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Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00700375
First Posted: June 18, 2008
Last Update Posted: July 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Osaka General Medical Center
  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
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

Resource links provided by NLM:


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 ]
    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
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

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

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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.
  Contacts and Locations
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
  More Information

Responsible Party: Hiromichi Ueda, Osaka General Medical Center
ClinicalTrials.gov Identifier: NCT00700375     History of Changes
Other Study ID Numbers: SBECP
First Submitted: June 16, 2008
First Posted: June 18, 2008
Results First Submitted: March 23, 2010
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