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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Placebo Comparator | received the same volume of normal saline as placebo |
|
| NAC | Active Comparator | received 150 mg/kg NAC in 200 ml of 5% glucose over 15 min through the central line after induction of anesthesia and intubation followed by 50 mg/kg of NAC in 500 ml of 5% glucose over 4 h |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Malondialdahyde (MDA) | MDA is a marker of oxidative stress and one of the end-products of lipid peroxidation. MDA level reflects the degree of lipid peroxidation. | Postoperative day one |
| Measure | Description | Time Frame |
|---|---|---|
| MDA | MDA is a marker of oxidative stress and one of the end-products of lipid peroxidation. MDA level reflects the degree of lipid peroxidation. | preoperative and second postoperative day |
| liver function tests |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasralainy Faculty of Medicine | Cairo | Egypt |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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Randomized controlled study
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quadrible blinded
|
| normal saline | Other | the same volume of normal saline |
|
|
ALT,AST,Bilirubin
| preoperative ,first ,and,second post operative days |
| hemodunamics | MAP, HR | intraoperative |
| extubation time | time needed for extubation | postoperative 24 hr. |
| tissue perfusion | Lactate | preoperative ,first ,and,second post operative days |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |