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IRCT20201129049534N1 IRCT 2021-05-02 Esfahan University of Medical Sciences "The effects of L-carnitine supplementation on septic patients" The effects of L-carnitine supplementation on inflammatory factors, oxidative stress and clinical outcomes in sepsis patients admitted to the intensive care unit (ICU): A double-blind randomized clinical controlled trial 2021-05-27 anticipated 60 Complete https://irct.ir/trial/55874 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done individually. Recruiting of each patient to the intervention or control groups is done randomly with the help of 4 blocking method. This is done using a valid website to generate random numbers. (Each patient enters the control group or the intervention group is done by using random numbers) https://www.sealedenvelope.com/simple-randomiser/v1/lists, Blinding description: Patients in the intervention group will receive daily commercial L-carnitine supplements. Patients in the control group also receive a placebo, both of which are packaged and coated (blinded) in the same color, shape and smell, and differ only in the mark marked on it (A or B). 3 Sepsis. Intervention 1: Intervention group: 3000 mg of L-carnitine in 3 doses (1000 mg) 3 times a day for 7 days. From KAREN Trading Company. Intervention 2: Control group: 3000 mg Maltodextrin in 3 doses (1000 mg) 3 times a day for 7 days. From KAREN Trading Company. Yes - There is a plan to make this available What will be shared: Information about the study will be published after the individuals are not identified and the project is completed. When: Access period starts 6 months after the results are published To whom: Only for researchers working in academic and scientific institutions Conditions: For further analysis Where to obtain: Dr. Mohammad Bagherniya email: bagherniya@nutr.mui.ac.ir How to obtain: After reviewing the request and making it fully clear about the purposes of using the data, the data will be provided. Comments:
public Mohammad Bagherniya
Hezar-jerib Ave
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3972 3138 bagherniya@nutr.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad Bagherniya
Hezar-jerib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3183 bagherniya@nutr.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Diagnosis of sepsis based on blood culture and approval of an ICU specialist and anesthesiologist and infectious disease specialist Gastrointestinal with normal function and intestinal nutrition criteria Accept informed consent Age>=18 18 years no limit Both Patient or family dissatisfaction Patients who are hospitalized in the ICU for less than 48 hours or do not have the possibility of intestinal feeding and patients who receive nutritional support with full intravenous feeding Patients who do not have an indication for intestinal nutrition on the first day and are confirmed and predicted based on the diagnosis of the intensive care unit that they will not be able to receive intestinal nutrition in the future. (Nausea, persistent vomiting, ileus, intestinal obstruction, uncontrolled diarrhea (> 500 ml per day), high-output fistula (> 500 ml per day), intestinal inaccessibility, incomplete resuscitation and hemodynamic instability Cancer patients undergoing chemotherapy and taking cisplatin Patients taking anticonvulsants (phenobarbital and phenytoin) Patients taking pivalic acid, valproic acid and Ifosfamide Patients taking levetiracetam Patients undergoing dialysis Patients with hyperthyroidism and hypothyroidism Pregnancy Severe and progressive septic shock Patients who are expected to die within 2 days of admission to the ICU Patients with BMI<18.5 kg/m2 admitted to the ICU A41 Other sepsis Treatment - Drugs Placebo Intervention group: 3000 mg of L-carnitine in 3 doses (1000 mg) 3 times a day for 7 days. From KAREN Trading Company Control group: 3000 mg Maltodextrin in 3 doses (1000 mg) 3 times a day for 7 days. From KAREN Trading Company 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. Total antioxidant capacity (TAC). Timepoint: At baseline and end f the study. Method of measurement: Commercial diagnostic kit. Superoxide dismutase (SOD). Timepoint: At baseline and end f the study. Method of measurement: Commercial diagnostic kit. 28 mortality rate. 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. Complete blood count (CBC). Timepoint: End of the study. Method of measurement: ELISA kits. Esfahan University of Medical Sciences Approved 2021-03-03 Ethics committee Vice-Chancellor in Research Affairs -Medical University of Isfahan Hezar-jerib Avenue, Isfahan University of Medical Sciences, School of Nutrition and Food Sciences Isfahan Isfehan Iran (Islamic Republic of)