Comparative study of two fluid therapy methods with 5% glucose serum and 5% glucose in lactate ringer on serum glucose, sodium and potassium levels of neonates during and after surgery
Determination and comparison of two methods of fluid therapy with 5% glucose serum and 5% glucose in Ringer lactate on neonatal serum glucose, sodium and potassium levels during and after surgery
Design
In this double-blind randomized clinical trial study with parallel groups, 100 patients were randomly divided into two groups receiving 5% glucose serum and 5% glucose serum in ringer lactated by random allocation software.
Settings and conduct
This double-blind clinical trial study will be performed during 2021-2022 in Al-Zahra Hospital in Isfahan. Fluids are injected into the patient under the supervision of an anesthesiologist, but data collection will be performed by an experienced operating room staff member who is unaware of the infant's fluid therapy.
Participants/Inclusion and exclusion criteria
In this study, infants less than two months old who need surgery and do not have metabolic disorders are included in the study.
Intervention groups
100 baby infants for surgery are distributed in two groups of 50. In the first group, fluid therapy is performed using 5% dextrose serum and in the second group with 5% dextrose serum in ringer lactate.
Main outcome variables
Serum levels of blood glucose, sodium and potassium
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012782N57
Registration date:2021-11-29, 1400/09/08
Registration timing:prospective
Last update:2021-11-29, 1400/09/08
Update count:0
Registration date
2021-11-29, 1400/09/08
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-21, 1400/09/30
Expected recruitment end date
2022-03-19, 1400/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of two fluid therapy methods with 5% glucose serum and 5% glucose in lactate ringer on serum glucose, sodium and potassium levels of neonates during and after surgery
Public title
Comparison of fluid therapy with 5% glucose serum and 5% glucose in lactated ringer on serum glucose, sodium and potassium levels of infants during and after surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Infant candidate for surgery
Age less than 2 months
Parents' consent to participate in the study
Exclusion criteria:
Infant with metabolic disorders
Age
To 2 months old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of patients is done using Random Allocation Software. In this software, the total sample size and number of groups are entered into the software. The software output is a list that randomly distributes the entire sample size between the two groups. Patients are divided into two groups according to the time of referral and according to the mentioned list to complete the sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
The method of blinding is as follows: Fluids are injected into the patient under the supervision of an anesthesiologist, but data collection will be done by one of the experienced operating room personnel who is unaware of the type of fluid therapy for the infant. Also, the data analyzer is unaware of the type of fluid received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Sofeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Approval date
2020-12-27, 1399/10/07
Ethics committee reference number
IR.MUI.MED.REC.1399.861
Health conditions studied
1
Description of health condition studied
Hyper glycemia
ICD-10 code
R73.9
ICD-10 code description
Hyperglycemia, unspecified
Primary outcomes
1
Description
Serum level of blood Glucose
Timepoint
before, during and after surgery
Method of measurement
Glucometer
2
Description
Serum level of Sodium
Timepoint
Before. during and after surgery
Method of measurement
With laboratory testing
3
Description
Serum level of potassium
Timepoint
Before, during and after surgery
Method of measurement
With laboratory testing
Secondary outcomes
1
Description
Blood pressure
Timepoint
Before surgery, during surgery, during recovery and 24 hours after surgery
Method of measurement
Pulse oximetry
2
Description
Heart rate
Timepoint
Before surgery, during surgery, during recovery and 24 hours after surgery
Method of measurement
Pulse oximetry
3
Description
Percentage of blood oxygen saturation
Timepoint
Before surgery, during surgery, during recovery and 24 hours after surgery
Method of measurement
Pulse oximetry
Intervention groups
1
Description
Intervention group1: Fluid therapy using 5% serum dextrose
Category
Prevention
2
Description
Intervention group 2: Liquid therapy with 5% dextro serum in ringer lactate
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Mohamad Farhoudi
Street address
Sofeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 2174
Email
mohamad.farhoudi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Street address
Herar Herib street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3792 3060
Email
m_siavash@med.mui.ac.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
Mohamad Farhoudi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sofeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3668 2174
Email
mohamad.farhoudi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parvi Sajedi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sofeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 2174
Email
sahedi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi
Position
Statistical Consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 2174
Email
al.mehrabi@gmail.com
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
The plan belongs to a government organization and it is not possible to share it.