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Trial record 14 of 15 for:    "Acute articular rheumatism"
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N-acetylcysteine for Renal Protection in Patients With Rheumatic Heart Disease Undergoing Valve Replacement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mostafa Samy Abbas, Assiut University
ClinicalTrials.gov Identifier:
NCT01704482
First received: October 9, 2012
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Cardiac Surgery for Rheumatic Valvular Heart Disease
Renal Dysfunction
 Drug: N-acetylcysteine
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: N-acetylcysteine for Renal Protection in Patients With Rheumatic Heart Disease Undergoing Valve Replacement.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assiut University:

Primary Outcome Measures:
  • Absolute change in serum creatinine from baseline to peak level [ Time Frame: within 5 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the relative change in serum creatinine. [ Time Frame: the first five postoperative days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • the urinary output [ Time Frame: the first five postoperative days ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: February 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01704482

Locations
Egypt
Assiut University hospital
Assiut, Egypt, 11111
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Mostafa Samy Abbas, assistant lecturer of anesthesia and ICU, Assiut University, Assiut University
ClinicalTrials.gov Identifier: NCT01704482     History of Changes
Other Study ID Numbers: tafanono01003060187
Study First Received: October 9, 2012
Last Updated: October 10, 2012
Health Authority: Egypt: Institutional Review Board

Additional relevant MeSH terms:
Rheumatic Fever
Heart Diseases
Heart Valve Diseases
Rheumatic Diseases
Rheumatic Heart Disease
Cardiovascular Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Acetylcysteine
N-monoacetylcystine
 Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on May 23, 2013