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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01704482
First Posted: October 11, 2012
Last Update Posted: October 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mostafa Samy Abbas, Assiut University
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Mostafa Samy Abbas, Assiut University:

Primary Outcome Measures:
  • Absolute change in serum creatinine from baseline to peak level [ Time Frame: within 5 days after surgery ]

Secondary Outcome Measures:
  • the relative change in serum creatinine. [ Time Frame: the first five postoperative days ]

Other Outcome Measures:
  • the urinary output [ Time Frame: the first five postoperative days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: October 9, 2012
First Posted: October 11, 2012
Last Update Posted: October 11, 2012
Last Verified: October 2012

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