- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05738265
Fluid Resuscitation In Trauma: What Are The Best Strategies And Fluids?
February 11, 2023 updated by: Walaa Ragab Ali Ismail, Assiut University
Illustration of the differential effects of commonly used resuscitation fluids, including isotonic crystalloids, natural and artificial colloids, hypertonic and hyperoncotic solutions to prevent the cellular injury through wiser resuscitation in traumatic patient .
The ideal resuscitation strategy for multiply injured patients.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
The repletion of patients' intravascular volume through the use of an intravenous (IV) electrolyte solution was first described by a young Irish physician, William Brooke O'Shaughnessy, in 1831.
Immersing himself in the middle of a cholera outbreak in Sutherland, England, O'Shaughnessy observed that large amounts of water, sodium, chloride, and bicarbonate were being lost in these patients' stool.
With only brain injury as a larger cause of overall mortality, hemorrhage is the leading cause of preventable trauma death.
Rates of mortality in injured patients requiring a massive blood transfusion in the late 1980s were greater than 80%.
Prehospital strategies considered standard of care at the time included early intravenous (IV) access with 2 large-bore cannulas and aggressive administration of crystalloid, regardless of patient physiology.
Most hemorrhage-related deaths occur in the first 6 h after injury The most common reason given for administering resuscitation fluid was impaired tissue perfusion or low measured cardiac output.
The next most common indication, was abnormal vital signs (blood pressure, heart rate, urine output or central venous pressure) in the absence of evidence of impaired tissue perfusion Fluids have classically been categorized as crystalloid or colloid, terms introduced by Thomas Graham (Professor of Chemistry, University College London, 1836-1855) long before intravenous fluids were widely used in clinical practice.
The ideal fluids should provide a solution to the various components of the physiopathology of shock.
Two strategies were proposed to avoid clot disruption and dilutional coagulopathy: delayed resuscitation strategy where fluid is given after bleeding is controlled and permissive hypotension strategy, where fluid is given to increase in systolic blood pressure without reaching normotension.
In penetrating trauma patients with hypotension (prehospital Systolic blood pressure < 90 mmHg), delayed resuscitation shows better survival rates compared to immediate resuscitation THE BALANCED RESUSCITATION STRATEGY Ideally, this process begins in the prehospital setting, continues through early trauma bay/emergency room resuscitation, and is completed in the operating room or the ICU, as needed.
To improve outcomes of patients undergoing an abbreviated laparotomy or other procedure because of grossly disturbed physiology.
As an adjunct to the care of these critically injured patients, its early implementation focused on delivering higher ratios of plasma and platelets, along with other strategies to prevent "popping the clot."
Its 3 basic tenets are permissive hypotension, minimizing the use of crystalloid before surgical control of bleeding, and transfusion of blood products in a ratio approximating whole blood
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Assiut, Egypt
- Assiut University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Impact of resuscitation fluid (crystalloid,colloids) on shocked patients
Description
Inclusion Criteria:
- The present study will be conducted on shocked patients with multiple trauma of both genders and had 12 years old or more.
Exclusion Criteria:
- patients who are less than 12 years old,haemodynamically stable or with end stage chronic disease . Furthermore ,patients refusing study will be excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Shocked patients who take crystalloids
Impact of crystalloids on shocked patients in trauma
|
|
Shocked patients who take colloids
Impact of colloids on shocked patients in trauma
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Haemodynamic stability
Time Frame: 1day
|
Make the shocked patient haemodynamically stable , systolic blood pressure >90
|
1day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohamed Abdelatif, Assiut University
- Principal Investigator: Asmaa Elkafafy, Alexandria University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Finfer S, Liu B, Taylor C, Bellomo R, Billot L, Cook D, Du B, McArthur C, Myburgh J; SAFE TRIPS Investigators. Resuscitation fluid use in critically ill adults: an international cross-sectional study in 391 intensive care units. Crit Care. 2010;14(5):R185. doi: 10.1186/cc9293. Epub 2010 Oct 15.
- Shackford SR, Mackersie RC, Holbrook TL, Davis JW, Hollingsworth-Fridlund P, Hoyt DB, Wolf PL. The epidemiology of traumatic death. A population-based analysis. Arch Surg. 1993 May;128(5):571-5. doi: 10.1001/archsurg.1993.01420170107016.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2022
Primary Completion (Anticipated)
April 1, 2025
Study Completion (Anticipated)
October 1, 2025
Study Registration Dates
First Submitted
February 1, 2023
First Submitted That Met QC Criteria
February 11, 2023
First Posted (Estimate)
February 22, 2023
Study Record Updates
Last Update Posted (Estimate)
February 22, 2023
Last Update Submitted That Met QC Criteria
February 11, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- FRIT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Not decided till now
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.