NCT00808795

Brief Summary

  • Contrast-induced nephropathy (CIN) is the third most common cause of hospital acquired acute kidney injury, accounting for 10% of all cases.
  • The pathophysiology of CIN is unclear. Possible mechanisms involve
  • Renal tubular injury by oxygen free radicals
  • Reducing renal blood flow which leads to acute tubular necrosis. Since N-acetylcysteine is an antioxidant as well as a vasodilator, it may work in two distinct ways, by preventing reduction in renal blood flow or contrast-induced oxidative damage.
  • The purpose of this study is to evaluate the efficacy of N-acetylcysteine compared to placebo for the contrast-induced nephropathy prevention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_3

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

April 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 16, 2008

Completed
Last Updated

December 16, 2008

Status Verified

December 1, 2008

Enrollment Period

6 months

First QC Date

December 13, 2008

Last Update Submit

December 15, 2008

Conditions

Radiocontrast-Induced NephropathyChronic Kidney DiseaseDiabetes Mellitus

Keywords

Acute kidney injurycontrast-induced nephropathyChronic kidney diseaseDiabetes mellitusN-acetylcysteine

Outcome Measures

Primary Outcomes (1)

  • Incidence of CIN, defined as increase in serum creatinine concentration>=0.5mg/dL(44.2micromol/L) or >=25% above baseline.

    48 hours after exposure to contrast medium

Secondary Outcomes (3)

  • Change in serum creatinine

    48 hours after exposure to contrast medium

  • Change in serum urea nitrogen

    48 hours after exposure to contrast medium

  • Change in Glomerular filtration rate(GFR)

    48 hours after exposure to contrast medium

Study Arms (2)

N-acetylcysteine

EXPERIMENTAL
Drug: N-acetylcysteine

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

N-acetylcysteineDRUG

NAC is to be orally administered at the dose of 600mg twice a day, starting 24h before the procedure (two doses before and two doses after the procedure).

N-acetylcysteine
PlaceboDRUG

Placebo of NAC is to be orally administered at the dose of 600mg twice a day, starting 24h before the procedure (two doses before and two doses after the procedure).

Placebo

Eligibility Criteria

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

You may qualify if:

  • Patients who have all of the following criteria:
  • Aged older than 18 years old
  • A history of diabetes mellitus for at least one year
  • chronic kidney disease, defined as serum creatinine concentration \>=1.5mg/dL for men and \>=1.4mg/dL for women.

You may not qualify if:

  • Acute coronary syndrome requiring primary or rescue coronary intervention within less than 12h
  • Cardiogenic shock
  • Current peritoneal or hemo-dialysis
  • A known allergy to NAC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehran Heart center

Tehran, Tehran Province, 1411713138, Iran

Location

Related Publications (1)

  • Amini M, Salarifar M, Amirbaigloo A, Masoudkabir F, Esfahani F. N-acetylcysteine does not prevent contrast-induced nephropathy after cardiac catheterization in patients with diabetes mellitus and chronic kidney disease: a randomized clinical trial. Trials. 2009 Jun 29;10:45. doi: 10.1186/1745-6215-10-45.

    PMID: 19563648DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicDiabetes MellitusAcute Kidney Injury

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Manouchehr - Amini, MD

    Tehran University of Medical Sciences, Nephrology Department of Dr. Shariati Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
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

December 13, 2008

First Posted

December 16, 2008

Study Start

April 1, 2006

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

December 16, 2008

Record last verified: 2008-12

Locations

IR(1)