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

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

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-07-31

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.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.

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 .

Most studies have excluded patients with history of pulmonary edema, severe heart failure(NYHA 3-4), uncontrolled hypertension or ejection fraction less than 30% and no specific protocol is tested for this group of patients. This study focuses on preventing RCIN in this specific group of patients .

Comparisons:1075 cc NaCl 0.45% or 75 cc of sodium bicarbonate 8.4% solved in one liter of NaCl 0.45%. 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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Contrast Nephropathy Sodium Bicarbonate 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 77 mEq/L solution of NaCl 0.45% , prepared by adding 75 cc of 77 mEq/L NaCl 0.45 % to 1000 cc of 77 mEq/L NaCl 0.45%

Group Type ACTIVE_COMPARATOR

Sodium Bicarbonate

Intervention Type DRUG

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.

2

1075 cc fluid made by adding 75 cc of sodium bicarbonate solution 8.4% to 1000 cc of NaCl 0.45%.

Group Type ACTIVE_COMPARATOR

Sodium Bicarbonate

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* individuals aged 18 years or older with serum creatinine levels of at least 1.5 mg/dl , who were scheduled to undergo diagnostic or therapeutic coronary artery angiography.
* Patients with a history of Pulmonary edema or
* Patients with severe Heart Failure ( NYHA 3-4) or
* Patients with ejection fraction of less than 30% on Echocardiography ( done in the previous month of admission) or
* Patients with uncontrolled hypertension (treated systolic blood pressure more than 160 mmHg, or diastolic blood pressure more than 100mmHg )

Exclusion Criteria

* serum creatinine levels of more than 8 mg/dl
* previous history of dialysis
* GFR \< 20 ( as calculated with this formula: ((140-Age)(Weight(Kg)) / Serum Creatinine(mg/dl) ×72 ) , in females GFR was multiplied by 0.85 )
* emergency catheterization
* recent exposure to radiographic contrast agents (within previous two days of the study)
* radiocontrast agent dosage needed more than 300 gr 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Tehran University of Medical Sciences

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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(2)

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

1

Sodium Bicarbonate

2

Sodium Bicarbonate

Interventions

Sodium Bicarbonate

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Tehran Heart Center

Tehran University of Medical Sciences

Responsible Party

Principal Investigators

Ali Farahani Vasheghani, M.D.

Ebrahim Kassaian, M.D.

Akbar Fotuhi, M.D.

Mohammad Reza Khatami, M.D.

Mojtaba Salarifar, M.D.

Ebrahim Nematipur, M.D.

Ahmad Iaminisharif, M.D.

Saeid Sadeghian, M.D.

Ali mohammad Hajzeinali, M.D.

Mohammad Alidoosti, M.D.

Hamidreza Purhosseini,, M.D.

Ali Kazemisaeid, M.D.

Gholamreza Davoodi, M.D.

Alireza Amirzadegan, M.D.

Abbas Soleimani, M.D.

Sirus Darabian, M.D.

Kianush Hossein, M.D.

Gelareh Sadigh, M.D.

Amir Hossein Razavi, M.D.

Locations

Tehran Heart Center

Countries

Other Identifiers

85-02-30-3595(2)