Protocol summary
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Study aim
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Determination of the effect of mega does l-carnitine supplementation on the level of inflammatory factors in critically ill patients in ICU
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Design
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This randomized and double-blind clinical trial with parallel and control groups will be conducted on 50 patients who will be randomly selected using the random number table.
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Settings and conduct
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Critically ill patients admitted to the intensive care unit to Imam Reza Hospital, Mashhad, Iran are chosen as the participants of the study. In this double-blind study, sealed opaque envelopes will be used to conceal the sequencing. Intervention group will receive the L-carnitine and control will receive placebo. The participants and person responsible for data collection are blind to group allocation and the type of treatment.
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Participants/Inclusion and exclusion criteria
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inclusion criteria:• Age of 18 years older, Conscious informed consent
exteria criteria: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.
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Intervention groups
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The intervention group will receive 3000 mg L-carnitine liquid supplements (Darou Pakhsh, Tehran, Iran), orally for 7 days.
The control group will receive placebo (pasteurized drinking water) orally for 7 days.
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Main outcome variables
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Inflammation factors
General information
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Reason for update
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Title change
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20151108024938N2
Registration date:
2018-05-30, 1397/03/09
Registration timing:
prospective
Last update:
2024-01-11, 1402/10/21
Update count:
1
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Registration date
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2018-05-30, 1397/03/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-06-09, 1397/03/19
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Expected recruitment end date
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2019-06-09, 1398/03/19
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Actual recruitment start date
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2018-07-01, 1397/04/10
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Actual recruitment end date
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2019-09-21, 1398/06/30
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Trial completion date
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2019-10-02, 1398/07/10
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Scientific title
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Evaluation of high-dose anti-inflammatory effects of l-carnitine in patients with critical ill in the intensive care unit
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Public title
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Evaluation of high-dose anti-inflammatory effects of l-carnitine
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Purpose
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Health service research
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age of 18 years older
Conscious informed consent
Critical ill patients
Patients with recently diagnosed critical ill
Exclusion criteria:
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
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
2
at first and at the end of study has been take the blood (10 cc)
Actual sample size reached:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-04-09, 1397/01/20
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Ethics committee reference number
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IR.MUMS.fm.REC.1396.671
Health conditions studied
1
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Description of health condition studied
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Critical ill in intensive care units
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ICD-10 code
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R69
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ICD-10 code description
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Illness, unspecified
Primary outcomes
1
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Description
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IL-6
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Timepoint
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The first of study,the end of study 21th day
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Method of measurement
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ELISA
Secondary outcomes
1
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Description
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Anthropometric indices
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Timepoint
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Before and after study
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Method of measurement
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ELISA
2
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Description
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Mid-arm circumference (MAC)
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Timepoint
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Before and after study
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Method of measurement
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. 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.
3
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Description
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Severity of illness
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Timepoint
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Before and after study
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Method of measurement
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Based on APACHEII questionnaire
4
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Description
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Examining organ dysfunction
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Timepoint
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Before and after study
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Method of measurement
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Based on sequential organ failure assessment (SOFA) questionnaire
5
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Description
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NUTRIC score questionnaire
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Timepoint
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Before and after study
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Method of measurement
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Based on Nutrition Risk in Critically ill (NUTRIC) questionnaire
6
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Description
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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
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Timepoint
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Before and after study
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Method of measurement
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ELISA
7
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Description
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Procalcitonin Factor
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Timepoint
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before and after study
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Method of measurement
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ELISA
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Evaluation of high-dose anti-inflammatory effects of lcarnitine in critical ill patients in the intensive care unit
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When the data will become available and for how long
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This may be provided as an absolute date 1398,starting 6 months after publication
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To whom data/document is available
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The research data is exclusively accessible to the researchers working at universities and centers for scientific research
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Under which criteria data/document could be used
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Use of the data is only possible after publication of the article.
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From where data/document is obtainable
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Mashhad medical university,
yahyapourof951@mums.ac.ir ,farvehyahyapour,
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What processes are involved for a request to access data/document
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6 Months
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Comments
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