ShockNCT05738265
Fluid Resuscitation In Trauma: What Are The Best Strategies And Fluids?
An observational study of Shock, run by Assiut University at 1 site in Egypt.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Shock
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 1 Oct 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- Child, Adult
Study population: Impact of resuscitation fluid (crystalloid,colloids) on shocked patients
Who may be able to join
- The present study will be conducted on shocked patients with multiple trauma of both genders and had 12 years old or more.
Who cannot join
- patients who are less than 12 years old,haemodynamically stable or with end stage chronic disease . Furthermore ,patients refusing study will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Shock
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Haemodynamic stability
Make the shocked patient haemodynamically stable , systolic blood pressure >90
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Aug 2022
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Ragab Ali Ismail, Assiut University
- Investigators
- Mohamed Abdelatif, Principal investigator, Assiut UniversityAsmaa Elkafafy, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738265
- Sponsor's protocol ID
- FRIT
- Status last verified
- Feb 2023
- First submitted
- 1 Feb 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
- Individual data sharing
- No: Not decided till now
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.
PubMed 20950434Shackford 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.
PubMed 8489391
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Resuscitation In Trauma: What Are The Best Strategies And Fluids?
- ClinicalTrials.gov ID
- NCT05738265
- Acronym / sponsor ID
- FRIT
- Conditions
- Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Impact of resuscitation fluid (crystalloid,colloids) on shocked patients
Key inclusion criteria (1 listed)
- The present study will be conducted on shocked patients with multiple trauma of both genders and had 12 years old or more.
Key exclusion criteria (1 listed)
- patients who are less than 12 years old,haemodynamically stable or with end stage chronic disease . Furthermore ,patients refusing study will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Haemodynamic stability
Time frame: 1day
Make the shocked patient haemodynamically stable , systolic blood pressure >90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Results publication: PubMed 20950434Finfer 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.
- Results publication: PubMed 8489391Shackford 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.
- Individual participant dataSharing planned: No. Not decided till now
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Abdelatif principal investigator
Assiut University
Asmaa Elkafafy principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemodynamic stability (time frame: 1day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05738265, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.