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

Evaluating the effect of melatonin on the prevention of postoperative atrial fibrillation and acute kidney and injury (AKI) following coronary artery bypass grafting (CABG) surgery

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20151227025726N11
Enrollment
70
Registered
2018-12-02
Start date
2018-04-03
Completion date
Unknown
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention 1: Intervention group: Administration of 12 mg sublingual melatonin tablets the night before and one hour before surgery. Intervention 2: Control group: will not receive the drug.

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaghar Barati

Shahid Beheshti University of Medical Sciences

sgh_brt68@yahoo.com+98 21 8820 0118

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026