Protocol summary

Study aim
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)
Design
A double-blind, randomized controlled clinical trial with parallel groups on 60 patients. Randomization using a valid website and 4-blocking method.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
Patients aged 20-65 years with sepsis admitted to the Intensive Care Unit (ICU) of Al-Zahra Hospital
Intervention groups
Three doses of 1000 mg L-carnitine per day in the intervention group Three doses of placebo 1000 mg daily in the control group
Main outcome variables
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

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201129049534N1
Registration date: 2021-05-02, 1400/02/12
Registration timing: prospective

Last update: 2021-05-02, 1400/02/12
Update count: 0
Registration date
2021-05-02, 1400/02/12
Registrant information
Name
Mohammad bagherniya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3183
Email address
bagherniya@nutr.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-27, 1400/03/06
Expected recruitment end date
2022-05-27, 1401/03/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
"The effects of L-carnitine supplementation on septic patients"
Purpose
Treatment
Inclusion/Exclusion criteria
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 20-65 years
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
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Blinding (investigator's opinion)
Double blinded
Blinding description
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).
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Vice-Chancellor in Research Affairs -Medical University of Isfahan
Street address
Hezar-jerib Avenue, Isfahan University of Medical Sciences, School of Nutrition and Food Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-03-03, 1399/12/13
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.037

Health conditions studied

1

Description of health condition studied
Sepsis
ICD-10 code
A41
ICD-10 code description
Other sepsis

Primary outcomes

1

Description
C reactive Protein (CRP)
Timepoint
At baseline and end of the study
Method of measurement
ELISA test

2

Description
Erythrocyte sedimentation rate (ESR)
Timepoint
At baseline and end of the study
Method of measurement
ELISA test

3

Description
Lactate dehydrogenase
Timepoint
At baseline and end of the study
Method of measurement
ELISA test

4

Description
complete blood count
Timepoint
At baseline and end of the study
Method of measurement
ELISA test

5

Description
Total oxidative stress
Timepoint
At baseline and end of the study
Method of measurement
Commercial diagnostic kit

6

Description
Total antioxidant capacity
Timepoint
At baseline and end f the study
Method of measurement
Commercial diagnostic kit

7

Description
The Acute Physiology and Chronic Health Evaluation II score
Timepoint
At baseline and end of the study
Method of measurement
Clinical evaluation

8

Description
sequential organ failure assessment score
Timepoint
At baseline and end of the study
Method of measurement
Clinical evaluation

9

Description
quick sequential organ failure assessment score
Timepoint
At baseline and end of the study
Method of measurement
Clinical evaluation

10

Description
NUTRIC score
Timepoint
At baseline and end of the study
Method of measurement
Clinical evaluation

11

Description
Alanine transaminase
Timepoint
At baseline and end of the study
Method of measurement
ELISA test

12

Description
Aspartate transaminase
Timepoint
At baseline and end of the study
Method of measurement
ELISA test

13

Description
Blood urea nitrogen
Timepoint
At baseline and end of the study
Method of measurement
ELISA test

14

Description
Creatinine
Timepoint
At baseline and end of the study
Method of measurement
ELISA test

15

Description
Albumin
Timepoint
At baseline and end of the study
Method of measurement
ELISA test

Secondary outcomes

1

Description
28 mortality rate
Timepoint
End of the study
Method of measurement
Mathematically dividing the number of dead people by the total number of people using hospital records or telephone follow-up

2

Description
Duration of hospitalization
Timepoint
End of the study
Method of measurement
Hospital records

Intervention groups

1

Description
Intervention group: 3000 mg of L-carnitine in 3 doses (1000 mg) 3 times a day for 7 days. From KAREN Trading Company
Category
Treatment - Drugs

2

Description
Control group: 3000 mg Maltodextrin in 3 doses (1000 mg) 3 times a day for 7 days. From KAREN Trading Company
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Mahdi Keshani
Street address
Hezar-jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Email
mahdikeshani1@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behruz Ataei
Street address
Hezar-jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 21 8145 5618
Email
ethics@behdasht.gov.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Bagherniya
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar-jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3972 3138
Email
bagherniya@nutr.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Bagherniya
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar-jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Email
bagherniya@nutr.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Bagherniya
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar-jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Email
bagherniya@nutr.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the study will be published after the individuals are not identified and the project is completed.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
For further analysis
From where data/document is obtainable
Dr. Mohammad Bagherniya email: bagherniya@nutr.mui.ac.ir
What processes are involved for a request to access data/document
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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