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

November 23, 2008 updated by: Tehran University of Medical Sciences

The Evaluation of the Effect of Sodium Bicarbonate Solution in Decreasing the Incidence of Contrast Induced Nephropathy (CIN) in Patients With Pulmonary Edema,Severe Heart Failure or Uncontrolled Hypertension

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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%
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.
Active Comparator: 2
1075 cc fluid made by adding 75 cc of sodium bicarbonate solution 8.4% to 1000 cc of NaCl 0.45%.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
development of contrast induced nephropathy defined as an absolute (> or = 0.5 mg/dl) or relative increase (> or = 25%) in serum creatinine at 48 hours after exposure to a contrast agent compared to baseline serum creatinine values.
Time Frame: at 48 hours
at 48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
an absolute (> or = 0.5 mg/dl) or relative increase(> or= 25% ) in serum creatinine at day 5 after exposure to a contrast agent.
Time Frame: at day 5
at day 5
Urine PH after initial bolus
Time Frame: within 6 hours after initial bolus
within 6 hours after initial bolus
development of contrast induced nephropathy defined as 25% decrease in glomerular filtration rate (GFR) at 48 hours.
Time Frame: at 48 hours
at 48 hours
development of contrast induced nephropathy defined as 25% decrease in glomerular filtration rate (GFR)on day 5 .
Time Frame: on day 5 post contrast
on day 5 post contrast

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Collaborators

Tehran Heart Center

Investigators

  • Study Director: Ali Farahani Vasheghani, M.D., Tehran University of Medical Sciences, Tehran Heart Center
  • Principal Investigator: Ebrahim Kassaian, M.D., Tehran Heart Center
  • Principal Investigator: Akbar Fotuhi, M.D., Tehran Heart Center
  • Principal Investigator: Mohammad Reza Khatami, M.D., Tehran Heart Center
  • Principal Investigator: Mojtaba Salarifar, M.D., Tehran Heart Center
  • Principal Investigator: Ebrahim Nematipur, M.D., Tehran Heart Center
  • Principal Investigator: Ahmad Iaminisharif, M.D., Tehran Heart Center
  • Principal Investigator: Saeid Sadeghian, M.D., Tehran Heart Center
  • Principal Investigator: Ali mohammad Hajzeinali, M.D., Tehran Heart Center
  • Principal Investigator: Mohammad Alidoosti, M.D., Tehran Heart Center
  • Principal Investigator: Hamidreza Purhosseini,, M.D., Tehran Heart Center
  • Principal Investigator: Ali Kazemisaeid, M.D., Tehran Heart Center
  • Principal Investigator: Gholamreza Davoodi, M.D., Tehran Heart Center
  • Principal Investigator: Alireza Amirzadegan, M.D., Tehran Heart Center
  • Principal Investigator: Abbas Soleimani, M.D., Tehran Heart Center
  • Principal Investigator: Sirus Darabian, M.D., Tehran Heart Center
  • Principal Investigator: Kianush Hossein, M.D., Tehran Heart Center
  • Principal Investigator: Gelareh Sadigh, M.D., Tehran University of Medical Sciences
  • Principal Investigator: Amir Hossein Razavi, M.D., Tehran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

August 8, 2007

First Submitted That Met QC Criteria

August 8, 2007

First Posted (Estimate)

August 9, 2007

Study Record Updates

Last Update Posted (Estimate)

November 26, 2008

Last Update Submitted That Met QC Criteria

November 23, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 85-02-30-3595(2)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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