Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection

NCT ID: NCT00700375

Last Updated: 2010-07-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-03-31

Brief Summary

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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

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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.

Conditions

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Emergent Coronary Procedure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Sodium bicarbonate

Group Type EXPERIMENTAL

Sodium bicarbonate

Intervention Type DRUG

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

Sodium chloride

Group Type EXPERIMENTAL

Sodium Chloride

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Osaka General Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Osaka General Medical Center

Principal Investigators

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Takahisa Yamada, directorate

Role: STUDY_CHAIR

OsakaGeneralMedicalCenter

Locations

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Osaka General Medical Center

Osaka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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SBECP

Identifier Type: -

Identifier Source: org_study_id

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