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General information
2023-11-22, 1402/09/01
2024-02-09, 1402/11/20
20232024-1102-2209 00:00:00
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Updating the process of entering patients into the study
Updating the process of entering patients into the study
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به روز رسانی فرایند ورود بیماران به مطالعه
به روز رسانی فرایند ورود بیماران به مطالعه
Protocol summary
Study aim
Determining the effectiveness of melatonin on inflammatory cytokines and clinical outcomes of sepsis patients admitted to the ICU
Design
A double-blind, randomized, phase 3 controlled clinical trial with a parallel group design on 60 patients.
The randbetween function in Excel will be used to select the blocks randomly.
Settings and conduct
The current study is a double-blind, randomized clinical trial with two intervention and control arms, which will investigate the effect of melatonin administration as an adjunctive treatment in sepsis patients hospitalized in the ICU of Imam Khomeini Hospital, Sari.
Participants/Inclusion and exclusion criteria
Patients with the early phase of sepsis,
Age over 18 years, not receiving antioxidant supplements, informed consent of the patient or his legal guardian to participate in the study.
Exclusion criteria: autoimmune diseases or cancer, septic shock and the need for inotropic or vasopressor drugs, hepatic or renal failure, intestinal obstruction, ileus, gastroparesis or other digestive conditions that can affect intestinal absorption.
Pregnancy and breastfeeding, history of sleep disorders, simultaneous presence in another study
Intervention groups
The intervention group: melatonin at a dose of 15 mg every night,
The control group will receive a placebo for the first 7 days of hospitalization in ICU
Main outcome variables
The IL-6 level,
The IL-10 level,
Total antioxidant capacity,
The number and types of WBCs, CRP, and procalcitonin,
The hospitalization duration,
Mortality rate,
Duration of ventilation and need for ventilation,
The SOFA score,
The GCS score,
General information
Reason for update
Updating the process of entering patients into the study
Acronym
IRCT registration information
IRCT registration number:IRCT20181104041551N4
Registration date:2024-02-01, 1402/11/12
Registration timing:prospective
Last update:2024-02-19, 1402/11/30
Update count:1
Registration date
2024-02-01, 1402/11/12
Registrant information
Name
Fateme Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 1700
Email address
f.heydari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-09, 1402/11/20
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of melatonin on inflammatory factors and clinical outcomes in sepsis patients hospitalized in the Intensive Care Unit
Public title
Evaluation of the effect of melatonin on inflammatory factors and clinical outcomes in sepsis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with early phase of sepsis
Not taking antioxidant supplements
Informed consent of the patient or his/her legal guardian to participate in the study
Exclusion criteria:
Autoimmune diseases or cancer
Septic shock that requires inotrope or vasopressor drugs
Hepatic failure
Renal failure requiring dialysis
Intestinal obstruction, ileus, gastroparesis, or other gastrointestinal conditions that can affect intestinal absorption
Pregnancy and breastfeeding
History of sleep disorders
Attending another study at the same time
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked random allocation method will be used to randomly assign the patients to two intervention groups and the control group. For this purpose, the "randbetween" formula will be used in Excel software. The generated numbers will be between 1 and 6. Then, based on the generated number, samples will be assigned to the intervention and control groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Melatonin and placebo medicine will be placed in separate packages. Only the main operator of the study will know how to assign the codes. The patient, the anesthesiologist (data collector) and the statistical evaluator will be blind in this study. At the end of the study, the codes will be broken for statistical analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee, Imam Hospital of Sari, Mazandaran University of Medical Sciences
Street address
Imam Hospital, Amir Mzandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
5714854367
Approval date
2023-08-14, 1402/05/23
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1402.084
Health conditions studied
1
Description of health condition studied
sepsis
ICD-10 code
A41
ICD-10 code description
Other sepsis
Primary outcomes
1
Description
The interleukin-6 level
Timepoint
At baseline and 7 days after (the end of study)
Method of measurement
Elysia kit
2
Description
The interleukin-10 level
Timepoint
At baseline and 7 days after (the end of study)
Method of measurement
Elysia kit
3
Description
WBC (diff), CRP and PCT
Timepoint
At baseline and 7 days after (the end of study)
Method of measurement
Laboratory report
4
Description
Total antioxidant capacity
Timepoint
At baseline and 7 days after (the end of study)
Method of measurement
Elysia kit
5
Description
SOFA score
Timepoint
At baseline and 7 days after (the end of study)
Method of measurement
Laboratory and clinical findings
Secondary outcomes
1
Description
Comparison of the effect of melatonin with placebo on the GCS in sepsis patients
Timepoint
Daily
Method of measurement
Clinical observation
2
Description
Comparison of the effect of melatonin with placebo on the need for ventilation and duration of ventilation in sepsis patients
Timepoint
Dialy
Method of measurement
Clinical observation
3
Description
Comparison of the effect of melatonin with placebo on the mortality rate of sepsis patients
Timepoint
Daily
Method of measurement
Clinical observation
Intervention groups
1
Description
Intervention group: Melatonin with a dose of 15 mg per day. It should be noted that the routine treatment of patients (such as receiving antibiotics, conventional supportive treatments, etc.) will not change during the intervention period. Entering this study will not lead to a change in the patient's routine treatment process. The duration of the intervention will be 7 days.
Category
Treatment - Drugs
2
Description
Control group: They will receive a pill that is similar in appearance and color to the intervention group but contains starch or lactulose.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Educational Hospital, Sari
Full name of responsible person
Fatemeh Heidari
Street address
Imam Khomeini Educational Hospital, Razi St.
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
fateme58@yahoo.com
Web page address
http://imamhospital.mazums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Pedram Ebrahimnezhad
Street address
Moalem Square - Vice President of Research of Mazandaran University of Medical Sciences