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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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130829014521N22
Enrollment
200
Registered
2023-04-26
Start date
2023-04-21
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICU admitted patients.

Interventions

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 wi

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: Referral ICU patients from other centers after 1 week admission in other ICUs. Pregnancy and breastfeeding

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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 st

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmihossein Sahebkar

Mashhad University of Medical Sciences

sahebkara@mums.ac.ir+98 51 3180 1100

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026