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

Comparing Sodium Bicarbonate Plus Isotonic Normal Saline Versus Isotonic Normal Saline Alone to Prevent Contrast-Induced Nephropathy in Patients Undergoing Coronary Angiography: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Contrast Induced Nephropathy
• Intervention / Treatment: Drug: normal saline 0.9%; Drug: Sodium Bicarbonate plus normal saline 0.9%

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.

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.

• Study Type: Interventional
• Enrollment (Actual): 265
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 1411713138
    • Tehran Heart Center

Participation Criteria

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 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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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%	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.)
Active Comparator: 2; 1075 cc fluid made by adding 75 cc of sodium bicarbonate 8.4% to 1000 cc of 154 mEq/ L NaCl 0.9%.	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.

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.	at 48 hours

Secondary 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 5 days after exposure to a contrast agent compared to baseline serum creatinine values.	at day 5
Days in hospital within the month post contrast	whithin the month post contrast
Urine PH after initial bolus	whithin 6 hours after initial bolus
development of contrast induced nephropathy defined as at least 25% decrease in glomerular filtration rate (GFR) at 48 hours.	at 48 hours
development of contrast induced nephropathy defined as at least 25% decrease in glomerular filtration rate (GFR) at day 5.	at day 5

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences
• Collaborators: Tehran Heart Center
• Investigators: 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: Ahmad Iaminisharif, M.D., Tehran Heart Center; Principal Investigator: Saeid Sadeghian, 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: Sirus Darabian, 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 Director: Ali Vasheghani-Farahani, M.D., Tehran University of Medical Sciences, Tehran Heart Center; Principal Investigator: Mohammad Ali Mansournia, MD, Tehran University of Medical Sciences; Principal Investigator: Mohammad Ali Boroumand, MD, Tehran Heart Center; Principal Investigator: Farah Aiatollahzade Esfehani, BSc,RN, Tehran Heart Center

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 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): September 5, 2008
• Last Update Submitted That Met QC Criteria: September 4, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: complications; prevention; kidney; angiography; contrast media
• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases
• Other Study ID Numbers: 85-02-30-3595(1)