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IRCT20220418054581N1 IRCT 2022-06-11 Artesh University of Medical Sciences Effect of L-carnitine on mortality in obese patients with coronavirus The effect of L-carnitine supplementation on mortality and serum levels of C-reactive protein in obese patients with coronavirus (nCov-2019) with acute respiratory failure admitted to intensive care unit 2022-07-23 anticipated 40 Complete https://irct.ir/trial/63056 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: After admitting the patient to the intensive care unit and obtaining the eligible criteria for inclusion in the study, individuals were randomly assigned envelopes containing unique codes generated by the standard site (www.sealedenvelope.com). Codes with groups (A and B) were initially produced by one of the project facilitators who is not involved in any clinical phases of intervention and sampling and will remain with them until the end of the study and other researchers until the end of the study of the concept of codes and the groups will remain uninformed. On the envelopes, only the codes A or B are inserted to specify two separate groups. After assigning each envelope to the patient admitted to the study, the envelope is opened and the code inside the envelope, which contains two letters and a number (for example, XY3), which has no meaning and does not indicate any meaning, and is completely random, will be inserted on the supplement box. Patients are only classified according to code A or B, and the numbers in the envelope are not a criterion for classification or indication of belonging to a specific group. These codes are used only for labeling on medicine and placebo BOXS, Blinding description: The drugs and placebos in this study are exactly the same. In the present study, L-carnitine and placebo capsules are produced in exactly the same volume, color, odor, and size and are provided to the nurse or nutritionist in the same package. All researchers conducting the study, nurses, physicians, and data collectors will be kept blind to the type of supplements and groups assigned. As each patient enters the study, an envelope containing the code is randomly selected, and after opening the envelope, the code inside it is recorded on the supplement box of the same group as the code on the envelope and is assigned to the patient. Therefore, before and after selecting the patient, none of the researchers and the clinical team will be aware of the type of supplement the patient is receiving.After assigning a supplement or placebo to the patient, the nurse dissolves the supplements or placebo in 30 cc of water and feeds the patient every 8 hours through a nasogastric tube. For this reason, the nurse, physician, and patient will not be informed of the type of supplement or placebo received during the study. 3 Acute respiratory infection caused by coronavirus. Intervention 1: Intervention group: Oral supplement with high dose of carnitine capsule (1000 mg / 3 times a day) in patients with acute pulmonary infection due to coronavirus in the intensive care unit. Intervention 2: Control group: Oral supplement supplement with starch capsule water (1000 mg / 3 times a day) in patients with acute pulmonary infection caused by coronavirus in intensive care unit. 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 There is no further information
public Seyyed Mostafa Arabi
Janbazan Street
Mashhad Iran (Islamic Republic of) 9178939419 +98 935 351 9127 mostafa.arabi.nu@gmail.com Neyshabour University of Medical Sciences scientific Seyyed Mostafa Arabi
Sayyad Shirazi Street
Mashhad Iran (Islamic Republic of) 9178939419 +98 935 351 9127 mostafa.arabi.nu@gmail.com Neyshabour University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years Diagnosis of clinical and laboratory signs of severe Covid-19 Body mass index above 29.9 kg per square meter based on the weight in the file Completion of the informed consent form by the patient or his / her legal guardian Severe COVID-19 patients who are admitted to the medical ICU (MICU) and will require respiratory support Patients with normal GI function who receive enteral feeding 18 years no limit Both Receive any L-carnitine supplement in the last 6 months Participate in any other research project History of liver and kidney disease Pregnancy and lactation Any allergy to L-carnitine Patients who stayed in the ICU for < 72 hours Patients who receive parenteral nutritional support Patients treated with different drug regimens from the routine ICU protocol Patients will be ongoing treatment with cisplatin, phenobarbital, phenytoin, pivalic acid, valproic acid, ifosfamide, and levetiracetam Any gastrointestinal disorders that lead to stopping enteral feeding for more than 48 hours J06.9 Acute upper respiratory infection, unspecified Treatment - Drugs Placebo Intervention group: Oral supplement with high dose of carnitine capsule (1000 mg / 3 times a day) in patients with acute pulmonary infection due to coronavirus in the intensive care unit Control group: Oral supplement supplement with starch capsule water (1000 mg / 3 times a day) in patients with acute pulmonary infection caused by coronavirus in intensive care unit 28 days mortality. Timepoint: From the beginning of the intervention up to 28 days. Method of measurement: Record and view the file. Serum level of acute phase reactive protein C. Timepoint: The beginning of the intervention and day 7. Method of measurement: Biochemically and using the appropriate kit. Ratio of serum level of acute phase C-reactive protein to albumin. Timepoint: The beginning of the intervention and day 7. Method of measurement: Biochemically and using the appropriate kit. ICU mortality. Timepoint: from beginning until ICU follow up. Method of measurement: Record and view the file. The number of ventilator-dependent days. Timepoint: The beginning of the intervention until day 7. Method of measurement: Record and view the file. Length of stay in the ICU. Timepoint: beginning of intervention until 7 days later. Method of measurement: record and view of files. Serum levels of neutrophils and lymphocytes. Timepoint: beginning of intervention and 7 days later. Method of measurement: By biochemical methods and related kits. Artesh University of Medical Sciences Approved 2021-12-22 Ethics committee of Artesh University of Medical Sciences West Fatemi Ave, Tehran Tehran Tehran Iran (Islamic Republic of)