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

October 10, 2012 updated by: Mostafa Samy Abbas, Assiut University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 11111
        • Assiut University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: N-acetylcysteine
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
Drug: N-acetylcysteine
NAC 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
Placebo Comparator: Glucose 5%
equivalent volume over the same period.
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute change in serum creatinine from baseline to peak level
Time Frame: within 5 days after surgery
within 5 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
the relative change in serum creatinine.
Time Frame: the first five postoperative days
the first five postoperative days

Other Outcome Measures

Outcome Measure
Time Frame
the urinary output
Time Frame: the first five postoperative days
the first five postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Laila H Mohamed, Prof, Assiut university hosiptal
  • Study Director: Nawal A Gad El-rab, Prof, Assiut university hosiptal
  • Study Director: Fatma A Abd El-Aal, Ass Prof, Assiut university hosiptal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

October 9, 2012

First Submitted That Met QC Criteria

October 10, 2012

First Posted (Estimate)

October 11, 2012

Study Record Updates

Last Update Posted (Estimate)

October 11, 2012

Last Update Submitted That Met QC Criteria

October 10, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tafanono01003060187

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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