The Use of Sodium Bicarbonate in the Prevention of Contra... | NCT00494637

Studies
The Use of Sodium Bicarbonate in the Prevention of Contrast Induced Nephropathy

NCT00494637

Sponsor

Lenox Hill Hospital

Status

Terminated

Last Update Posted

Jan 28, 2009Estimated

Enrollment

468Estimated

Phase

Not Applicable

Conditions

Contrast Induced Nephropathy

Interventions

sodium bicarbonate

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not reaching recruitment and endpoint goals

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Dec 2008Actual

Completion Date

Jan 2009Actual

First Submitted Date

Jun 29, 2007

First Submission Date that Met QC Criteria

Jun 29, 2007

First Posted Date

Jul 2, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2009

Last Update Posted Date

Jan 28, 2009Estimated

Name	Class
GE Healthcare	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Preliminary studies have shown a benefit of sodium bicarbonate infusion in decreasing the risk of contrast induced nephropathy with coronary angiography. The investigators plan to randomize 478 patients (with serum creatinine 1.5 mg/dl or greater) undergoing coronary angiography to intravenous isotonic saline or intravenous isotonic sodium bicarbonate beginning one hour before the procedure and for four hours after. The primary endpoint is the development of contrast nephropathy within 48-72 hours after the procedure. Patients with an ejection fraction <30%, overt CHF, hypokalemia and alkalemia will be excluded.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

468Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sodium bicarbonate	Drug	isotonic sodium bicarbonate at 3 cc/kg for one hour followed by 2 cc kg/hr for 4 hours

Measure	Description	Time Frame
Incidence of contrast induced nephropathy		48-72 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

serum creatinine greater then or equal to 1.5

Exclusion Criteria:

EF<30
Overt CHF
Alkalemia
Hypokalemia
GFR<20 cc/min

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jordan L Rosenstock, MD	Lenox Hill Hospital	Principal Investigator

Intervention Browse Module

MeSH Terms

ID	Term
D017693	Sodium Bicarbonate

Ancestor Terms

ID	Term
D001639	Bicarbonates
D002254	Carbonates
D002255	Carbonic Acid
D017554	Carbon Compounds, Inorganic

Browse Leaves

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Browse Branches

Not provided