then drip rate will be decreased to 1 cc/kg/hour until 6 hours post procedure.

Phase 2/3 study Study Type: Interventional Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study.

Subjects: Consecutive samples of all inpatients who meet the inclusion criteria

Primary outcomes: Development of contrast induced nephropathy, defined as an increase in serum creatinine of 25% or more within 48 h after administration of contrast.

Secondary outcomes: change in serum bicarbonate; change in serum potassium; change in serum creatinine.

Expected total enrollment: 212

Allocation Assignment: Patients who meet inclusion criteria and agree to participate in the study will be assigned by a random number table to saline or bicarbonate, using closed envelopes and stratifying according to history of diabetes and type of procedure (cardiac catheterism or others).

Condition: Contrast Induced Nephropathy

Intervention: 75 cc of sodium bicarbonate (8.4%) mixed in 425 cc of D5W

Gender: both Age: 18+ years of age Recruitment Status: participants are currently being recruited

Facility location:

Universidad de Antioquia, Internal Medicine Department; Hospital Universitario San Vicente de Paul. Medellin, Colombia. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00472563
Study type Interventional
Source Universidad de Antioquia
Contact
Status Completed
Phase Phase 2/Phase 3
Start date May 2007
Completion date February 2008
View Details
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