Evaluating the effect of melatonin on the prevention of postoperative atrial fibrillation and acute kidney and injury following open heart surgery

Phase 3

Recruiting

• Conditions: Condition 1: Atrial fibrillation. Condition 2: Acute kidney injury.; Atrial fibrillation and atrial flutter, unspecified; Postprocedural disorder of genitourinary system, unspecified

• Registration Number: IRCT20151227025726N11
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 14 January 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

patients who are candidates for elective CABG surgery in in a tertiary referral center

Exclusion Criteria

a need for valvular surgery along with CABG surgery
history of any supraventricular arrhythmias
history of taking any antiarrhythmic agents except for beta blockers,calcium channel blockers and cardiac glycosides
history of epilepsy or seizure disorders
history of cerebrovascular disorders
history of sleep pattern disorders
history of taking any drug affecting sleep pattern including benzodiazepines, antidepressants,antipsychotics, dopamin agonists and beta agonists
history of autoimmune disorders
chronic hepatic failure ( liver enzymes rises more than 3 times the upper limit of normal)
Chronic kidney disease (Stage IV & V) or patients with Glomerular Filtration Rate of lower than 30 ml/min
history of taking anti inflammatory agents within 2 weeks of admission except for statins
patients undergoing CABG surgery emergently
patients receiving magnesium

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Creatinine plasma LEVEL. Timepoint: Before surgery, first, second, third, fourth and fifth day after surgery. Method of measurement: ELISA.;Hs-CRP plasma LEVEL. Timepoint: Before surgery and 24 hours after surgery. Method of measurement: ELISA.;Incidence of atrial fibrillation. Timepoint: After surgery until 7 days. Method of measurement: Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Incidence of cardiac inflammation and injury. Timepoint: Before and 24 hours after surgery. Method of measurement: Measuring the amount of CK-MB and Troponin biomarker elevation in plasma sample by their kits.