Back to resultsN-acetylcysteine for Renal Protection in Patients With Rheumatic Heart Disease Undergoing Valve Replacement
Primary Purpose
Cardiac Surgery for Rheumatic Valvular Heart Disease, Renal Dysfunction
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
N-acetylcysteine
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Cardiac Surgery for Rheumatic Valvular Heart Disease
Eligibility 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.
Sites / Locations
- Assiut University hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
N-acetylcysteine
Glucose 5%
Arm Description
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
equivalent volume over the same period.
Outcomes
Primary Outcome Measures
Absolute change in serum creatinine from baseline to peak level
Secondary Outcome Measures
the relative change in serum creatinine.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01704482
Brief Title
N-acetylcysteine for Renal Protection in Patients With Rheumatic Heart Disease Undergoing Valve Replacement
Official Title
N-acetylcysteine for Renal Protection in Patients With Rheumatic Heart Disease Undergoing Valve Replacement.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgery for Rheumatic Valvular Heart Disease, Renal Dysfunction
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N-acetylcysteine
Arm Type
Experimental
Arm Description
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
Arm Title
Glucose 5%
Arm Type
Placebo Comparator
Arm Description
equivalent volume over the same period.
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Absolute change in serum creatinine from baseline to peak level
Time Frame
within 5 days after surgery
Secondary Outcome Measure Information:
Title
the relative change in serum creatinine.
Time Frame
the first five postoperative days
Other Pre-specified Outcome Measures:
Title
the urinary output
Time Frame
the first five postoperative days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laila H Mohamed, Prof
Organizational Affiliation
Assiut university hosiptal
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nawal A Gad El-rab, Prof
Organizational Affiliation
Assiut university hosiptal
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fatma A Abd El-Aal, Ass Prof
Organizational Affiliation
Assiut university hosiptal
Official's Role
Study Director
Facility Information:
Facility Name
Assiut University hospital
City
Assiut
ZIP/Postal Code
11111
Country
Egypt
12. IPD Sharing Statement
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N-acetylcysteine for Renal Protection in Patients With Rheumatic Heart Disease Undergoing Valve Replacement
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