The Effect of L-Carnitine supplementation administration rout on inflammatory, metabolic markers and the prognosis of patients admitted to the intensive care unit

The effect of L-carnitine on inflammatory and metabolic markers and form of dministration (oral or injection) on the outcomes under study in Intensive Care Unit patients.

The design of the study is a parallel type that will be done in three groups. One group is control and two groups are as interventions with different methods in administering L-carnitine. 45 patients were considered for each group and method of blinding is double-blind.

This study is to investigate the effect of L-carnitine supplementation and its administration method on changes in inflammatory and metabolic markers. The setting of this study is the Intensive Care Unit of Rasool Akram Hospital, Iran University of Medical Sciences. The effect of the type of interventions prescribed will be measured on the results of the study in the determined days after the intervention. The participants in the study and the doctors evaluating the outcomes of the study will be unaware of the type of interventions received by the patients.

The include criteria is to be at least 17 years old and hospitalized in the Intensive Care Unit, also the non-include criteria is a history of taking L-carnitine and having a heart disease.

Patients will be randomly assigned to three groups. The control group will receive only placebo. The first intervention group will receive one gram of L-carnitine capsules every six hours for three to seven days, in addition to this, the second intervention group will receive three grams of L-carnitine intravenously every day for 12 hours for three to seven days. All study participants will receive all of their routine therapeutic interventions

inflammatory indicators; lipid profile; sofa score; Apache score; nutrition score, length of hospitalization; fasting blood sugar; Insulin resistance

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.

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.

Finding of the study, demographic data of participants in the study, in addition to descriptive and analytical analysis of variables.

Availability six months after the end of study.

Critical care fellowships, anesthesiologists, internists.

Anyone who has a request for information about the results of this research.

Iran University of Medical Sciences.

By referring to the central library and clinical trial center in Iran University of Medical Sciences can access to the documents of participants, data and results.