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IRCT20170903036041N4 IRCT 2023-04-30 Iran University of Medical Sciences The Effect of L-Carnitine supplementation administration rout on the prognosis of patients The Effect of L-Carnitine supplementation administration rout on inflammatory, metabolic markers and the prognosis of patients admitted to the intensive care unit 2023-04-21 anticipated 135 Complete https://irct.ir/trial/69458 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: After selecting the participants in the study using inclusion and non-inclusion criteria, to prevent the occurrence of bias in the selection of participants to intervention and control groups, we will use the randomization method to minimize the opinion of researchers in selecting participant to study groups. The block randomization method was used in this study. The size of the blocks is considered to be six and will be selected randomly so that it is not predictable to the participants based on the blocks. First, we will receive using Random Allocation software and by determining the sample size, the number of groups, the type of randomization and is random the order of the blocks in the software output and will be shown in the software output of groups with letters A, B and C. Then, after selecting each patient based on the inclusion and non-inclusion criteria, the project manager will be informed and he will tell the type of intervention of that patient based on the order of inclusion of patients and compliance with the number mentioned in the randomization output, Blinding description: We will inform the supervisor after selecting each patient for the study and they are based on the randomized output of the randomization software and its matching to the patient's number the interventions will be sent in a form that is not known to the patients, prescriptive, and evaluator of the outcomes. For this, the shape and color of the interventions will be the same. Blinding process in this study is double blinded. Participants in the study will be blinded of interventions also the physicians will be blinded of the type of interventions received by the participants when they evaluated the outcome. 3 Patients admitted to the intensive care unit. Intervention 1: Intervention group: L-carnitine capsules will be prescribed 1 gram orally, 4 times a day for 3-7 days. Intervention 2: Intervention group: L-carnitine will be administered intravenously over 12 hours a day, for 3-7 days. Intervention 3: Control group: Patients in this group will receive only the usual medical services and will not receive a placebo. 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 No decision has been made yet.
public Arzhang Ebrahimi Fard
Rasoul Akram hospital, Niyayesh St, Sattarkhan St
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6653 9260 emohaghegh96@yahoo.com Iran University of Medical Sciences scientific Omid Moradimoghadam
Rasoul Akram hospital, Niyayesh St, Sattarkhan St
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6653 9260 moradimoghadam.o@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients admitted to the Intensive Care Unit At least 17 years old 17 years no limit Both History of taking L-carnitine supplements in the last month Taking corticosteroids and NSAIDs Severe cardiovascular diseases Pregnancy Breastfeeding Z09.9 Follow-up examination after unspecified treatment for other conditions Treatment - Other Treatment - Other N/A Intervention group: L-carnitine capsules will be prescribed 1 gram orally, 4 times a day for 3-7 days. Intervention group: L-carnitine will be administered intravenously over 12 hours a day, for 3-7 days. Control group: Patients in this group will receive only the usual medical services and will not receive a placebo. C-Reactive Protein. Timepoint: The beginning of the study, the third and seventh days after the intervention. Method of measurement: Blood test. Erythrocyte Sedimentation Rate. Timepoint: The beginning of the study, the third and seventh days after the intervention. Method of measurement: Blood test. Fasting Blood Sugar. Timepoint: The beginning of the study, the third and seventh days after the intervention. Method of measurement: Blood test. Insulin. Timepoint: The beginning of the study, the third and seventh days after the intervention. Method of measurement: Blood test. Cholesterol. Timepoint: The beginning of the study, the third and seventh days after the intervention. Method of measurement: Blood test. Triglyceride. Timepoint: The beginning of the study, the third and seventh days after the intervention. Method of measurement: Blood test. Low-density lipoprotein. Timepoint: The beginning of the study, the third and seventh days after the intervention. Method of measurement: Blood test. High-density lipoprotein. Timepoint: The beginning of the study, the third and seventh days after the intervention. Method of measurement: Blood test. SOFA score. Timepoint: The beginning and end of the study. Method of measurement: SOFA checklist. APACHE II score. Timepoint: The beginning and end of the study. Method of measurement: APACHE II score. Nutrition score. Timepoint: The beginning and end of the study. Method of measurement: NUTRIC score. Length of stay. Timepoint: Hospitalization days. Method of measurement: Count the number of days. Iran University of Medical Sciences Approved 2023-02-22 Ethics committee of Iran university of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)