Oxidative Stress, Liver Dysfunction
Conditions
Keywords
MDA, liver function, N-acetylcystien
Brief summary
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).
Detailed description
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.
Interventions
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
OTHERnormal saline
the same volume of normal saline
Sponsors
Kasr El Aini Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
quadrible blinded
Intervention model description
Randomized controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Malondialdahyde (MDA) | 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
| Measure | Time frame | Description |
|---|---|---|
| MDA | 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. |
| liver function tests | preoperative ,first ,and,second post operative days | ALT,AST,Bilirubin |
| hemodunamics | intraoperative | MAP, HR |
| extubation time | postoperative 24 hr. | time needed for extubation |
| tissue perfusion | preoperative ,first ,and,second post operative days | Lactate |
Countries
Egypt
Outcome results
None listed