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Completed

NCT Number: NCT01704482

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

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.

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Key information

Conditions

Cardiac Surgery for Rheumatic Valvular Heart Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Dysfunction Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Assiut University hospital

Asyut, 11111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Placebo

Drug

Primary outcomes

  1. Absolute change in serum creatinine from baseline to peak level

    Time frame: within 5 days after surgery

Secondary outcomes

  1. the relative change in serum creatinine.

    Time frame: the first five postoperative days

Other outcomes

  1. the urinary output

    Time frame: the first five postoperative days

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 11, 2012
Registry last updated
Oct 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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