Assessment of the vitamin B1 effect on the outcomes of patients with sepsis under mechanical ventilation in the general intensive care unit
Design
A double-blind, randomized clinical trial study with parallel groups and phase 3 on 56 patients. Randomization will be done with the block randomization method using Random allocation software.
Settings and conduct
This study will be conducted on patients with sepsis under mechanical ventilation admitted to the general intensive care unit of Urmia Imam Khomeini hospital. This study will be conducted as a double-blind study. The patient and the head of research will be blinded to the allocation of patients into intervention or placebo groups.
Participants/Inclusion and exclusion criteria
In this study, 56 patients under mechanical ventilation in the general intensive care unit will be included. The inclusion criteria will be patients over 18 years and sepsis patients. The patients with renal failure with a GFR of less than 15, vitamin B1 consumption during the last 15 days before hospitalization, hospitalization less than 4 days in ICU, and an indication for the administration of vitamin B1, such as alcohol poisoning will be excluded.
Intervention groups
In the intervention group, in addition to routine treatments, patients will receive oral vitamin B1 tablets (300 mg) on the second day of mechanical ventilation for up to 7 days. In the control group, patients will receive placebo tablets in addition to routine treatments.
Main outcome variables
duration of mechanical ventilation; SOFA score (Sequential Organ Failure Assessment); APACHE II score (Acute Physiology & Chronic Health Evaluation II).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220711055432N1
Registration date:2022-09-10, 1401/06/19
Registration timing:prospective
Last update:2022-09-10, 1401/06/19
Update count:0
Registration date
2022-09-10, 1401/06/19
Registrant information
Name
Mohammad Amin Valizade Hasanloei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3223 4897
Email address
valizadeh.ma@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the vitamin B1 effect on the outcomes of patients with sepsis under mechanical ventilation admitted to the general intensive care unit
Public title
Assessment of the vitamin B1 effect on the outcomes of patients with sepsis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Sepsis patients
Patients under mechanical ventilation for at least 24 hours
Age above 18 years
Exclusion criteria:
Renal failure with a GFR of less than 15
Vitamin B1 consumption during the last 15 days before hospitalization
Hospitalization less than 4 days in ICU
Having an indication for the administration of vitamin B1, such as alcohol poisoning
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into intervention or placebo groups using the block randomization method based on generated numbers by Random allocation software. Thus, in this software, first, the number of groups and the total determined sample size will be entered, and then in the block section, the Block randomization method will be implemented. According to the total sample size (56 patients), 14 blocks of 4 will be used. Patients will be allocated to intervention or placebo groups based on generated numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be conducted as a double-blind clinical trial. The patient and the researcher evaluating the outcomes will be blind to the allocation of patients into intervention or placebo groups. In the first stage, none of the patients will know about their assignment to intervention or placebo groups (Vitamin B1 and placebo tablets will be similar in shape, size, and color). In the second stage, the anesthesiologist will prescribe the drug (other than the outcome assessor), so the table of computer-generated numbers will be given to the anesthesiologist. The anesthesiologist will enter the patients into groups according to the order of numbers. Finally, the name of groups will be encoded with the letters A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Imam Khomeini Hospital, Urmia University of Medical Sciences
The Sequential Organ Failure Assessment (SOFA) Score
Timepoint
Before intervention and 1st, 3rd and 7th day after the intervention
Method of measurement
The Sequential Organ Failure Assessment (SOFA) index
3
Description
Acute Physiology and Chronic Health Evaluation (APACHE) II score
Timepoint
Before intervention and 1st, 3rd and 7th day after the intervention
Method of measurement
Acute Physiology and Chronic Health Evaluation (APACHE) II queationnaire
Secondary outcomes
1
Description
White blood cell count (WBC)
Timepoint
Before intervention and the 1st, 3rd and 7th day after the intervention
Method of measurement
Cell counter
2
Description
erythrocyte sedimentation rate (ESR)
Timepoint
Before intervention and the 1st, 3rd and 7th day after the intervention
Method of measurement
Flow Cytometry
3
Description
C-reactive protein (CRP)
Timepoint
Before intervention and the 1st, 3rd and 7th day after the intervention
Method of measurement
Elisa test
4
Description
Lactate dehydrogenase (LDH)
Timepoint
Before intervention and the 1st, 3rd and 7th day after the intervention
Method of measurement
Elisa test
5
Description
Neutrophil to lymphocyte ratio
Timepoint
Before intervention and the 1st, 3rd and 7th day after the intervention
Method of measurement
Blood sample
6
Description
Mortality
Timepoint
During hospitalization and 28 days after intervention
Method of measurement
Medical record/ phone call
Intervention groups
1
Description
Intervention group: Patients will receive oral vitamin B1 tablets (300 mg) on the second day of mechanical ventilation for up to 7 days in addition to routine treatments. The drug will be procured from Jalinous Pharmaceutical Company.
Category
Treatment - Other
2
Description
Control group: Patients will receive placebo tablets (300 mg) on the second day of mechanical ventilation for up to 7 days in addition to routine treatments. The placebo will be prepared by the pharmacy faculty of Urmia university of Medical Sciences.