NCT00353340

Brief Summary

The objective of this study is to assess the efficacy of sodium bicarbonate compared with sodium chloride and oral N-acetylcysteine (NAC ) pretreatment for prevention of contrast nephropathy in patients with advanced renal disease undergoing cardiac catheterisation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

February 25, 2010

Status Verified

February 1, 2010

Enrollment Period

3 years

First QC Date

July 17, 2006

Last Update Submit

February 24, 2010

Conditions

Acute Renal Failure Contrast Nephropathy

Keywords

sodium bicarbonate,n-acetylcisteine,contrast nephropathy,cardiac catheterisation

Outcome Measures

Primary Outcomes (1)

  • The incidence of contrast induced nephropathy, defined as 25% or more increase in serum creatinine within 2 days of contrast administration, will be assessed.

Interventions

n acetylcysteineDRUG
sodium bicarbonateDRUG
sodium chlorideDRUG

Eligibility Criteria

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

You may qualify if:

  • Eligible patients include individuals aged 18 year or older with GFR 15-60ml/min calculated by MDRD formula, who were scheduled to undergo cardiac catheterization. During the randomized study, consecutive eligible patients scheduled for exposure to the nonionic radiographic contrast agent iopamidol (796 mOsm/kg H2O, 755 mg of iopamidol per milliliter, and 370 mg iodine per milliliter) will be considered for enrollment.

You may not qualify if:

  • i. Serum creatinine levels more than 8mg/dl or GFR less than 15ml/min
  • ii. Change in serum creatinine levels of ³0.5mg/dl during the previous 24 hours.
  • iii. Preexisting dialysis
  • iv. Multiple myeloma.
  • v. Pulmonary edema.
  • vi. Uncontrolled hypertension (treated systolic blood pressure more than 160 mmHg, or diastolic blood pressure more than 100mmHg.)
  • vii. Emergency catheterization.
  • viii. Recent exposure to radiographic contrast (within two days of the study).
  • ix. Allergy to radiocontrast.
  • x. Pregnancy.
  • xi. Administration of dopamine, mannitol or NAC before the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zmc

Jerusalem, 91031, Israel

Location

MeSH Terms

Interventions

AcetylcysteineSodium BicarbonateSodium Chloride

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsBicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium CompoundsChloridesHydrochloric AcidChlorine Compounds

Study Officials

  • linda shavit, md

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2006

First Posted

July 18, 2006

Study Start

January 1, 2005

Primary Completion

January 1, 2008

Study Completion

May 1, 2009

Last Updated

February 25, 2010

Record last verified: 2010-02

Locations

IL(1)