NCT01394419

Brief Summary

N-acetylcysteine may prevent acute kidney injury in high risk patients undergoing off-pump coronary artery bypass graft.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2010

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

September 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

March 6, 2013

Status Verified

March 1, 2013

Enrollment Period

1.6 years

First QC Date

July 13, 2011

Last Update Submit

March 4, 2013

Conditions

Postoperative Acute Kidney Injury After Off-pump Coronary Artery Bypass Graft

Outcome Measures

Primary Outcomes (1)

  • Incidence of acute kidney injury

    within 5 days after surgery

Study Arms (2)

NAC group

EXPERIMENTAL

N-acetylcysteine

Drug: N-acetylcysteine

Placebo group

PLACEBO COMPARATOR

Saline

Drug: Saline

Interventions

N-acetylcysteineDRUG

N-acetylcysteine 150 mg/kg bolus over 15 min after induction of anesthesia, followed by an infusion of 150 mg/kg/day for 24 hrs

NAC group
SalineDRUG

Equal volume of normal saline

Placebo group

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing off-pump coronary artery bypass surgery and meets more than one of the following criteria;
  • preoperative serum creatinine \> 1.4 mg/dl
  • Age \> 70 years
  • Diabetes mellitus
  • left ventricular ejection fraction \< 35 % or congestive heart failure (NYHA III or IV)
  • emergency surgery or re-operation

You may not qualify if:

  • preoperative acute renal failure, patients on dialysis, use of N-acetylcystein within 5 days of surgery, history of hypersensitivity to N-acetylcystein

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

Related Publications (1)

  • Song JW, Shim JK, Soh S, Jang J, Kwak YL. Double-blinded, randomized controlled trial of N-acetylcysteine for prevention of acute kidney injury in high risk patients undergoing off-pump coronary artery bypass. Nephrology (Carlton). 2015 Feb;20(2):96-102. doi: 10.1111/nep.12361.

    PMID: 25384603DERIVED

MeSH Terms

Interventions

AcetylcysteineSodium Chloride

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2011

First Posted

July 14, 2011

Study Start

September 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

March 6, 2013

Record last verified: 2013-03

Locations

KR(1)