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The effect of Hydrocortisone,Vitamin C and Thiamine in treatment of patients with severe Sepsis/Septic shock in ICU

Protocol summary

Study aim
General purpose: The effect of a combination of hydrocortisone, vitamin C and thiamine in the treatment of patients with septic shock in intensive care units is investigated.
Design
Clinical trial with control group, with parallel, double-blind, randomized phase 2 on 50 patients, patients will be randomly divided into two groups by block method in the form of 4 blocks.
Settings and conduct
All patients with severe septic shock / sepsis admitted to the intensive care unit of Valiasr Hospital in Arak double blind study In this study, patients as well as the project data analyst and the project Intern who is responsible for completing the questionnaires will be unaware of the division of patients into two groups
Participants/Inclusion and exclusion criteria
Study entering criteria: A patient with a diagnosis of septic shock is admitted to the intensive care unit; No covid-19 disease (negative PCR); Age 18 years or above; No pregnancy; No G6PD deficiency disease; No initial diagnosis of:Stroke, Acute Coronary Syndrome, Active Gastrointestinal bleeding, Burns and Trauma; No use vasopressors for more than 24 hours before entering the study Study exiting criteria: Non cooperation
Intervention groups
Patients admitted to the intensive care unit with a diagnosis of severe sepsis / septic shock One group receives a combination of hydrocortisone and vitamin C and thiamine, and the other group receives routine treatment.
Main outcome variables
The duration of intubation, the length of stay in the intensive care unit, the length of stay in the hospital, the length of time the vasopressor is taken and the mortality at the end of 7 days will be recorded in two groups. SOFA score up to 7 days and CRP and lactate levels will be measured on days 1, 3 and 5. The severity of the disease will be measured by the APACHII criterion for up to 3 days.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220219054058N1
Registration date: 2022-03-01, 1400/12/10
Registration timing: registered_while_recruiting

Last update: 2022-03-01, 1400/12/10
Update count: 0
Registration date
2022-03-01, 1400/12/10
Registrant information
Name
Mobina Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 4617
Email address
mobinaaahosseini@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-01, 1400/12/10
Expected recruitment end date
2022-04-30, 1401/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Hydrocortisone,Vitamin C and Thiamine in treatment of patients with severe Sepsis/Septic shock in ICU
Public title
The effect of Hydrocortisone,Vitamin C and Thiamine in treatment of patients with severe Sepsis/Septic shock
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
NO covid 19 Disease(PCR negative) Age 18or higher No pregnancy No G6PD deficiency No initial diagnosis of: Stroke, Acute Coronary syndrome, Active Gastrointestinal bleeding, Burns and Trauma No use of vasopressors more than 24 hours before entering the study
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the double-blind study, in this study, patients as well as the project data analyst and the project partner intern who is responsible for completing the questionnaires will be unaware of the division of patients into two groups.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Valiasr hospital,Valiasr square,Khorram street
City
Arak
Province
Markazi
Postal code
3814957558
Approval date
2022-02-22, 1400/12/03
Ethics committee reference number
IR.ARAKMU.REC.1400.319

Health conditions studied

1

Description of health condition studied
septic shock,severe sepsis
ICD-10 code
R65.21
ICD-10 code description
Severe sepsis with septic shock

Primary outcomes

1

Description
Mortality rate, Duration of intubation, Duration of stay in the intensive care unit, Duration of vasopressor, CRP, Lactate, Severity of illness
Timepoint
Mortality at the end of 7 days, Intubation period up to 7 days, Mean daily disease intensity up to 3 days, Mean CRP level on the first, third and fifth day, Duration of stay in intensive care unit up to 7 days, Duration of hospital stay, Mean level Lactate on the first, third and fifth day, Duration of receiving vasopressor up to 7 days
Method of measurement
Questionnaire filled out by Intern

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in this group receive combined three drugs of Hydrocortisone (50 mg every 6 hours intravenously - Jaber Bin Hayan Pharmaceutical Company, Iran), Thiamine (200 mg in 50 ml of normal saline every 12 hours intravenously - Pouyan daroo , Iran), Vitamin C (1500 mg every 6 hours in 100 ml of normal saline intravenously - Osweh Pharmaceutical Company, Iran) for three days in addition to standard treatment in the Intensive care unit.
Category
Treatment - Drugs

2

Description
Control group: Patients in this group receive only standard treatment in the Intensive care unit.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Mobina Hosseini
Street address
Valiasr hospital, Valiasr square, Khorram street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
pr_valieasr@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Arak university of medical science, Sardasht
City
Arak
Province
Markazi
Postal code
3848170002
Phone
+98 86 3417 3501
Email
info@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mobina Hosseini
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
postal code 3813138483, Mahdiyar alley, Shariati street, Arak, Iran
City
Arak
Province
Markazi
Postal code
3813138483
Phone
+98 86 3222 4617
Fax
Email
Mobinaaahosseini@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mobina Hosseini
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
postal code 3813138483, Mahdiyar alley, Shariati street, Arak, Iran
City
Arak
Province
Markazi
Postal code
3813138483
Phone
+98 86 3222 4617
Fax
Email
Mobinaaahosseini@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mobina Hosseini
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
postal code 3813138483, Mahdiyar alley, Shariati street, Arak, Iran
City
Arak
Province
Markazi
Postal code
3813138483
Phone
+98 86 3222 4617
Fax
Email
Mobinaaahosseini@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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