Evaluating the effect of oral melatonin in colistin induced nephrotoxicity in the intensive care unit

Melatonin effect on colistin Nephrotoxicity

Clinical trial with control group, with parallel groups, double-blind, randomized, 40 patients. Excel software rand function was used for randomization.

All patients admitted to the intensive care unit receiving colistin who have given informed consent and have not died prematurely in less than 72 hours, whose serum creatinine level at the onset of colistin should not be grater than 1.5 mg/dl And the intervention group received melatonin tablets made by nature made company with a dose of three mg per day and in the control group, the corresponding placebo in the same form. Patients are monitored daily for urine volume and blood levels of creatinine and urea until they receive cleistine, and will be assessed by AKIN and RIFLE criteria. To identify patients, the APACHEII score and the reason for admission to the patients 'ICU will be recorded upon arrival. Patients' demographic criteria will be recorded.

Admission requirements include all patients admitted to the General ICU who are being treated for Colistin Non-entry conditions include dissatisfaction of the patient or legal guardian and patients with renal insufficiency and increased serum creatinine

The intervention group of melatonin tablets made by nature made company with a dose of three mg per day through the gastric tube and in the control group, receive the corresponding placebo with the same dose. Patients are monitored daily for urine volume and blood levels of creatinine and urea until they receive colistin, and will be assessed by Acute kidney Injury Network (AKIN) and Risk, injury, Failure, loss,End stage (RIFLE) criteria.

Urine volume, which is measured daily in the ward, and serum creatinine level, which is measured daily by the hospital laboratory

Using statistical software tools randomized using random numbers to assign a code to each patient by the pharmacotrapist is done with the conceal. The distribution of melatonin to the intervention group and placebo to the control group is done by the ward nurses based on the accident reported by the pharmacotherapist. Researchers and nurses will not be aware of the results of randomization and the type of package they give to patients. The researcher provides the necessary medication for the nurses to perform the intervention.

In this double-blind study, the pharmacotherapist performs randomized statistical software using randomized statistical software. The drug and placebo are given a code and key about the drugs is given only to the principal investigator.

In this study, none of the patients' personal information will be shared. Only data that is shared relates to the main consequences of the intervention.

The access period starts 6 months after the results are published.

The data will be available to researchers at academic and scientific institutions as well as physicians.

Applicants are only allowed to use the information available to them only in clinical practice and should not publish this information.

Ways of contacting applicants: 1- Contact number: 09181110628 2- E-mail address: p.Shojaei @ sbmu.ac.ir 3- Address: Tehran, Shahid Madani St., Imam Hossein Hospital, Dr. Pouja Shojaei

Applicants should receive the necessary information within ten days after making a call to the announced numbers or sending an email.