Protocol summary
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Study aim
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Evaluation of the effect of Trehalose on survival and severity of disease in patients admitted to intensive care unit
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Design
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Triple-blind parallel randomized clinical trial with control group, phase 2 on 200 patients. We will use the website (www.sealedenvelope.com) for randomization.
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Settings and conduct
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ICU admitted patients in Imam Reza hospital in Mashhad, with mentioned inclusion criteria, will be enrolled to this study after informed consent. They will be divided into two groups of intervention (Trehalose) and control (Normal saline). Before inclusion and in the fifth day of the study (or before discharge in case of discharging before the 5th day), blood sample will be taken to assess Blood Sugar (BS), Creatinine, liver enzymes, C-Reactive Protein and Complete Blood Count (CBC). Blood pressure, Glascow Coma Scale (GCS), APACHE, SOFA, Richmond Agitation Sedation Scale (RASS), along with mortality in ICU and 60-days mortality will be assessed and compared between two groups.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Patients admitted to ICU within the last 48 hours, over 18 years old, APACHE-II score > 15 (using values recorded from 24 hours before inclusion up to the time of inclusion), sign informed consent by the patients or his legal guardians.
Exclusion Criteria: referral ICU patients from other centers after 1 week admission in other ICUs, pregnancy and breastfeeding
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Intervention groups
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Intervention group: IV infusion of Trehalose (15 mg with infusion speed of 4 mlit/min) made by Dr. Rajabi Pharmaceutical Co.
Control group: Normal Saline 0.9% infusion with the same volume of the intervention group.
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Main outcome variables
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mortality in ICU, 60-days mortality, Blood Sugar, Creatinine, liver enzymes, C-Reactive protein, and CBC. Blood pressure, Glascow Coma scale (GCS), APACHE, SOFA, Richmond Agitation Sedation Scale (RASS).
General information
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Reason for update
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The minimum sample size was calculated as 182. Considering 10% drop out, we will try to enter 200 participants.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20130829014521N22
Registration date:
2023-04-26, 1402/02/06
Registration timing:
registered_while_recruiting
Last update:
2023-12-05, 1402/09/14
Update count:
2
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Registration date
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2023-04-26, 1402/02/06
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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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2023-04-21, 1402/02/01
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Expected recruitment end date
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2025-04-21, 1404/02/01
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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 the effect of Trehalose on survival and severity of disease in patients admitted to the intensive care unit
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Public title
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The effect of Trehalose on survival of ICU admitted patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients admitted to the ICU within 48 hours prior to inclusion
APACHE-II score > 15 (using values recorded from 24 hours before inclusion up to the time of inclusion)
Over 18 years old
Sign informed consent by the patients or his legal guardians
Exclusion criteria:
Referral ICU patients from other centers after 1 week admission in other ICUs.
Pregnancy and breastfeeding
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Age
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From 18 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
200
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization was done using the block sizes of 4 and 6 with randomization website (www.sealedenvelope.com). After randomization, the type of treatment is written A/B codes in separate papers. Using sequential numbering, a third party (who does not contact with patients) will numbered the vials with specific numbers related to the randomized codes (A,B).
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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As mentioned before, after randomization, the patients place in two groups of A/B and received the products similar in shape and color (blinding of participants). The physician/nurse who will give the vials to the participants, received the vials with randomized codes and is not aware of the grouping (so the physician is blind too). The information of the patients and theirs vial numbers will be written on datasheets (the blinding of the assessor). Data will be entered to the SPSS software with codes (the blinding of the analyzer).
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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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2023-04-08, 1402/01/19
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Ethics committee reference number
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IR.MUMS.REC.1402.026
Health conditions studied
1
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Description of health condition studied
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ICU admitted patients
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Mortality in ICU
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Timepoint
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During hospitalization in the ICU.
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Method of measurement
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The mortality will be recorded in datasheets. No need to more measures.
2
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Description
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60-days mortality
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Timepoint
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Mortality during the 60 days after entering to the study
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Method of measurement
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In case of hospitalization, the 60-days mortality will be assessed by using HIS (health information system) and the information in the hospital files. If the patient has been discharged from the hospital, the information will be obtained by phone call.
Secondary outcomes
1
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Description
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BS (Blood Sugar)
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Timepoint
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The blood sample will be taken before inclusion and in the fifth day of the study (In case of discharging before the 5th day, the blood sample will be taken before discharge).
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Method of measurement
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Blood test
2
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Description
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Creatinine
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Timepoint
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The blood sample will be taken before inclusion and in the fifth day of the study (In case of discharging before the 5th day, the blood sample will be taken before discharge).
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Method of measurement
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Blood test
3
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Description
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Liver enzymes including glutamic-oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase (SGPT)
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Timepoint
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The blood sample will be taken before inclusion and in the fifth day of the study (In case of discharging before the 5th day, the blood sample will be taken before discharge).
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Method of measurement
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Blood test
4
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Description
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Complete Blood Count (CBC)
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Timepoint
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The blood sample will be taken before inclusion and in the fifth day of the study (In case of discharging before the 5th day, the blood sample will be taken before discharge).
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Method of measurement
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Blood test
5
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Description
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CRP (C-reactive protein)
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Timepoint
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The blood sample will be taken before inclusion and in the fifth day of the study (In case of discharging before the 5th day, the blood sample will be taken before discharge).
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Method of measurement
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Blood test
6
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Description
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Blood pressure
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Timepoint
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The blood pressure will be recorded before inclusion and in the fifth day of the study (In case of discharging before the 5th day, the blood pressure will be taken before discharge).
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Method of measurement
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Sphygmomanometer
7
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Description
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GCS (Glascow coma scale)
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Timepoint
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The GCS will be recorded before inclusion and in the fifth day of the study (In case of discharging before the 5th day, the GCS will be taken before discharge).
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Method of measurement
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Add together the scores from eye opening, verbal response and motor response.
8
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Description
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APACHE (Acute Physiology and Chronic Health Evaluation)
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Timepoint
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The APACHE will be recorded before inclusion and in the fifth day of the study (In case of discharging before the 5th day, the APACHE will be taken before discharge).
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Method of measurement
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According to scoring system (APACHE is a severity-of-disease classification system that estimates mortality based on a number of laboratory values and patient signs taking both acute and chronic disease into account. This score will be calculated based on the guidelines and recorded in the checklist).
9
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Description
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SOFA (Sequential Organ Failure Assessment)
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Timepoint
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The SOFA will be recorded before inclusion and in the fifth day of the study (In case of discharging before the 5th day, the SOFA will be taken before discharge).
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Method of measurement
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According to scoring system (SOFA score is a scoring system that assesses the performance of several organ systems in the body).
10
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Description
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Richmond Agitation Sedation Score (RASS)
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Timepoint
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The RASS will be recorded before inclusion and in the fifth day of the study (In case of discharging before the 5th day, the RASS will be taken before discharge).
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Method of measurement
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According to scoring system (RASS is an instrument designed to assess the level of alertness and agitated behavior in critically-ill patients).
Intervention groups
1
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Description
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Intervention group: IV infusion of trehalose (15 mg, intravenous speed of 4mlit/min) made by Dr. Rajabi Pharmaceutical Co.
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Category
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Treatment - Drugs
2
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Description
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Control group: Normal Saline 0.9% infusion with the same volume of intervention group
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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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Mashhad 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available