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

NCT ID: NCT01704482

Last Updated: 2012-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Surgery for Rheumatic Valvular Heart Disease Renal Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

N-acetylcysteine

Intervention Type DRUG

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

Glucose 5%

equivalent volume over the same period.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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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

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mostafa Samy Abbas

assistant lecturer of anesthesia and ICU, Assiut University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laila H Mohamed, Prof

Role: STUDY_CHAIR

Assiut university hosiptal

Nawal A Gad El-rab, Prof

Role: STUDY_DIRECTOR

Assiut university hosiptal

Fatma A Abd El-Aal, Ass Prof

Role: STUDY_DIRECTOR

Assiut university hosiptal

Locations

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Assiut University hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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tafanono01003060187

Identifier Type: -

Identifier Source: org_study_id