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Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection

This study has been completed.
Sponsor:
Information provided by:
Osaka General Medical Center
ClinicalTrials.gov Identifier:
NCT00700375
First received: June 16, 2008
Last updated: July 12, 2010
Last verified: March 2010
History of Changes
  Purpose

This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.


Condition Intervention Phase
Emergent Coronary Procedure
 Drug: Sodium bicarbonate
Drug: Sodium Chloride
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection in Patients Undergoing an Emergent Coronary Procedure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Osaka General Medical Center:

Primary Outcome Measures:
  • Occurrence of Contrast-induced Nephropathy [ Time Frame: after procedure and 1,2-3day after procedure ] [ Designated as safety issue: No ]
    The primary endpoint was the occurrence of contrast-induced nephropathy, defined as an increase >0.5 mg/dl or >25% in serum Cr concentration within 2 days of the procedure compared to the baseline level.


Enrollment: 59
Study Start Date: July 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sodium bicarbonate Drug: Sodium bicarbonate
8.4%sodium bicarbonate 0.5ml/kg bolus injection before procedure and hydration with 154mEq/l sodium bicarbonate 1ml/kg/Hr for 6 hours after the procedure
Other Name: Sodium bicarbonate
Experimental: Sodium chloride Drug: Sodium Chloride
8.4%sodium bicarbonate 0.5ml/kg bolus injection before procedure and hydration with 154mEq/l sodium bicarbonate 1ml/kg/Hr for 6 hours after the procedure
Other Name: Sodium chloride

Detailed Description:

This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.The End point is development of contrast-induced nephropathy.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing an emergent coronary procedure(within 60 minutes from admission)

Exclusion Criteria:

  • On dialysis
  • Pregnancy
  • Past use of bicarbonate or N-Acetyl-Cystein in 48hr
  • Past exposure to contrast media in 48hr
  • Circulatory insufficiency with lactic acidosis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700375

Locations
Japan
Osaka General Medical Center
Osaka, Japan, 558-8558
Sponsors and Collaborators
Osaka General Medical Center
Investigators
Study Chair: Takahisa Yamada, directorate OsakaGeneralMedicalCenter
  More Information

No publications provided

Responsible Party: Hiromichi Ueda, Osaka General Medical Center
ClinicalTrials.gov Identifier: NCT00700375     History of Changes
Other Study ID Numbers: SBECP
Study First Received: June 16, 2008
Results First Received: March 23, 2010
Last Updated: July 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Osaka General Medical Center:
Patients undergoing an emergent coronary procedure

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013