Evaluation of Additive effect of sodium bicarbonate with early goal-directed therapy in the first three hours of hemodynamic management of patients with severe sepsis and septic shock in intensive care units of Imam Reza hospital, Mashhad
Investigating the increased possibility of stabilizing hemodynamics by restoring intravascular volumes along with the administration of sodium bicarbonate in the first 3 hours in severe sepsis and septic shock patients
Design
In this study, a triple blind clinical trial with parallel groups in phase 3, patients with severe sepsis or septic shock documented in the special care departments of Imam-Reza Hospital in Mashhad, randomly (blocked and in sealed envelopes) They are divided into two groups of 36 people, control and intervention.
Settings and conduct
The control group will receive the same conventional method of treatment (30 cc/kg of isotonic crystalloid serum during the first 3 hours) and in the intervention group, sodium bicarbonate will be administered at the rate of half of the deficit calculated to the same previous volume as the control group during 3 hours.
Participants/Inclusion and exclusion criteria
Patients with severe sepsis and septic shock aged between 18-80 years were included in the study and patients with non-satisfaction; patients with untreatable disseminated malignancy; patients with alkalotic gasometry; patients receiving sodium bicarbonate before admission; patients with hypernatremia; patients receiving colloidal solutions; and any type of volume restriction and sodium bicarbonate were excluded from the study.
Intervention groups
In the control group, the conventional method of resuscitation (Early Goal Directed Therapy) with 30 cc/kg of isotonic crystalloid serum during the first 3 hours, is performed (No placebo). In the intervention group, sodium bicarbonate is added to the volume of 30 cc/kg of same serum in the amount of half of the calculated bicarbonate deficiency during the first three hours.
Main outcome variables
Hemodynamic and gasometric parameters are the primary outcomes at the time of entering the study and three hours after the intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220310054246N1
Registration date:2023-04-17, 1402/01/28
Registration timing:prospective
Last update:2023-04-17, 1402/01/28
Update count:0
Registration date
2023-04-17, 1402/01/28
Registrant information
Name
Ehsan Noori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3602 8867
Email address
nourie981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Additive effect of sodium bicarbonate with early goal-directed therapy in the first three hours of hemodynamic management of patients with severe sepsis and septic shock in intensive care units of Imam Reza hospital, Mashhad
Public title
Evaluation of Additive effect of sodium bicarbonate with early goal-directed therapy in management of patients with severe sepsis and septic shock
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with severe sepsis
Patients with septic shock
Age between 18 and 80 years old
Exclusion criteria:
Dissatisfaction of patients
Patients with incurable diffuse malignancy
Patients with alkalotic gasometry
Patients receiving sodium bicarbonate prior to study entry
Patients with hypernatremia
Patients receiving colloidal solutions
Any type of limitation in the administration of volume and sodium bicarbonate
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed in a blocked manner. For this purpose, to prevent predictability of the next treatment, 15 blocks of 4 in the combination of letters A and B (ABAB, BAAB, BBAA, BABA, ABBA) and six double blocks were randomly selected and assigned to groups based on this division. Classification will be done. In order to hide the allocations, the type of treatment obtained will be placed in sealed envelopes and at the moment of treating the patients, their type of treatment will be revealed to the allocator of the sample into groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and the analyst and allocator of the samples will be unaware of the intervention and control groups. In order to hide the allocations, the type of treatment obtained will be placed in sealed envelopes and at the moment of treating the patients, their type of treatment will be revealed to the allocator of the sample into groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ghorashi Building, next to Hoveyzeh Cinema, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2022-07-05, 1401/04/14
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.230
Health conditions studied
1
Description of health condition studied
Severe sepsis and septic shock
ICD-10 code
R57.8
ICD-10 code description
Other shock
2
Description of health condition studied
Metabolic acidosis
ICD-10 code
E87.2
ICD-10 code description
Acidosis
Primary outcomes
1
Description
Investigating the possibility of increased stability of hemodynamic parameters such as blood pressure and heart rate
Timepoint
Before the intervention and three hours later
Method of measurement
Cardiac monitoring device
2
Description
Investigating the possibility of improving gasometric parameters such as acidity and sodium bicarbonate
Timepoint
Before the intervention and three hours later
Method of measurement
Performing gasometry of arterial blood samples in a laboratory manner
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Sodium bicarbonate solution with a concentration of 7.5% in the amount of half of the deficiency calculated by the method (weight*base base*0.3) will be added to the liquid volume calculated in the amount of 30 cc of isotonic crystalloid serum per kilogram of body weight in 3 hours.
Category
Treatment - Drugs
2
Description
Control group: The calculated volume of liquid is 30 cc of isotonic crystalloid serum per kilogram of body weight in 3 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Ehsan Noori
Street address
Ebne Sina St
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Fax
+98 51 3854 3031
Email
b.emamreza@mums.ac.ir
Web page address
https://emamreza.mums.ac.ir/index.php
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid ghayour mobarhan
Street address
Ghorashi Building, next to Hoveyzeh Cinema, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
Ghayourem@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
Ehsan Noori
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ebne Sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Fax
Email
nourie981@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Arash Peivandi Yazdi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Ebne Sina St
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 5261
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
Ehsan Noori
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ebne Sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Fax
Email
nourie981@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD