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

NCT01704482 | Completed Phase 2

• 1 other identifier: tafanono01003060187
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery for Rheumatic Valvular Heart Disease; Renal Dysfunction

Outcome Measures

Primary Outcomes (1)

• Absolute change in serum creatinine from baseline to peak level

  within 5 days after surgery

Secondary Outcomes (1)

• the relative change in serum creatinine.

  the first five postoperative days

Other Outcomes (1)

• the urinary output

  the first five postoperative days

Study Arms (2)

N-acetylcysteine

EXPERIMENTAL

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

Glucose 5%

PLACEBO COMPARATOR

equivalent volume over the same period.

Drug: placebo

Interventions

N-acetylcysteine 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

N-acetylcysteine

placebo DRUG

Glucose 5%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with rheumatic heart disease undergoing single valve replacement

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University hospital

Asyut, 11111, Egypt

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Laila H Mohamed, Prof

  Assiut university hosiptal

  STUDY CHAIR

• Nawal A Gad El-rab, Prof

  Assiut university hosiptal

  STUDY DIRECTOR

• Fatma A Abd El-Aal, Ass Prof

  Assiut university hosiptal

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of anesthesia and ICU, Assiut University

Study Record Dates

• First Submitted: October 9, 2012
• First Posted: October 11, 2012
• Study Start: February 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 11, 2012

Record last verified: 2012-10

Locations

EG (1)