Critically ill stroke patients hospitalized in ICU.
Conditions
Interventions
Intervention 1: Intervention group: Gavage of 10 grams of trehalose in the form of a 5 gram sachet 2 times a day (9 am and 9 pm) for 7 days through a nasogastric tube. The supplement will be purchased
Sponsors
Esfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Willingness to cooperate and sign the consent form by the patient or the patient's legal guardian Diagnosis of stroke by a specialist doctor and hospitalization in the intensive care unit (ICU) Age 18 to 80 years Stable hemodynamic and metabolic conditions in the first 24 to 48 hours Having enteral nutrition Not having food intolerance to food sources containing trehalose such as mushrooms Glasgow Coma Scale (GCS) =3
Exclusion criteria
Exclusion criteria: Having a history of cancer, autoimmune diseases, congenital metabolic diseases, underlying heart disease, kidney failure, liver failure and pancreatitis Patients who have cancer and are undergoing chemotherapy treatment. Pregnancy and breastfeeding. Impossibility of enteral nutrition in the first 48 hours of admission. Patients who are hospitalized in the intensive care unit for less than 48 hours. Patients undergoing dialysis. Patients who do not have an indication for enteral nutrition on the first day, and based on the diagnosis of the special care department, it is confirmed and predicted that they will not be able to receive enteral nutrition in the future. (nausea, persistent vomiting, ileus, intestinal obstruction, uncontrolled diarrhea (>500 mL/day), high-output fistula (>500 mL/day), intestinal inaccessibility, incomplete resuscitation, and hemodynamic instability. Patients who are under nutritional support by total intravenous nutrition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Catalase. Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Glutathione peroxidase (GPx). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Total antioxidant capacity (TAC). Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit.;Superoxide dismutase (SOD). Timepoint: Commercial diagnostic kit. Method of measurement: Commercial diagnostic kit.;Malondialdehyde (MDA). Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit.;C reactive Protein (CRP). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Erythrocyte sedimentation rate (ESR). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Interleukin-6 (IL-6). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Interleukin-1-ß (IL-1-ß). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Tumor necrosis factor-alpha (TNF-a). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;28 and 60-day mortality. Timepoint: End of the study. Method of measurement: Mathematically dividing the number of dead people by the total number of people using hospital records or telephone follow-up.;SOFA score. Timepoint: At baseline and end f the study. Method of measurement: hospital records.;Glasgow Coma Scale (GCS). Timepoint: At baseline and end f the study. Method of measurement: hospital records. | — |
Secondary
| Measure | Time frame |
|---|---|
| Arterial blood gas test. Timepoint: At baseline and end of the study. Method of measurement: hospital records.;Complete blood cell count. Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Serum Albumin. Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;BUN. Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Creatinine (Cr). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Blood sugar (BS). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Low density lipoprotein (LDL). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;High-density lipoprotein (HDL). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Cholesterol. Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Triglycerides. Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Lactate dehydrogenase (LDH). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Alanine aminotransferase (ALT). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Aspartate aminotransferase (AST). Timepoint: At baseline and end of the study. Method of measurement: ELISA test. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShokoofeh Talebi
Esfahan University of Medical Sciences
Outcome results
None listed