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IRCT20151108024938N2 IRCT 2018-05-30 Mashhad University of Medical Sciences Evaluation of high-dose anti-inflammatory effects of l-carnitine Evaluation of high-dose anti-inflammatory effects of l-carnitine in patients with critical ill in the intensive care unit 2018-06-09 anticipated 50 Complete https://irct.ir/trial/30748 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: 25 patients with ARDS are simple randomly assigned to case and control groups. The entry of each patient into the case or control group will be randomized with the help of numbers in sealed envelopes, Blinding description: In this study, patients will be administered commercial L-carnitine liquid supplements at a dose of 3000 mg. Pasteurized drinking water will be used as a placebo. These will be randomly packaged and concealed (blinded) by a nurse. The medical team and the nutrition team will monitor the administration every day at specific hours. The patients will be given these supplements via gavage for a period of 7 days. 3 Critical ill in intensive care units. Intervention 1: intervention groups:25 patients with critical ill who receive commercially available l-carnitine supplements with a dose of 3000 Mg are given to the patients by nurses and supervised by the team during the specified period of time for 21 days in the treatment of Gavage. Intervention 2: Control group: 25 patients with Critical ill who receive pasteurized drinking water as a randomly packaged placebo are given to the patients by nurses and supervised by the team during the specified period of time for 21 days in the treatment of Gavage,the placebo is made that medical University of mashhad.Intervention groups and control groups are randomly assigned to case and control groups. Yes - There is a plan to make this available What will be shared: Evaluation of high-dose anti-inflammatory effects of lcarnitine in critical ill patients in the intensive care unit When: This may be provided as an absolute date 1398,starting 6 months after publication To whom: The research data is exclusively accessible to the researchers working at universities and centers for scientific research Conditions: Use of the data is only possible after publication of the article. Where to obtain: Mashhad medical university, yahyapourof951@mums.ac.ir ,farvehyahyapour, How to obtain: 6 Months Comments:
public Abdolreza Norozi
Imam Reza Hospital, Imam Reza Square
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3882 7034 Norouzya@mums.ac.ir Mashhad University of Medical Sciences scientific Abdolreza Norozi
Imam Reza Hospital, Imam Reza Square
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3882 7034 Norouzya@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age of 18 years older Conscious informed consent Critical ill patients Patients with recently diagnosed critical ill 18 years no limit Both Dissatisfaction with the patient or family of the patient to continue the intervention Patients with liver and kidney failure Patients who have cancer and are taking chemotherapy and cisplatin Patients taking phenobarbital and phenytoin anti-inflammatory drugs Patients taking pivolic acid, valproic acid, and fosfamide drugs Patients undergoing dialysis R69 Illness, unspecified Treatment - Drugs Treatment - Drugs intervention groups:25 patients with critical ill who receive commercially available l-carnitine supplements with a dose of 3000 Mg are given to the patients by nurses and supervised by the team during the specified period of time for 21 days in the treatment of Gavage. Control group: 25 patients with Critical ill who receive pasteurized drinking water as a randomly packaged placebo are given to the patients by nurses and supervised by the team during the specified period of time for 21 days in the treatment of Gavage,the placebo is made that medical University of mashhad.Intervention groups and control groups are randomly assigned to case and control groups. IL-6. Timepoint: The first of study,the end of study 21th day. Method of measurement: ELISA. Anthropometric indices. Timepoint: Before and after study. Method of measurement: ELISA. Mid-arm circumference (MAC). Timepoint: Before and after study. Method of measurement: . The height of each patient is measured in the lying state or through the length of the ulna and the circumference of the middle of the non-dominant hand arm with a non-transient strip meter with an accuracy of 5.5 cm. Severity of illness. Timepoint: Before and after study. Method of measurement: Based on APACHEII questionnaire. Examining organ dysfunction. Timepoint: Before and after study. Method of measurement: Based on sequential organ failure assessment (SOFA) questionnaire. NUTRIC score questionnaire. Timepoint: Before and after study. Method of measurement: Based on Nutrition Risk in Critically ill (NUTRIC) questionnaire. Acute Phosphorus Reactive Protein Level (CRP) Level - Inflammatory Cytokines Levels Including IL-10, IL-8 , IL-6, IL-4, IL-2, IL-1 β, IFN-γ, TNF-α. Timepoint: Before and after study. Method of measurement: ELISA. Procalcitonin Factor. Timepoint: before and after study. Method of measurement: ELISA. Mashhad University of Medical Sciences Approved 2018-04-09 Ethics committee of medical university of mashhad Imam Reza Hospital, Imam Reza Square Mashhad Razavi Khorasan Iran (Islamic Republic of)