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Completed

NCT Number: NCT06486805

N-Acetyl Cysteine Effect on Liver Function After Mitral Valve Replacement

This study aimed at the impact of the N-acetyl cysteine on the improvement of liver function subsequently on-pum mitral valve replacement. Following a clinical trial design, 54 candidates of on-pump MVR, aged 18 to 70 years, with normal liver and renal function were selected. The candidates were randomly divided into intervention: IV150 mg/ kg N-acetyl cysteine over 15 min, and control groups (normal saline as placebo) (n = 27 in each group).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kasralainy Faculty of Medicine

Cairo, Egypt

About this study

In a randomized controlled prospective study conducted in a teaching hospital, after approval by the ethics committee and informed consent, 54 candidates for on-pump MVR, aged 18 to 70 years, with normal liver and renal function, were selected. The candidates were randomly divided into intervention: IV 150 mg/ kg N-acetyl cysteine over 15 min then 50 mg/kg over 4 hrs for 3 days, and control groups (normal saline as placebo) (n = 27 in each group).and we will assess the effect of NAC on intra-operative hemodynamics and post-operative its protective rule against oxidative stress and liver dysfunction.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age from 18 to 70 years
  • Both sexes
  • Patients undergoing on-pump elective MVR with cold cardioplegia.

Exclusion criteria

  • Patient refusal.
  • Allergy to any of the study medications.
  • Emergency procedures.
  • systolic dysfunction, left ventricular ejection fraction <40%.
  • Pre-existing hepatic dysfunction, which is defined as an increase in liver enzymes AST and ALT >10 times the baseline.
  • chronic use of drugs affecting liver functions, e.g., NSAIDs, steroids, and anticonvulsants.

Treatment and study plan

n acetyl cysteine

Drug

N-acetylcysteine (NAC) is a small molecule containing a thiol (sulfhydryl-containing) group, which has antioxidant properties and is freely filterable, thus making it readily accessible to the intracellular compartment

Other names: NAC

Normal Saline

Other

the same volume of normal saline

Other names: placebo

Primary outcomes

  1. Malondialdahyde (MDA)

    Time frame: Postoperative day one

    MDA is a marker of oxidative stress and one of the end-products of lipid peroxidation. MDA level reflects the degree of lipid peroxidation.

Secondary outcomes

  1. MDA

    Time frame: preoperative and second postoperative day

    MDA is a marker of oxidative stress and one of the end-products of lipid peroxidation. MDA level reflects the degree of lipid peroxidation.

  2. liver function tests

    Time frame: preoperative ,first ,and,second post operative days

    ALT,AST,Bilirubin

  3. hemodunamics

    Time frame: intraoperative

    MAP, HR

  4. extubation time

    Time frame: postoperative 24 hr.

    time needed for extubation

  5. tissue perfusion

    Time frame: preoperative ,first ,and,second post operative days

    Lactate

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

The Effect of N-Acetylcysteine on Liver Functions After Mitral Valve Replacement: A Randomized Controlled Trial

Acronym: NAC

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 5, 2024
Registry last updated
Aug 29, 2025

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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