Preventing Contrast Nephropathy With Sodium Bicarbonate in Patients With Pulmonary Edema,Heart Failure,Uncontrolled HTN

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.But most studies have excluded patients with history of pulmonary edema, severe heart failure(NYHA 3-4), uncontrolled hypertension or ejection fraction less than 30%. Therefore the aim of this study is to evaluate the efficacy of sodium bicarbonate solved in half saline compared with infusion of half saline in prevention of RCIN in these groups of patients.

Conditions

• Contrast Induced Nephropathy

Interventions

DRUG

Sodium Bicarbonate

IV solution of NaCl 0.45% (Arm 1) or IV 75 cc of sodium bicarbonate 8.4% solved in 1 liter of NaCl 0.45% (Arm 2) . Each fluid is 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 Farahani Vasheghani, 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

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

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

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

• Ali mohammad Hajzeinali, M.D. · Tehran Heart Center

• Mohammad Alidoosti, M.D. · Tehran Heart Center

• Hamidreza Purhosseini,, M.D. · Tehran Heart Center

• Ali Kazemisaeid, M.D. · Tehran Heart Center

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

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

• Abbas Soleimani, M.D. · Tehran Heart Center

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

• Kianush Hossein, M.D. · Tehran Heart Center

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

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

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

2008-07-31

Completion

2008-07-31

Countries

• Iran

Study Locations