search
Back to results

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

Primary Purpose

Contrast Induced Nephropathy

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Sodium Bicarbonate plus normal saline 0.9%
normal saline 0.9%
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contrast Induced Nephropathy focused on measuring angiography, complications, contrast media, kidney, prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Tehran Heart Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

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%

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Days in hospital within the month post contrast
Urine PH after initial bolus
development of contrast induced nephropathy defined as at least 25% decrease in glomerular filtration rate (GFR) at 48 hours.
development of contrast induced nephropathy defined as at least 25% decrease in glomerular filtration rate (GFR) at day 5.

Full Information

First Posted
August 8, 2007
Last Updated
September 4, 2008
Sponsor
Tehran University of Medical Sciences
Collaborators
Tehran Heart Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00514150
Brief Title
Effect of Sodium Bicarbonate Solution in Decreasing the Incidence of Contrast Induced Nephropathy (CIN)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tehran University of Medical Sciences
Collaborators
Tehran Heart Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Induced Nephropathy
Keywords
angiography, complications, contrast media, kidney, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
265 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
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%
Arm Title
2
Arm Type
Active Comparator
Arm Description
1075 cc fluid made by adding 75 cc of sodium bicarbonate 8.4% to 1000 cc of 154 mEq/ L NaCl 0.9%.
Intervention Type
Drug
Intervention Name(s)
Sodium Bicarbonate plus normal saline 0.9%
Intervention Description
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
Intervention Name(s)
normal saline 0.9%
Intervention Description
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.)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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.
Time Frame
at day 5
Title
Days in hospital within the month post contrast
Time Frame
whithin the month post contrast
Title
Urine PH after initial bolus
Time Frame
whithin 6 hours after initial bolus
Title
development of contrast induced nephropathy defined as at least 25% decrease in glomerular filtration rate (GFR) at 48 hours.
Time Frame
at 48 hours
Title
development of contrast induced nephropathy defined as at least 25% decrease in glomerular filtration rate (GFR) at day 5.
Time Frame
at day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Vasheghani-Farahani, M.D.
Organizational Affiliation
Tehran University of Medical Sciences, Tehran Heart Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ebrahim Kassaian, M.D.
Organizational Affiliation
Tehran Heart Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Akbar Fotuhi, M.D.
Organizational Affiliation
Tehran Heart Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Reza Khatami, M.D.
Organizational Affiliation
Tehran Heart Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mojtaba Salarifar, M.D.
Organizational Affiliation
Tehran Heart Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmad Iaminisharif, M.D.
Organizational Affiliation
Tehran Heart Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Saeid Sadeghian, M.D.
Organizational Affiliation
Tehran Heart Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gholamreza Davoodi, M.D.
Organizational Affiliation
Tehran Heart Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alireza Amirzadegan, M.D.
Organizational Affiliation
Tehran Heart Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sirus Darabian, M.D.
Organizational Affiliation
Tehran Heart Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gelareh Sadigh, M.D.
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amir Hossein Razavi, M.D.
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Ali Mansournia, MD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Ali Boroumand, MD
Organizational Affiliation
Tehran Heart Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Farah Aiatollahzade Esfehani, BSc,RN
Organizational Affiliation
Tehran Heart Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tehran Heart Center
City
Tehran
ZIP/Postal Code
1411713138
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs