Protocol summary
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Study aim
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Evaluation of colchicine effects in patients with sepsis
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Design
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Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3. For randomization, the clinical trial randomization tool of https://ctrandomization.cancer.gov/ was used.
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Settings and conduct
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This double-blind randomized controlled clinical trial will be conducted in Imam-Reza Hospital in Tabriz on 44 participants aged 18 to 80 years old with sepsis. At the beginning of the study, the demographic and clinical information of the patients will be evaluated. The intervention group will be treated with colchicine at a dose of 1 mg for 10 days, and the control group will receive placebo for 10 days. In this study, none of the patients and researchers will know about the process of assigning patients to the intervention and placebo groups.
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Participants/Inclusion and exclusion criteria
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Patients with sepsis/inclusion criteria: 1- Aged 18 to 80 years 2- High CRP at baseline 3- Completing the consent form
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Intervention groups
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Patients in the intervention group will receive 1 mg of colchicine daily in addition to the standard treatments for 10 days. Patients in the control group will also receive placebo for 10 days.
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Main outcome variables
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Interleukin-6 level as primary outcome; Laboratory findings include CRP, ESR, procalcitonin, LDH, Cr, CBC, LFT; Duration of need for supplemental oxygen, duration of need for mechanical ventilation, and duration of need for vasopressor and SOFA Score
General information
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Reason for update
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Changing the schedule of sampling date
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20231017059748N1
Registration date:
2023-10-21, 1402/07/29
Registration timing:
prospective
Last update:
2024-10-04, 1403/07/13
Update count:
3
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Registration date
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2023-10-21, 1402/07/29
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-10-11, 1403/07/20
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Expected recruitment end date
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2025-03-05, 1403/12/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of colchicine effects in patients with sepsis: A double-blind, randomized clinical trial
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Public title
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Colchicine effects in patients with sepsis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
1- Sepsis patients 2 - Aged 18 to 80 years 3 - High CRP3 at baseline 4 - Consented patients
Exclusion criteria:
Exclusion criteria: 1- Hypersensitivity to colchicine or other components of the formulation, 2- Hepatic failure (Child-Puff score B and C), 3- Renal failure (eGFR <15 mL/min/1.73 m2), 4- Malignancy, 5- Pregnancy, 6- Breastfeeding 7- Concomitant use of fusidic acid- lasmiditan- nirmatrelvir- pacritinib- fexinidazole.
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Age
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From 18 years old to 80 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
44
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will be carried out using random allocation site (https://www.sealedenvelope.com/simple-randomiser/v1/lists) by blocked randomization method with random block size 4 and 6.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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After sample selection, the researcher and patients will not know about randomization and the allocation process to groups.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-07-02, 1402/04/11
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Ethics committee reference number
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IR.TBZMED.PHARMACY.REC.1402.002
Health conditions studied
1
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Description of health condition studied
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Sepsis
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ICD-10 code
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R65
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ICD-10 code description
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Symptoms and signs specifically associated with systemic inflammation and infection
Primary outcomes
1
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Description
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Interleukin-6 plasma level
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Timepoint
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before the start and day 4 of the study
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Method of measurement
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ELISA kit
Secondary outcomes
1
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Description
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Erythrocyte sedimentation rate
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Timepoint
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Days 1, 4, 10
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Method of measurement
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Blood sample
2
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Description
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C-reactive protein
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Timepoint
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Days 1, 4, 10
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Method of measurement
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Blood sample
3
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Description
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Procalcitonin plasma level
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Timepoint
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Days 1, 4
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Method of measurement
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Blood sample
4
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Description
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Liver function tests
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Timepoint
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Days 1, 4, 10
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Method of measurement
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Measurement of liver enzymes
5
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Description
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Cell blood count
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Timepoint
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Days 1, 4, 10
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Method of measurement
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Blood sample
6
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Description
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Serum creatinine
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Timepoint
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Days 1, 4, 10
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Method of measurement
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Blood sample
7
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Description
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Lactate dehydrogenase plasma level
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Timepoint
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Days 1, 4, 10
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Method of measurement
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Blood sample
8
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Description
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Duration of need for supplemental oxygen, duration of need for mechanical ventilation and duration of need for vasopressor
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Timepoint
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Days 1 to 10
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Method of measurement
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questionnaire
9
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Description
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The state of organ failure in sepsis
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Timepoint
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Days 1, 4, 10
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Method of measurement
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Sequential Organ Failure Assessment (SOFA) Score
Intervention groups
1
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Description
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Intervention group: Patients will receive 1 mg colchicine daily for 10 days in addition to usual treatments.
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients will receive a placebo daily for 10 days along with usual treatments
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All of the data of an article can be published after making patients unrecognized.
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When the data will become available and for how long
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After publishing of article until 6 months after publishing of the results
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To whom data/document is available
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Data will be available to researchers working in academic and scientific institutions.
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Under which criteria data/document could be used
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Researchers that request data will be permitted only to doing analysis according to ethics for scientific aims.
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From where data/document is obtainable
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Applicants can receive data by sending an E-mail to address of hamishehkar@gmail.com and get response from Dr. Hadi Hamishehkar.
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What processes are involved for a request to access data/document
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After contacting with corresponding author (Dr. Hadi Hamishehkar), data will be sent to the Tabriz Imam Reza Hospital ethics committee and after receiving permission, data will be sent to applicants.
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Comments
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