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Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection

Primary Purpose

Emergent Coronary Procedure

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Sodium bicarbonate
Sodium Chloride
Sponsored by
Osaka General Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emergent Coronary Procedure focused on measuring Patients undergoing an emergent coronary procedure

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Osaka General Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sodium bicarbonate

Sodium chloride

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 16, 2008
Last Updated
July 12, 2010
Sponsor
Osaka General Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00700375
Brief Title
Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection
Official Title
Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection in Patients Undergoing an Emergent Coronary Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Osaka General Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergent Coronary Procedure
Keywords
Patients undergoing an emergent coronary procedure

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sodium bicarbonate
Arm Type
Experimental
Arm Title
Sodium chloride
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sodium bicarbonate
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride
Intervention Description
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 Measure Information:
Title
Occurrence of Contrast-induced Nephropathy
Description
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.
Time Frame
after procedure and 1,2-3day after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takahisa Yamada, directorate
Organizational Affiliation
OsakaGeneralMedicalCenter
Official's Role
Study Chair
Facility Information:
Facility Name
Osaka General Medical Center
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan

12. IPD Sharing Statement

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Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection

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