comparing hospitalization outcome (mortality and duration), renal function and perfusion status in patients receiving normal saline versus lactated ringer in the Emergency Department
Design
We will divide study period to consecutive three days clusters and allocate each cluster to one study group using random table. Code of fluid (instead of name of fluid) will be written on pocket label. Just drug provider knows code of each fluid.
Settings and conduct
Emergency Department of Imam Reza Hospital at Kermanshah
Participants/Inclusion and exclusion criteria
ٍevery patient in the acute emergency ward that will receive fluid and
-there isn't any contraindication to one of each fluids and
-is not need to specific serum and
-is not need to receive any drug that has interaction with these fluids
Intervention groups
first group who receive normal saline and second group receive lactated ringer at the emergency department
Main outcome variables
in hospital mortality and hospitalization days, renal function, serum concentration of hydrogen ion, lactate, potassium, and chloride, 6 and 24 hours after fluid initiation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181105041562N1
Registration date:2018-11-19, 1397/08/28
Registration timing:prospective
Last update:2018-11-19, 1397/08/28
Update count:0
Registration date
2018-11-19, 1397/08/28
Registrant information
Name
Ali Aliee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3825 2948
Email address
ali.aliee@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial study of comparison of normal saline and lactated ringer for fluid therapy in emergency department of Imam Reza hospital
Public title
comparing crystaloids
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
all patients of emergency department that fluid prescribed for them
age more than 14
Exclusion criteria:
contraindication to each of these two fluids (according to FDA guideline)
need to another fluid for patient
need to infusion of drugs that can't infused with one of these fluids
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
1300
Randomization (investigator's opinion)
Randomized
Randomization description
each cluster will be defined as patients of 3 consequent days. clusters will allocate to each group using random number table. the person who is responsible for providing drugs will have allocation list of clusters.
Blinding (investigator's opinion)
Triple blinded
Blinding description
there is code of fluid (instead of name of fluid) on fluid pocket labels. Just drug providers knows the code of fluid.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
building No2, Kermanshah University of Medical Sciences, Beheshti Blvd, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714638381
Approval date
2018-09-11, 1397/06/20
Ethics committee reference number
IR.KUMS.REC.1397.574
Health conditions studied
1
Description of health condition studied
patients of emergency department of general hospitals that receive intravenous fluid
ICD-10 code
E86.0
ICD-10 code description
Dehydration
Primary outcomes
1
Description
in hospital death
Timepoint
discharge time
Method of measurement
based on hospital record
2
Description
duration of hospitalization
Timepoint
at the end of hospitalization
Method of measurement
based on hospital record
3
Description
creatinine clearance
Timepoint
6 and 24 hours after initiation of IV fluid
Method of measurement
creatinine clearance estimated by the Cockcroft-Gault equation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Normal Saline group: patients in this group receive normal saline. volume and speed of fluid will be prescribed by responsible physician that is not dependent of type of crystaloid. name of patient and time of infusion will be recorded on fluid pocket label by nurse. observer will assess all pockets after usage about volume and time of infusion and will record it.
Category
Treatment - Drugs
2
Description
Intervention group: Lactated Ringer group: patients in this group receive normal saline. volume and speed of fluid will be prescribed by responsible physician that is not dependent of type of crystaloid. name of patient and time of infusion will be recorded on fluid pocket label by nurse. observer will assess all pockets after usage about volume and time of infusion and will record it.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Ali Aliee
Street address
end of Parastar Blvd, Kermanshah, Iran
City
kermanshah
Province
Kermanshah
Postal code
6742775333
Phone
+98 83 3427 6301
Fax
+98 83 3427 6300
Email
ali.aliee@kums.ac.ir
Web page address
http://imamreza.kums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
building No 2, Kermanshah University of Medical Sciences, Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3837 0541
Fax
+98 83 3838 6835
Email
farid_n32@yahoo.om
Web page address
http://vc-research.kums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Ali Aliee
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Unit 8, Arian Building, No 65, Hajdayi alley, Golestan, Kermanshah, Iran
City
kermanshah
Province
Kermanshah
Postal code
6714638381
Phone
+98 83 3825 2948
Email
alialiee@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ali Aliee
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Unit 8, Arian Building, No 65, Hajdayi alley, Golestan, Kermanshah, Iran
City
kermanshah
Province
Kermanshah
Postal code
6714638381
Phone
+98 83 3825 2948
Email
alialiee@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ali Aliee
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Unit 8, Arian Building, No 65, Hajdayi alley, Golestan, Kermanshah, Iran
City
kermanshah
Province
Kermanshah
Postal code
6714638381
Phone
+98 83 3825 2948
Email
alialiee@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