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Clinical Trials/NCT01704482
NCT01704482CompletedPhase 2

N-acetylcysteine for Renal Protection in Patients With Rheumatic Heart Disease Undergoing Valve Replacement.

Assiut University1 site in 1 country60 target enrollmentStarted: February 2011Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Absolute change in serum creatinine from baseline to peak level
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

We aim to investigate the efficacy of N-acetylcysteine (NAC) to attenuate acute renal dysfunction in patients with rheumatic valvular heart disease undergoing single valve replacement.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •patients with rheumatic heart disease undergoing single valve replacement

Exclusion Criteria

  • •End stage renal disease (plasma creatinine concentration ≥ 300 µmol/L)
  • •Emergency cardiac surgery
  • •Planned off-pump cardiac surgery
  • •Chronic inflammatory disease on immunosuppression
  • •Chronic moderate to high dose corticosteroid therapy (≥ 10 mg/day prednisone or equivalent)
  • •Age ≤ 18 years.

Arms & Interventions

N-acetylcysteine

Experimental

N-acetylcysteine bolus of 150 mg/kg in 250 mL of 5% glucose over 15 mins, followed by continuous intravenous infusion of 50 mg/kg in 250 mL of 5% glucose over 4 hrs, then 100 mg/kg in 1000 ml of 5% glucose over 20 hrs

Intervention: N-acetylcysteine (Drug)

Glucose 5%

Placebo Comparator

equivalent volume over the same period.

Intervention: placebo (Drug)

Outcomes

Primary Outcomes

Absolute change in serum creatinine from baseline to peak level

Time Frame: within 5 days after surgery

Secondary Outcomes

  • the relative change in serum creatinine.(the first five postoperative days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mostafa Samy Abbas

assistant lecturer of anesthesia and ICU, Assiut University

Assiut University

Study Sites (1)

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