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Comparison of the effect of hypertonic and normal saline on the success of resuscitation in patients with septic shock during the first three hours of treatment

Protocol summary

Study aim
Reducing the effects of septic shock with early treatment with hypertonic saline.
Design
Clinical trial with control group,with parallel groups,double-blind,randomized, phase 3 on 52 patients.For randomization based on a random sequence created from www.randomization.com and the order in which patients enter the study, they will be included in the control or intervention group.
Settings and conduct
Using random sampling and intensive care units, patients with severe sepsis are randomly divided (using closed envelopes) into two groups of control and intervention. Optical nerve diameter and hemodynamic parameters and gasometric parameters in the first and second hours The third treatment is recorded for comparison between the two groups. The subjects and the treating physician will be unaware of the intervention and control groups (double-blind)
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients with septic shock, age between 18-80 years Exclusion criteria:Patient dissatisfaction,patients with incurable disseminated malignancy,patients with hyperthermia,patients receiving colloidal solutions and any volume limitation restrictions.
Intervention groups
In the intervention group, 5% hypertonic saline is prescribed at the beginning of septic shock treatment. In the control group, conventional resuscitation (isotonic saline serum) is performed. In both groups, optic nerve diameter is measured by ultrasound before saline administration (without placebo).
Main outcome variables
Hemodynamic parameters (HR, SBP, DBP, MAP, CVP) and gasometric parameters (PH, PaCO2, PaO2, HCO3, BE, Lactate) and optic nerve diameter at the beginning of the study and in the first and second and third hours of intervention (optic nerve diameter At the beginning of the third hour of intervention), they are measured, recorded and compared.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20111212008384N7
Registration date: 2022-02-22, 1400/12/03
Registration timing: registered_while_recruiting

Last update: 2022-02-22, 1400/12/03
Update count: 0
Registration date
2022-02-22, 1400/12/03
Registrant information
Name
Arash Peivandi Yazdi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 5209
Email address
peivandia@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-04-20, 1401/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of hypertonic and normal saline on the success of resuscitation in patients with septic shock during the first three hours of treatment
Public title
Comparison of the effect of hypertonic and normal saline on the success of resuscitation in patients with septic shock
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with septic shock, Age between 80-18 years
Exclusion criteria:
Patient dissatisfaction, Patients with incurable disseminated malignancy, Patients with hypernatremia, Patients receiving colloidal solutions such as albumin, etc. Any volume-limiting restrictions such as irreversible heart failure
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 52
More than 1 sample in each individual
Number of samples in each individual: 10
The diameter of the optic nerve in both groups is measured and recorded by ultrasound before treatment and after 3 hours. Hemodynamic parameters (HR, SBP, DBP, MAP, CVP) and gasometric parameters during the first three hours of treatment are recorded for comparison in the two groups.
Randomization (investigator's opinion)
Randomized
Randomization description
After obtaining informed consent from the patient's first-degree relatives, patients are randomly divided into control and intervention groups (using sealed envelopes). For randomization based on a random sequence created from www.randomization.com and the order in which patients enter the study, they will be included in the control or intervention group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The subjects and the treating physician will be unaware of the intervention and control groups
Placebo
Not used
Assignment
Parallel
Other design features
The diameter of the optic nerve in both groups is measured and recorded by ultrasound before treatment and after 3 hours.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ibn Sina St., Imam Reza Hospital, Building 610, Surgical ICU
City
mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2021-12-14, 1400/09/23
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.665

Health conditions studied

1

Description of health condition studied
Septic shock
ICD-10 code
R57.2
ICD-10 code description
R57.2

Primary outcomes

1

Description
Hemodynamic parameters (heart rate, mean arterial pressure, systolic blood pressure, diastolic blood pressure, central venous pressure)
Timepoint
At the beginning of the patient's study and in the first, second and third hours of the intervention
Method of measurement
Hemodynamic parameters by monitoring device andCentral venous pressure rulers are measured

Secondary outcomes

1

Description
1- Gasometric parameters 2- Optical nerve diameter
Timepoint
At the beginning of the patient's study and in the first, second and third hours of the intervention (optic nerve diameter at the beginning and the third hour of the intervention), they are measured, recorded and compared.
Method of measurement
Gasometer and sonography device

Intervention groups

1

Description
In the intervention group, 5% hypertonic saline is prescribed at the rate of 5 cc per kg of body weight at the beginning of septic shock treatment.
Category
Treatment - Drugs

2

Description
In the control group, conventional resuscitation is performed (initial targeted treatment with 30 cc of isotonic saline per kilogram of body weight during the first 3 hours of septic shock).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital of Mashhad
Full name of responsible person
Arash Peyvandi Yazdi
Street address
Ibn Sina St., Imam Reza Hospital, Building 610, Surgical ICU
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
peivandia@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayyur Mobarhan
Street address
Ibn Sina St. Imam Reza Hospital Building 610 Surgical ICU
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
peivandia@mums.ac.ir
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Arash Peyvandi Yazdi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
intensive care
Street address
Ibn Sina St., Imam Reza Hospital, Building 610, Surgical ICU
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
peivandia@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Arash Peyvandi Yazdi
Position
Assistant Professo
Latest degree
Subspecialist
Other areas of specialty/work
intensive care
Street address
Ibn Sina St., Imam Reza Hospital, Building 610, Surgical ICU
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
peivandia@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Arash Peyvandi Yazdi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
intensive care
Street address
Ibn Sina St., Imam Reza Hospital, Building 610, Surgical ICU
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
peivandia@mums.ac.ir

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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