NCT00716001

Brief Summary

This study is to evaluate the efficacy of sodium bicarbonate plus N-acetylcysteine for the prevention of contrast-induced nephropathy.

Trial Health

50
Monitor

Trial Health Score

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

Status
unknown

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

Study Start

First participant enrolled

July 1, 2008

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 15, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Last Updated

July 15, 2008

Status Verified

July 1, 2008

Enrollment Period

11 months

First QC Date

July 2, 2008

Last Update Submit

July 11, 2008

Conditions

Chronic Renal Failure

Keywords

patients with chronic renal failure undergoing elective percutaneous coronary intervention

Study Arms (2)

NAC

ACTIVE COMPARATOR
Drug: N-acetylcysteine

nonNAC

PLACEBO COMPARATOR
Drug: N-acetylcysteine

Interventions

N-acetylcysteineDRUG
NACnonNAC

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with chronic renal failure(serum creatinine \>1.1mg/dl) undergoing elective percutaneous coronary intervention

You may not qualify if:

  • administered with sodium bicarbonate and/or N-acetylcysteine and/or contrast media within 72 hours.
  • pregnancy
  • congestive heart failure
  • allergy to sodium bicarbonate and/or N-acetylcysteine
  • hemodialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 2, 2008

First Posted

July 15, 2008

Study Start

July 1, 2008

Primary Completion

June 1, 2009

Last Updated

July 15, 2008

Record last verified: 2008-07