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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Mazandaran University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is a plan to make this available
-
Study Protocol
-
Yes - There is a plan to make this available
-
Statistical Analysis Plan
-
Not applicable
-
Informed Consent Form
-
Yes - There is a plan to make this available
-
Clinical Study Report
-
Yes - There is a plan to make this available
-
Analytic Code
-
Not applicable
-
Data Dictionary
-
Not applicable
-
Title and more details about the data/document
-
Files related to the results of laboratory tests and statistical analyses
-
When the data will become available and for how long
-
After completing the study and publishing the article
-
To whom data/document is available
-
Researchers working in academic and scientific institutions
-
Under which criteria data/document could be used
-
Only statistical analyzes are allowed for use in review articles
-
From where data/document is obtainable
-
Dr Fatemeh Heydari
-
What processes are involved for a request to access data/document
-
Sending an email to Dr Fatemeh Heydari - checking the request - if approved, sending it to the requester
-
Comments
-