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IRCT20221206056734N2 IRCT 2025-03-07 Tabriz University of Medical Sciences The effect of L-carnitine in critically ill children admitted to PICU The Effect of L-Carnitine Supplementation on Some Inflammatory Biomarkers in Critically Ill Children in the Pediatric Intensive Care Unit (PICU): A Triple-Blind, Randomized Controlled Clinical Trial 2025-02-03 anticipated 38 Complete https://irct.ir/trial/81521 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization is used to allocate participants to each study group randomly. For this study, six blocks of six participants each have been considered, with an equal number of participants assigned to the intervention and control groups within each block. The unit of randomization in this study is individual-based, and a random number table will be used for the allocation process, Blinding description: The supplements and placebos were provided by Pars Behrouzan Jam Pharmaceutical Company and labeled with two-letter codes. All patients, researchers, data analysts, and outcome assessors will remain blinded to the contents of each label until the end of the study. 3 Critically ill children admitted to the PICU. Intervention 1: Intervention group: 19 critically ill children admitted to the PICU will receive 50 to 100 mg/kg of liquid oral L-carnitine, produced by Pars Behrouzan Jam Company, along with tube feeding for 7 days. Intervention 2: Control group: 19 critically ill children admitted to the ICU will receive 50 to 100 mg/kg of distilled water, produced by Pars Behrouzan Jam Company, along with tube feeding for 7 days. 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 further information is available.
public Maryam Behrooz
Zahra Mardani Azari Pediatric Research and Educational Center, Mardani Azari Street, Kheavaran Town.
Tabriz Iran (Islamic Republic of) 5367153121 +98 41 3159 5050 mm.behrooz@gmail.com Tabriz University of Medical Sciences scientific Maryam behrooz
Zahra Mardani Azari Pediatric Research and Educational Center, Mardani Azari Street, Kheavaran Town.
Tabriz Iran (Islamic Republic of) 5367153121 +98 41 3159 5050 mm.behrooz@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) The age range of one month to 12 years. Critically Ill children expected to stay in the PICU for more than 7 days Legal guardian's consent. 1 month 12 years Both Having liver or kidney diseases that contraindicate L-carnitine use. Children undergoing hemodialysis Children undergoing chemotherapy NPO patients who cannot start enteral nutrition Treatment - Drugs Placebo Intervention group: 19 critically ill children admitted to the PICU will receive 50 to 100 mg/kg of liquid oral L-carnitine, produced by Pars Behrouzan Jam Company, along with tube feeding for 7 days. Control group: 19 critically ill children admitted to the ICU will receive 50 to 100 mg/kg of distilled water, produced by Pars Behrouzan Jam Company, along with tube feeding for 7 days. Serum C-Reactive Protein (CRP). Timepoint: Before the start of the intervention and 7 days after the start of the intervention. Method of measurement: Blood test. Serum ESR. Timepoint: Before the start of the intervention and 7 days after the start of the intervention. Method of measurement: Blood test. Serum Total Antioxidant Capacity (TAC). Timepoint: Before the start of the intervention and 7 days after the start of the intervention. Method of measurement: Blood test. Serum Malondialdehyde (MDA). Timepoint: Before the start of the intervention and 7 days after the start of the intervention. Method of measurement: Blood test. Serum neutrophil to lymphocyte ratio (NLR). Timepoint: Before the start of the intervention and 7 days after the start of the intervention. Method of measurement: Blood test. Serum monocyte to lymphocyte ratio (MLR). Timepoint: Before the start of the intervention and 7 days after the start of the intervention. Method of measurement: Blood test. Serum platelet-to-lymphocyte ratio (PLR). Timepoint: Before the start of the intervention and 7 days after the start of the intervention. Method of measurement: Blood test. Superoxide Dismutase. Timepoint: Before the start of the intervention and 7 days after the start of the intervention. Method of measurement: Blood test. Interleukin-6. Timepoint: Before the start of the intervention and 7 days after the start of the intervention. Method of measurement: Blood test. Total protein. Timepoint: Before the intervention and 7 days after the intervention. Method of measurement: Blood test. Serum Albumin. Timepoint: Before the intervention and 7 days after the intervention. Method of measurement: Blood test. Prognostic Nutritional Index (PNI). Timepoint: Before the intervention and 7 days after the intervention. Method of measurement: serum albumin (g/L) + 0.005 × total lymphocyte count per micro liter of blood. Systemic Immune-Inflammation Index (SII). Timepoint: Before the intervention and 7 days after the intervention. Method of measurement: platelet count × neutrophil count / lymphocyte count. Prognostic Index (PI). Timepoint: Before the intervention and 7 days after the intervention. Method of measurement: based on C-reactive protein (CRP) and white blood cell (WBC) count as follows: PI = 2 when both CRP > 1 mg/dL and WBC > 11×10⁹/L; PI = 1 when only one of these parameters is elevated; and PI = 0 when both parameters are within normal ranges. Glasgow Prognostic Score (GPS). Timepoint: Before the intervention and 7 days after the intervention. Method of measurement: based on serum C-reactive protein (CRP) (g/L) and serum albumin (g/L). The score ranges from 0 to 2. A GPS of 0 will be assigned when CRP < 10 g/L and albumin > 35 g/L. A GPS of 1 will be assigned when either CRP > 10 g/L or albumin < 35 g/L is present. A GPS of 2 will be assigned when both CRP > 10 g/L and albumin < 35 g/L are present. Tabriz University of Medical Sciences Approved 2024-12-02 Ethics Committee of Tabriz University of Medical Sciences Mardani Azari Street, Khavaran Town, Zahra Mardani Azari Children's Educational and Research Center Tabriz East Azarbaijan Iran (Islamic Republic of)