NCT00494637

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
468

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2007

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2007

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

January 28, 2009

Status Verified

January 1, 2009

Enrollment Period

1.4 years

First QC Date

June 29, 2007

Last Update Submit

January 27, 2009

Conditions

Contrast Induced Nephropathy

Outcome Measures

Primary Outcomes (1)

  • Incidence of contrast induced nephropathy

    48-72 hours

Interventions

sodium bicarbonateDRUG

isotonic sodium bicarbonate at 3 cc/kg for one hour followed by 2 cc kg/hr for 4 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • serum creatinine greater then or equal to 1.5

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Sodium Bicarbonate

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium Compounds

Study Officials

  • Jordan L Rosenstock, MD

    Lenox Hill Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 29, 2007

First Posted

July 2, 2007

Study Start

July 1, 2007

Primary Completion

December 1, 2008

Study Completion

January 1, 2009

Last Updated

January 28, 2009

Record last verified: 2009-01