Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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:


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
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: 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

ClinicalTrials.gov processed this record on November 25, 2014