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Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection

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ClinicalTrials.gov Identifier: NCT00700375
Recruitment Status : Completed
First Posted : June 18, 2008
Results First Posted : July 9, 2010
Last Update Posted : July 20, 2010
Sponsor:
Information provided by:
Osaka General Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Emergent Coronary Procedure Drug: Sodium bicarbonate Drug: Sodium Chloride Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection in Patients Undergoing an Emergent Coronary Procedure
Study Start Date : July 2008
Primary Completion Date : March 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arm Intervention/treatment
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
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



Primary Outcome Measures :
  1. Occurrence of Contrast-induced Nephropathy [ Time Frame: after procedure and 1,2-3day after procedure ]
    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.



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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hiromichi Ueda, Osaka General Medical Center
ClinicalTrials.gov Identifier: NCT00700375     History of Changes
Other Study ID Numbers: SBECP
First Posted: June 18, 2008    Key Record Dates
Results First Posted: July 9, 2010
Last Update Posted: July 20, 2010
Last Verified: March 2010

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