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

NCT ID: NCT00514150

Last Updated: 2008-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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Radio Contrast Induced Nephropathy (RCIN) remains a well recognized complication in patients undergoing diagnostic or interventional procedures requiring radiographic contrast agents and is the third leading cause of acquired acute renal failure in hospitalized patients. Strategies for the prevention of radiocontrast nephropathy have focused on countering vasoconstriction (pre-hydration, fenoldopam, and theophylline), enhancing flow through the nephron (diuretics), or protection against oxygen-free-radical injury (urinary alkalinization and N-acetylcysteine).

Among all prophylactic measures that have been proposed, adequate preprocedural and postprocedural hydration has demonstrated effectiveness in the prevention of radiocontrast nephropathy. Thus, it remains the most frequently applied measure in clinical practice.

A Recent study in May 2004 have shown benefit in administering Sodium Bicarbonate over normal saline as a prophylaxy.Since alkalizing renal tubular fluid with bicarbonate may reduce injury.

Comparisons: IV 154 mEq/L solution of NaCl 0.9% OR IV 154 mEq/ L sodium bicarbonate solved in 154 mEq/ L NaCl 0.9%. 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.

Conditions

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Contrast Induced Nephropathy

Keywords

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angiography complications contrast media kidney prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

1075 cc of 154 mEq/L solution of NaCl 0.9% , prepared by adding 75 cc of 154 mEq/L NaCl 0.9 % to 1000 cc of 154 mEq/L NaCl 0.9%

Group Type ACTIVE_COMPARATOR

normal saline 0.9%

Intervention Type DRUG

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.)

2

1075 cc fluid made by adding 75 cc of sodium bicarbonate 8.4% to 1000 cc of 154 mEq/ L NaCl 0.9%.

Group Type ACTIVE_COMPARATOR

Sodium Bicarbonate plus normal saline 0.9%

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* individuals aged 18 years or older with stable serum creatinine levels of at least 1.5 mg/dl , who were scheduled to undergo diagnostic or therapeutic coronary artery angiography during the next 24 hours of hospitalization and were available until 5 days after the procedure for serum creatinine measurements.

Exclusion Criteria

* serum creatinine levels of more than 8 mg/dl
* previous history of dialysis
* eGFR \< 20
* emergency catheterization
* recent exposure to radiographic contrast agents (within previous two days of the study)
* radiocontrast agent dosage needed more than 300 cc during the procedure
* allergy to radiocontrast agent
* pregnancy
* administration of dopamine, mannitol , fenoldopam or N-Acetyl Cystein during the intended time of study
* need for continuous hydration therapy (e.g. sepsis )
* history of Multiple myeloma , Pulmonary edema , Uncontrolled hypertension (treated systolic blood pressure more than 160 mmHg, or diastolic blood pressure more than 100mmHg.) ,Severe heart failure (EF \< 30% or NYHA 3-4).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran Heart Center

OTHER

Sponsor Role collaborator

Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Tehran University of Medical Sciences

Principal Investigators

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Ali Vasheghani-Farahani, M.D.

Role: STUDY_DIRECTOR

Tehran University of Medical Sciences, Tehran Heart Center

Ebrahim Kassaian, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tehran Heart Center

Akbar Fotuhi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tehran Heart Center

Mohammad Reza Khatami, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tehran Heart Center

Mojtaba Salarifar, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tehran Heart Center

Ahmad Iaminisharif, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tehran Heart Center

Saeid Sadeghian, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tehran Heart Center

Gholamreza Davoodi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tehran Heart Center

Alireza Amirzadegan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tehran Heart Center

Sirus Darabian, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tehran Heart Center

Gelareh Sadigh, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Amir Hossein Razavi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Mohammad Ali Mansournia, MD

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Mohammad Ali Boroumand, MD

Role: PRINCIPAL_INVESTIGATOR

Tehran Heart Center

Farah Aiatollahzade Esfehani, BSc,RN

Role: PRINCIPAL_INVESTIGATOR

Tehran Heart Center

Locations

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Tehran Heart Center

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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85-02-30-3595(1)

Identifier Type: -

Identifier Source: org_study_id