Protocol summary
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Study aim
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Determining the effect of L-carnitine supplementation on inflammatory factors, oxidative stress and clinical outcomes in patients with sepsis admitted to the intensive care unit (ICU)
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Design
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A double-blind, randomized controlled clinical trial with parallel groups on 60 patients. Randomization using a valid website and 4-blocking method.
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Settings and conduct
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This clinical trial will be performed on patients admitted to the ICU of Al-Zahra Hospital. L-Carnitine and placebo are given to the patient in exactly the same packaging. Patients and researchers will not be aware of the type of intervention.
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Participants/Inclusion and exclusion criteria
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Patients aged >=18 years with sepsis admitted to the Intensive Care Unit (ICU) of Al-Zahra Hospital
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Intervention groups
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Three doses of 1000 mg L-carnitine per day in the intervention group
Three doses of placebo 1000 mg daily in the control group
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Main outcome variables
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Before and after the study, inflammatory status including ESR and CRP, CBC, oxidative stress indices including TOS and TAC, The Acute Physiology and Chronic Health Evaluation (APACHE II), sequential organ failure assessment (SOFA), quick-SOFA (qSOFA) ) And the patient's nutritional status form in ICU (NUTRIC score), serum albumin, BUN and creatinine, liver function tests (ALT and AST) and LDH will be evaluated.
General information
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Reason for update
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Changes in some outcomes and the date of the participants' recruitment due to the conditions of the Covid-19 pandemic
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201129049534N1
Registration date:
2021-05-02, 1400/02/12
Registration timing:
prospective
Last update:
2023-01-19, 1401/10/29
Update count:
1
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Registration date
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2021-05-02, 1400/02/12
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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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2021-05-27, 1400/03/06
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Expected recruitment end date
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2022-05-27, 1401/03/06
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effects of L-carnitine supplementation on inflammatory factors, oxidative stress and clinical outcomes in sepsis patients admitted to the intensive care unit (ICU): A double-blind randomized clinical controlled trial
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Public title
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"The effects of L-carnitine supplementation on septic patients"
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Diagnosis of sepsis based on blood culture and approval of an ICU specialist and anesthesiologist and infectious disease specialist
Gastrointestinal with normal function and intestinal nutrition criteria
Accept informed consent
Age>=18
Exclusion criteria:
Patient or family dissatisfaction
Patients who are hospitalized in the ICU for less than 48 hours or do not have the possibility of intestinal feeding and patients who receive nutritional support with full intravenous feeding
Patients who do not have an indication for intestinal nutrition on the first day and are confirmed and predicted based on the diagnosis of the intensive care unit that they will not be able to receive intestinal nutrition in the future. (Nausea, persistent vomiting, ileus, intestinal obstruction, uncontrolled diarrhea (> 500 ml per day), high-output fistula (> 500 ml per day), intestinal inaccessibility, incomplete resuscitation and hemodynamic instability
Cancer patients undergoing chemotherapy and taking cisplatin
Patients taking anticonvulsants (phenobarbital and phenytoin)
Patients taking pivalic acid, valproic acid and Ifosfamide
Patients taking levetiracetam
Patients undergoing dialysis
Patients with hyperthyroidism and hypothyroidism
Pregnancy
Severe and progressive septic shock
Patients who are expected to die within 2 days of admission to the ICU
Patients with BMI<18.5 kg/m2 admitted to the ICU
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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
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization is done individually. Recruiting of each patient to the intervention or control groups is done randomly with the help of 4 blocking method. This is done using a valid website to generate random numbers. (Each patient enters the control group or the intervention group is done by using random numbers)
https://www.sealedenvelope.com/simple-randomiser/v1/lists
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Patients in the intervention group will receive daily commercial L-carnitine supplements. Patients in the control group also receive a placebo, both of which are packaged and coated (blinded) in the same color, shape and smell, and differ only in the mark marked on it (A or B).
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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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2021-03-03, 1399/12/13
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Ethics committee reference number
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IR.MUI.RESEARCH.REC.1400.037
Health conditions studied
1
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Description of health condition studied
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Sepsis
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ICD-10 code
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A41
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ICD-10 code description
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Other sepsis
Primary outcomes
1
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Description
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C reactive Protein (CRP)
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Timepoint
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At baseline and end of the study
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Method of measurement
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ELISA test
2
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Description
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Erythrocyte sedimentation rate (ESR)
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Timepoint
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At baseline and end of the study
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Method of measurement
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ELISA test
3
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Description
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Total antioxidant capacity (TAC)
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Timepoint
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At baseline and end f the study
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Method of measurement
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Commercial diagnostic kit
4
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Description
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Superoxide dismutase (SOD)
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Timepoint
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At baseline and end f the study
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Method of measurement
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Commercial diagnostic kit
Secondary outcomes
1
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Description
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28 mortality rate
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Timepoint
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End of the study
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Method of measurement
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Mathematically dividing the number of dead people by the total number of people using hospital records or telephone follow-up
2
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Description
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Complete blood count (CBC)
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Timepoint
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End of the study
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Method of measurement
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ELISA kits
Intervention groups
1
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Description
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Intervention group: 3000 mg of L-carnitine in 3 doses (1000 mg) 3 times a day for 7 days. From KAREN Trading Company
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Category
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Treatment - Drugs
2
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Description
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Control group: 3000 mg Maltodextrin in 3 doses (1000 mg) 3 times a day for 7 days. From KAREN Trading Company
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Category
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Placebo
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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Esfahan 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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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Information about the study will be published after the individuals are not identified and the project is completed.
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When the data will become available and for how long
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Access period starts 6 months after the results are published
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To whom data/document is available
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Only for researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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For further analysis
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From where data/document is obtainable
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Dr. Mohammad Bagherniya
email: bagherniya@nutr.mui.ac.ir
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What processes are involved for a request to access data/document
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After reviewing the request and making it fully clear about the purposes of using the data, the data will be provided.
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Comments
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