Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection
1 other identifier
interventional
59
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2008
CompletedFirst Posted
Study publicly available on registry
June 18, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
July 9, 2010
CompletedJuly 20, 2010
March 1, 2010
1.7 years
June 16, 2008
March 23, 2010
July 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of Contrast-induced Nephropathy
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.
after procedure and 1,2-3day after procedure
Study Arms (2)
Sodium bicarbonate
EXPERIMENTALSodium chloride
EXPERIMENTALInterventions
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
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
Eligibility Criteria
You may qualify if:
- Patients undergoing an emergent coronary procedure(within 60 minutes from admission)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Osaka General Medical Center
Osaka, 558-8558, Japan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Single center trial
Results Point of Contact
- Title
- Prevention on Conrast-Induced Nephropathy With Bolus Injection of Sodium Bicarbonate
- Organization
- Osaka General Medical Center
Study Officials
- STUDY CHAIR
Takahisa Yamada, directorate
OsakaGeneralMedicalCenter
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 16, 2008
First Posted
June 18, 2008
Study Start
July 1, 2008
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
July 20, 2010
Results First Posted
July 9, 2010
Record last verified: 2010-03