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Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate

NCT00472563 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2008-05-06

No results posted yet for this study

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.

Conditions

  • Acute Kidney Failure

Interventions

DRUG

Bicarbinate 150 mEq/L

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

Sponsors & Collaborators

  • Universidad de Antioquia

    lead OTHER

Principal Investigators

  • Wilmar A Maya Salazar, MD · Universidad de Antioquia

  • Julián M Aristizábal, MD · Universidad de Antioquia

  • Oscar M Santos, MD · Universidad de Antioquia

  • John F Nieto, MD · Universidad de Antioquia

  • Liliana Jaramillo, MD · Universidad de Antioquia

  • Jorge I García, MD · Universidad de Antioquia

  • Fabian A Jaimes, MD · Universidad de Antioquia

  • Alvaro García, MD · Universidad de Antioquia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00472563 on ClinicalTrials.gov