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IRCT20130829014521N22 IRCT 2023-04-26 Mashhad University of Medical Sciences The effect of Trehalose on survival of ICU admitted patients Evaluation of the effect of Trehalose on survival and severity of disease in patients admitted to the intensive care unit 2023-04-21 anticipated 200 Complete https://irct.ir/trial/68218 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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), Blinding description: 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). 2 ICU admitted patients. Intervention 1: Intervention group: IV infusion of trehalose (15 mg, intravenous speed of 4mlit/min) made by Dr. Rajabi Pharmaceutical Co. Intervention 2: Control group: Normal Saline 0.9% infusion with the same volume of intervention group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is This project conducts between different groups of basic and clinical sciences. All of the collaborators must satisfied with this item. We will decide about this part in future.
public Amihossein Sahebkar
School of Pharmacy, University Campus, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1100 sahebkara@mums.ac.ir Mashhad University of Medical Sciences scientific Amirhossein Sahebkar
School of Pharmacy, University Campus, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1100 sahebkara@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both Referral ICU patients from other centers after 1 week admission in other ICUs. Pregnancy and breastfeeding Treatment - Drugs Placebo Intervention group: IV infusion of trehalose (15 mg, intravenous speed of 4mlit/min) made by Dr. Rajabi Pharmaceutical Co. Control group: Normal Saline 0.9% infusion with the same volume of intervention group Mortality in ICU. Timepoint: During hospitalization in the ICU. Method of measurement: The mortality will be recorded in datasheets. No need to more measures. 60-days mortality. Timepoint: Mortality during the 60 days after entering to the study. Method of measurement: 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. BS (Blood Sugar). Timepoint: 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). Method of measurement: Blood test. Creatinine. Timepoint: 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). Method of measurement: Blood test. Liver enzymes including glutamic-oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase (SGPT). Timepoint: 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). Method of measurement: Blood test. Complete Blood Count (CBC). Timepoint: 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). Method of measurement: Blood test. CRP (C-reactive protein). Timepoint: 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). Method of measurement: Blood test. Blood pressure. Timepoint: 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). Method of measurement: Sphygmomanometer. GCS (Glascow coma scale). Timepoint: 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). Method of measurement: Add together the scores from eye opening, verbal response and motor response. APACHE (Acute Physiology and Chronic Health Evaluation). Timepoint: 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). Method of measurement: 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). SOFA (Sequential Organ Failure Assessment). Timepoint: 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). Method of measurement: According to scoring system (SOFA score is a scoring system that assesses the performance of several organ systems in the body). Richmond Agitation Sedation Score (RASS). Timepoint: 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). Method of measurement: According to scoring system (RASS is an instrument designed to assess the level of alertness and agitated behavior in critically-ill patients). Mashhad University of Medical Sciences Approved 2023-04-08 Research Ethics Committees of Mashhad University of Medical Sciences Ghoreshi Building, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)