Effect of Sodium Bicarbonate Solution in Decreasing the Incidence of Contrast Induced Nephropathy (CIN)

Summary

Radio Contrast Induced Nephropathy (RCIN) remains a well recognized complication in patients undergoing diagnostic or interventional procedures requiring radiographic contrast agents. Recent studies have shown benefit in administering Sodium Bicarbonate over normal saline( the uniformly accepted prophylaxy) in preventing RCIN.Therefore the aim of the study is to evaluate the efficacy of sodium bicarbonate solved in normal saline compared with infusion of normal saline in prevention of RCIN.

Conditions

• Contrast Induced Nephropathy

Interventions

DRUG

Sodium Bicarbonate plus normal saline 0.9%

IV sodium bicarbonate 8.4% solved in 154 mEq/ L NaCl 0.9% (infused at the rate of 3 ml/kg/ hour one hour before the angiographic procedure, continuing at the rate of 1 ml/kg/ hour for 6 hours after the procedure. Maximum rate of fluid permitted is that for a body weight of 110 Kg.

DRUG

normal saline 0.9%

IV 154 mEq/L solution of NaCl 0.9% (infused at the rate of 3 ml/kg/ hour one hour before the angiographic procedure, continuing at the rate of 1 ml/kg/ hour for 6 hours after the procedure. Maximum rate of fluid permitted is that for a body weight of 110 Kg.)

Sponsors & Collaborators

• Tehran Heart Center

  collaborator OTHER

• Tehran University of Medical Sciences

  lead OTHER

Principal Investigators

• Ali Vasheghani-Farahani, M.D. · Tehran University of Medical Sciences, Tehran Heart Center

• Ebrahim Kassaian, M.D. · Tehran Heart Center

• Akbar Fotuhi, M.D. · Tehran Heart Center

• Mohammad Reza Khatami, M.D. · Tehran Heart Center

• Mojtaba Salarifar, M.D. · Tehran Heart Center

• Ahmad Iaminisharif, M.D. · Tehran Heart Center

• Saeid Sadeghian, M.D. · Tehran Heart Center

• Gholamreza Davoodi, M.D. · Tehran Heart Center

• Alireza Amirzadegan, M.D. · Tehran Heart Center

• Sirus Darabian, M.D. · Tehran Heart Center

• Gelareh Sadigh, M.D. · Tehran University of Medical Sciences

• Amir Hossein Razavi, M.D. · Tehran University of Medical Sciences

• Mohammad Ali Mansournia, MD · Tehran University of Medical Sciences

• Mohammad Ali Boroumand, MD · Tehran Heart Center

• Farah Aiatollahzade Esfehani, BSc,RN · Tehran Heart Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-08-31

Primary Completion

2008-06-30

Completion

2008-06-30

Countries

• Iran

Study Locations