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

This study has been completed.
Sponsor:
Collaborator:
Tehran Heart Center
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00514150
First received: August 8, 2007
Last updated: September 4, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Contrast Induced Nephropathy
Drug: Sodium Bicarbonate plus normal saline 0.9%
Drug: normal saline 0.9%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

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. [ Time Frame: at 48 hours ] [ Designated as safety issue: Yes ]

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. [ Time Frame: at day 5 ] [ Designated as safety issue: Yes ]
  • Days in hospital within the month post contrast [ Time Frame: whithin the month post contrast ] [ Designated as safety issue: Yes ]
  • Urine PH after initial bolus [ Time Frame: whithin 6 hours after initial bolus ] [ Designated as safety issue: Yes ]
  • development of contrast induced nephropathy defined as at least 25% decrease in glomerular filtration rate (GFR) at 48 hours. [ Time Frame: at 48 hours ] [ Designated as safety issue: Yes ]
  • development of contrast induced nephropathy defined as at least 25% decrease in glomerular filtration rate (GFR) at day 5. [ Time Frame: at day 5 ] [ Designated as safety issue: Yes ]

Enrollment: 265
Study Start Date: August 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514150

Locations
Iran, Islamic Republic of
Tehran Heart Center
Tehran, Iran, Islamic Republic of, 1411713138
Sponsors and Collaborators
Tehran University of Medical Sciences
Tehran Heart Center
Investigators
Study Director: Ali Vasheghani-Farahani, 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: 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
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
  More Information

No publications provided

Responsible Party: Ali Vasheghani Farahani, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00514150     History of Changes
Other Study ID Numbers: 85-02-30-3595(1)
Study First Received: August 8, 2007
Last Updated: September 4, 2008
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
angiography
complications
contrast media
kidney
prevention

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 20, 2014