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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00494637
Other study ID # L06.10.058
Secondary ID
Status Terminated
Phase N/A
First received June 29, 2007
Last updated January 27, 2009
Start date July 2007
Est. completion date January 2009

Study information

Verified date January 2009
Source Lenox Hill Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 468
Est. completion date January 2009
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- serum creatinine greater then or equal to 1.5

Exclusion Criteria:

- EF<30

- Overt CHF

- Alkalemia

- Hypokalemia

- GFR<20 cc/min

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Lenox Hill Hospital GE Healthcare

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of contrast induced nephropathy 48-72 hours Yes
See also
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Active, not recruiting NCT01402232 - REduction of rIsk for Contrast Induced Nephropathy
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Active, not recruiting NCT01456013 - Evaluation of RenalGuard® System to Reduce the Incidence of Contrast Induced Nephropathy in At-Risk Patients Phase 3
Recruiting NCT01399203 - Contrast Medium Volume and Contrast-induced Nephropathy After Percutaneous Coronary Intervention N/A