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IRCT2016041016473N7 IRCT 2016-05-07 Tabriz University of Medical Science Effect of N-Acetyl Cysteine on liver and kidney function tests after surgical bypass in obstructive jaundice patients Effect of N-Acetyl Cysteine on liver and kidney function tests after surgical bypass in obstructive jaundice patients 2016-03-20 anticipated 30 Complete https://irct.ir/trial/15414 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2-3 Obstruction of bile duct. Intervention 1: Intervention Group: N-acetylcysteine infusion for the first 48 hours plus standard treatment (hydration plus antibiotics after the surgery). Intervention 2: Control Group: Standard treatment only (hydration plus antibiotics after the surgery).
public Dr Farzad Kakaei
Imam Reza Hospital, Golgasht Street
Tabriz Iran (Islamic Republic of) +98 41 3334 1317 fkakaei@tbzmed.ac.ir Tabriz University of Medical ScienceS scientific Farzad Kakaei
Surgery group, Imam Reza hospital, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614695 +98 41 3334 1317 fkakaei@tbzmed.ac.ir Tabriz University Of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Age above 18 years and below 75; unable to treta with ERCP or radiologic intervention; common bile diameter over 10 mm; no indication for resection of obstructive jaundice (choledochal cyst or Whipple procedure); bilirubin level over 5 mg/dl Exclusion criteria: possibility of surgical resection (Whipple procedure or bile duct tumor resection); any contraindication for acetylcysteine injection (e.g. asthma, bronchospasm, angioedema or known hypersensitivity); liver cirrhosis or need for liver transplant according to clinical or surgical findings for any reason; known renal failure or heart failure; need for mechanical ventilation before surgery, septic shock resistant to inotrope ( Systolic blood pressure less than 90) before surgery; preoperative biliary drainage by ERCP or radiologic intervention; liver enzymes (ALT, AST) greater than 10 times the normal; acute viral hepatitis or any history of drug toxicity; known liver disease such as autoimmune hepatitis; hemolysis cases 18 years 75 years Both K83.1 Obstruction of bile duct Treatment - Drugs Treatment - Drugs Intervention Group: N-acetylcysteine infusion for the first 48 hours plus standard treatment (hydration plus antibiotics after the surgery) Control Group: Standard treatment only (hydration plus antibiotics after the surgery) Aspartate aminotransferase. Timepoint: Preoperative and postoperative days 1, 3, 5, 7, 10, 14, and 30. Method of measurement: Measurement of serum level. Alanine aminotransferase. Timepoint: Preoperative and postoperative days 1, 3, 5, 7, 10, 14, and 30. Method of measurement: Measurement of serum level. Alkaline phosphatase. Timepoint: Preoperative and postoperative days 1 3 .5 .7 .10 .14. Method of measurement: Measurement of serum level. Bilirubin. Timepoint: Preoperative and postoperative days 1, 3, 5, 7, 10, 14, and 30. Method of measurement: Measurement of serum level. INR. Timepoint: Preoperative and postoperative days 1, 3, 5, 7, 10, 14, and 30. Method of measurement: Blood test. Gamma glutamyl transferase. Timepoint: Preoperative and postoperative days 1 3 5 .7 .10 .14. Method of measurement: Measurement of serum level. Blood urea nitrogen. Timepoint: Preoperative and postoperative days 1, 3, 5, 7, 10, 14, and 30. Method of measurement: Measurement of serum level. Creatinine. Timepoint: Preoperative and postoperative days 1 3 5 .7 .10 .14. Method of measurement: Measurement of serum level. Mortality. Timepoint: Up to 30 days after surgery. Method of measurement: From clinical records and postdischarge follow up. Need for dialysis. Timepoint: After the operation time up to 30 days after surgery. Method of measurement: By clinical records and postdischarge followup. Need for mechanical ventilation. Timepoint: up to 30 days after surgery. Method of measurement: By clinical records and postdischarge followup. Pneumonia. Timepoint: After the operation till discharge. Method of measurement: By clinical records. Need for inotropes. Timepoint: After the operation till discharge. Method of measurement: By clinical records. Need for liver transplantation. Timepoint: After the operation till discharge or death. Method of measurement: By clinical records. Hepatic encephalopathy. Timepoint: After the operation till discharge or death. Method of measurement: By clinical records. Tabriz University of Medical Science Approved 2016-02-01 Tabriz University of Medical Sciences Golgasht Street, Tabriz, Iran Tabriz Iran (Islamic Republic of)