Evaluation of efficacy and safety of colchicine in the treatment of sepsis
Design
This is a double-blinded, randomized clinical trial. Eligible patients will be assigned to one of the groups of the study according the permuted block randomization.
Settings and conduct
This double-blind randomized clinical trial is designed in Imam Khomeini Hospital Complex. Patients with diagnosis of sepsis will receive either colchicine one mg tablet or placebo daily for 5- 7 days concomitant with the recommended standard care. Patients will daily assessed regarding to the response to the therapy and probable side effects.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients over 18 years of age with diagnosis of sepsis
Exclusion criteria: Septic shock at the time of inclusion, need for a vasopressor, significant colchicine interactions with medications, renal or liver failure, colchicine contraindications , colchicine allergy history
Intervention groups
Control group: Patients will receive a placebo concomitant with standard interventions for sepsis according the protocol including primary supportive care, treatment of fluid and electrolyte disorders, metabolic support and antibiotics.
Intervention group: In addition to the standard interventions, patients will receive 1 mg of colchicine tablet (orally or through nasogastric tube) daily, starting at the time of sepsis diagnosis for 5 to 7 days.
Main outcome variables
Efficacy of colchicine on incidence of sepsis-induced organ failure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100228003449N32
Registration date:2024-12-08, 1403/09/18
Registration timing:registered_while_recruiting
Last update:2024-12-08, 1403/09/18
Update count:0
Registration date
2024-12-08, 1403/09/18
Registrant information
Name
Hossein Khalili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4715
Email address
khalilih@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-21, 1403/09/01
Expected recruitment end date
2025-04-21, 1404/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of colchicine in the treatment of sepsis
Public title
Colchicine in the treatment of sepsis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years old with diagnosis of sepsis
Exclusion criteria:
Septic shock at the beginning of the study and the need for a vasopressor
Conditions where colchicine interacts significantly with other medications
Renal or liver failure
Contraindications to colchicine
History of allergic reactions to colchicine
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by the method of random blocks. According to the sample size, six patients are included in each block. Random groups are ABABAB, BBAABA, AABBAB, AAA,BBB, AABBBA, BBBAAA, ABBAB, BAABBA, AAABBB and BABABA. Random numbers will be generated by Excel software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Colchicine and placebo tablets are same regarding shape, size, color and packaging. Each pack will labeled by a technician not involved in the study. The patient and research members are unaware of the contents of the
packages.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی تهران
Street address
خیابان قدس، دانشگاه علوم پزشکی تهران، تهران، ایران
City
تهران
Province
Tehran
Postal code
141761441
Approval date
2024-11-10, 1403/08/20
Ethics committee reference number
IR.TUMS.TIPS.REC.1403.148
Health conditions studied
1
Description of health condition studied
Sepsis
ICD-10 code
R65.0
ICD-10 code description
Systemic Inflammatory Response Syndrome of infectious origin without organ failure
Primary outcomes
1
Description
Efficacy of colchicine on the incidence of sepsis-induced organ failure
Timepoint
Daily for 5-7 days
Method of measurement
SOFA Score
Secondary outcomes
1
Description
ICU admission requirement
Timepoint
Daily for 5-7 days
Method of measurement
Daily assessment
2
Description
Vasopressor requirement
Timepoint
Daily for 5-7 days
Method of measurement
Review of patients medications chart
3
Description
Corticosteroid requirement
Timepoint
Daily for 5-7 days
Method of measurement
Review of patients medications chart
4
Description
Respiratory support requirement
Timepoint
Daily for 5-7 days
Method of measurement
Review of patients medical records
5
Description
28-day mortality
Timepoint
28 days after recruitment
Method of measurement
Medical records
6
Description
Length of ICU stay
Timepoint
Daily
Method of measurement
Medical records
Intervention groups
1
Description
Intervention group: Patients will receive placebo tablet (orally or though NG tube) once daily for 5-7 days along with supportive care, treatment of fluid and electrolyte disorders, metabolic support, and antibiotic therapy.
Category
Placebo
2
Description
Intervention group: Patients will receive colchicine tablet 1 mg (orally or through NG tube) daily for 5-7 days along with supportive care, treatment of fluid and electrolyte disorders, metabolic support, and antibiotic therapy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
مجتمع بیمارستانی امام خمینی
Full name of responsible person
حسین خلیلی
Street address
بلوار کشاورز
City
تهران
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 4715
Email
khalilih@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Street address
معاونت پژوهشی، دانشگاه علوم پزشکی تهران، خیابان قدس، تهران، ایران
City
تهران
Province
Tehran
Postal code
02166706141
Phone
+98 21 8898 7381
Email
ramin_kordi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
حسین خلیلی
Position
پروفسور
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of MedicalSciences, 16 Azar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 4715
Email
khalilih@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 4715
Email
khalilih@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 4715
Email
khalilih@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Results of the study will be published. The study protocol and statistical analysis will be included in the manuscript
When the data will become available and for how long
One year after finishing the study, data will be published and will be available in databases
To whom data/document is available
After permission form the sponsor, data of the study will be available for academic researchers, physicians and scientific institutes
Under which criteria data/document could be used
Other researchers are permitted to included the results in their systematic reviews and metaanalysis
From where data/document is obtainable
For this you may ask Hossein Khalili through following information: Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave.,Tehran, Iran Postal code: 1417614411 E-mail: khalilih@tums.ac.ir
What processes are involved for a request to access data/document
After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks