Determination of the effect of two fluid therapy methodes with and without Lasix in crash injuries with lung contusion referred to Kerman Shahid Bahonar Hospital
Design
Clinical trial with control and intervention parallel groups, double blinded, randomized and phase 2 on 26 patients
Settings and conduct
This clinical trial includes patients aged 18-60 with crash injuries referred to Kerman Bahonar Hospital. After checking the inclusion and exclusion criteria, people will be divided into two groups, receiving crystalloids (normal saline) and crystalloids accompanied with furosemide (Lasix). The study design is double blinded, and participants as well as researchers are not aware of the allocation of the groups. The checklist of relevant variables will be completed for each patient at the beginning of the study and every three hours after receiving treatment for 48 hours.
Participants/Inclusion and exclusion criteria
Inclusion criteria: adult patients (over 18 years old) with pulmonary contusion and Creatine Kinase values >5000 I/U due to multiple trauma present in the first six hours of trauma. Exclusion criteria: Myocardial contusion; organ failure; chronic pulmonary disease; pulmonary embolism; need for massive transfusion; complications of of blood transfusion; spinal cord injury; acute kidney injury; not willing to participate in the study; death within the first 48 hours.
Intervention groups
Control group: fluid therapy according to the defined protocol. Intervention group: fluid therapy according to the protocol with furosemide (2 mg/hour infusion ) added after three hours of fluid initiation.
Main outcome variables
Systolic blood pressure; diastolic blood pressure; mean arterial pressure; pulse rate; respiratory rate; arterial PaO2; serum sodium; creatine kinase; serum creatinin; intra-abdominal pressure; need for intubation; PaO2/FiO2 ratio; Intake/Output.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101220005426N14
Registration date:2023-03-24, 1402/01/04
Registration timing:registered_while_recruiting
Last update:2023-03-24, 1402/01/04
Update count:0
Registration date
2023-03-24, 1402/01/04
Registrant information
Name
Mehdi Ahmadinejad
Name of organization / entity
Anesthesiology department, Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 0223 5011
Email address
m.ahmadinejad@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two fluid therapy methods with and without Lasix in crash injuries with lung contusion referred to Kerman Bahonar Hospital in 2023
Public title
Comparison of two fluid therapy methods with and without Lasix in crash injuries with lung contusion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All adult patients (over 18 years old) with multiple trauma who were diagnosed with pulmonary contusion
Having creatine kinase (CPK) values over 5000 U/L
Non-invasive ventilation (NIV) due to hypoxia in the emergency department of Bahonar Hospital
Exclusion criteria:
Myocardial contusion
Organ failure
Chronic pulmonary disease
Pulmonary embolism
Need for massive transfusion
Complications of of blood transfusion
Spinal cord injury
Acute kidney injury
Not willing to participate in the study
Death within the first 48 hours
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method in such a way that blocks of size 4. Within each block, every position will be assigned to a number selected by the random numbers table, followed by defining the two positions with smaller numbers to the intervention and with the larger numbers to the control group. This process will be reversed in the next block.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double blinded study in which people will be divided into two control and intervention groups. Participants and data analyzers will not be not aware of the allocation of the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Kerman University of Medical Sciences
Street address
Vice chancellor for research, Kerman University of Medical Science, Jahad street
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2022-11-09, 1401/08/18
Ethics committee reference number
IR.KMU.AH.REC.1401.250
Health conditions studied
1
Description of health condition studied
Crush injuries
ICD-10 code
T14.7
ICD-10 code description
Crush injuries of unspecified body region
2
Description of health condition studied
Lung contusion
ICD-10 code
S27.32
ICD-10 code description
Contusion of lungs
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
At the beginning of the study and every hour after treatment up to 48 hours
Method of measurement
Sphygmomanometer
2
Description
Diastolic blood pressure
Timepoint
At the beginning of the study and every hour after treatment up to 48 hours
Method of measurement
Sphygmomanometer
3
Description
Mean arterial pressure
Timepoint
At the beginning of the study and every hour after treatment up to 48 hours
Method of measurement
It is calculated based on diastolic and systolic blood pressure
4
Description
Pulse rate
Timepoint
At the beginning of the study and every hour after the initiation of treatment up to 48 hours
Method of measurement
Pulse oximeter
5
Description
Respiratory rate
Timepoint
At the beginning of the study and every hour after the initiation of treatment up to 48 hours
Method of measurement
Counting over a minute
6
Description
Arterial partial Pressure of Oxygen (PaO2)
Timepoint
At the beginning of the study and every hour after the initiation of treatment up to 48 hours
Method of measurement
Blood gas analyzer
7
Description
Serum sodium
Timepoint
At the beginning of the study and every 6 hours after the initiation of treatment up to 48 hours
Method of measurement
AutoAnalyzer
8
Description
Oxygen saturation (SaO2)
Timepoint
At the beginning of the study and every hour after the initiation of treatment up to 48 hours
Method of measurement
Pulse oximeter
9
Description
Creatine kinase
Timepoint
At the beginning of the study and every hour after the initiation of treatment up to 48 hours
Method of measurement
AutoAnalyzer
10
Description
Serum creatinine level
Timepoint
At the beginning of the study and every hour after the initiation of treatment up to 48 hours
Method of measurement
AutoAnalyzer
11
Description
Intake/output
Timepoint
At the beginning of the study and every 6 hours after the initiation of treatment up to 48 hours
Method of measurement
Intake /output chart
12
Description
PaO2/FiO2 ratio
Timepoint
At the beginning of the study and every 6 hours after the initiation of treatment up to 48 hours
Method of measurement
Ventilator settings and ABG results
13
Description
Intra-abdominal pressure
Timepoint
At the beginning of the study and every 6 hours after the initiation of treatment up to 48 hours
Method of measurement
Foley catheter attached to a manual manometer
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Crystalloid infusion will be initiated for the patients as a one-liter bolus over 2 hours, followed by 6 liters per day until the patients be able to tolerate enteral feeding.
Category
Treatment - Other
2
Description
Intervention group: The volume and pace of infusion in this group will be the same as the control group. However, at the end of hour 3 after the initiation of fluid therapy, 40 mg of furosemide (20mg/2ml, Caspian Inc., IRAN) will be injected as a bolus which will be followed by an infusion of 2mg/hour by an infusion pump.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid bahonar hospital of kerman
Full name of responsible person
Mehdi Ahmadinejad
Street address
Shahid bahonar hospital - Qorani St - Valiasr Crossroad
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
m.ahmadinejad@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Reza Malekpour Afshar
Street address
Vice chancellor for research, Kerman University of Medical Science, Jahad street
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3719
Email
KMU_RESEARCH@YAHOO.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?