ShockNCT06726668
Estimating Fluid Requirement in Shocked Traumatic Patients by US on SCV
An observational study of Shock and Trauma, run by Assiut University at 1 site in Egypt.
Trial summary
Research question Is the ultrasonographic SCV collapsability index effective in estimating fluid requirements in shocked traumatic Patients ? Purpose of the study To evaluate the effectiveness of ultrasonograghic SCV collapsibility index before and after the first hour of resuscitation in estimating the First 24 h of… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Total coverage sample of all traumatic patients who will be admitted to emergency department Assiut university who fulfill the inclusion criteria during study period of 12 months from 1st of March 2025 to 1st of March 2026.
Who may be able to join
- Traumatic patients who will come to emergency department at Assiut university Hospital between march 2025 to march 2026 and will be admitted after stabilization to the Inpatient ward or ICU
Who cannot join
- Patients or their Relatives refuse participation in the study.
- Patients who will be transferred to another hospital
- • Pregnant women.
- Age below 18 and more than 60.
- Failure of follow-up of any patient.
- Cardiopulmonary resuscitation on arrival.
- Contraindicating fluid challenges, such as cardiac insufficiency and Renal failure .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University
Asyut, 71515
Vice President of graduate studies of Assiut University., VP, +209922080150, Vp_grad@aun.edu.eg
Mohamed A Mohamed Abdelhameed, Resident, +201156140325, mohammed1331998@gmail.com
About this study
Official title: Evaluation of the Role of Ultrasonographic Subclavian Vein Collapsibility Index in Estimating Fluid Requirement in Shocked Traumatic Patients in Emergency Department at Assiut University Hospital
Research question Is the ultrasonographic SCV collapsability index effective in estimating fluid requirements in shocked traumatic Patients ?
Purpose of the study To evaluate the effectiveness of ultrasonograghic SCV collapsibility index before and after the first hour of resuscitation in estimating the First 24 h of fluid requirement in shocked traumatic patients.
Read the detailed description
Hypovolemic shock is a circulatory malfunction associated with inadequate tissue perfusion that leads to multi organ failure. Since it results from either blood Loss or extracellular fluid loss, quick onset hypovolemia is usually the cause. Blood loss-related hypovolemic shock is known as hemorrhagic shock. Hemorrhagic shock is typically the primary cause of shock in trauma victims, while numerous other conditions can also contribute to shock. Hemorrhage accounts for 30 to 40% of trauma-related deaths, of which 33 to 56% happen in the prehospital phase and over 40% happen in the first 24 h. This means that it can be lethal very quickly. Hematocrit levels, biochemical markers, physical examination results, and other conventional measures are used to identify hypovolemia, but are not precise markers or trustworthy since they can be deemed normal when the body's compensatory mechanisms kick in, which could cause delays in the identification of volume loss. While tachycardia is a symptom of acute fluid loss, its sensitivity and specificity are insufficient for diagnosis or monitoring because it can be altered by a variety of internal and external signals. As A central line is an invasive procedure with potential complications (venous thrombosis, infection, pneumothorax, arterial puncture) during or after the procedure and poor predictive value, measurement of CVP is not practically used in hypovolemic patients admitted to the emergency department (ED). Focused assessment with sonography for trauma (FAST) has shown to be an effective way to identify bleeding sites in trauma patients using sonography. FAST took an average of 4 min per patient and was used successfully as a primary screening procedure at the hospital's entrance for traumatized mass casual patients. However, it provides no information regarding the patient's hemodynamic status, blood loss, amount lost, or response to resuscitation. As such, we require techniques for early detection of hypovolemia and accurate follow-up. The use of ultrasonography in critical care has grown in recent years due to technological advancements. The SCV is widely acknowledged as a trustworthy metric for assessing hemodynamic conditions. When the body experiences volume loss, the compensatory vasoconstrictor reaction has little effect on the SCV diameter. The noninvasive quick diagnosis, and low cost of sonographic measurement Of SCV diameter make this method a valuable tool for determining fluid requirements and evaluating Volume status in critically ill patients.
- Keywords
- Us, Subclavian vein, Shock, Trauma
- Medical subject headings
- Shock, Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate and predict the fluid requirement using ultrasonograghic Sub Clavian vein collapsibility index before and after the first hour of resuscitation
In the first hour of resuscitation, the patients (unstable shocked) will be given 1 L of crystalloid solution for fluid resuscitation ( according to recent ATLS guidelines). If the patient is still unstable after 1 Liter of fluid or had ongoing blood loss, O- negative blood transfusion will be administered and type-specific blood Will be ordered and the trauma team activated massive transfusion protocol according to recent ATLS Guidelines even if normal hemoglobin.
The traumatic patients after 1 h of resuscitation were divided into two groups (SCV non -Repleted) and (SCV Repleted) group as (if thereis still an SCV diameter of < 7 mm after the first hour of resuscitation they are called (the SCV non -Repleted) group. And if the SCV diameter of ≥ 7 mm after the first hour of resuscitation) they are called the (SCV Repleted) group.
Measured: Before resuscitation and after 1 hour of resuscitation
Secondary outcomes (2)
To estimate and predict the First 24-h fluid requirement using repeated ultrasonograghic SCV collapsibility index.
In this study, it's predicted that after the first hour of resuscitation (the SCV non - Repleted) group needed more than 1-2 ml/kg/hour in the first24 hours (more than 2400 ml fluid), and the (SCV Repleted) group we predict that after the first hour of resuscitation, they will need the average 1-2 ml/kg/hr. (average 2400 ml fluid) or less in the first 24 h. Patients will be clinically assessed and managed as per the ABC protocol.
Measured: In the first 24 hours of resuscitation
-To assess the role of ultrasonograghic SCV CI in rapidly detecting early shock stages.
Traumatic patients will be considered shocked if they have signs of shock such as decreased blood pressure < 90/60 mmHg , heart rate > 100 b/m, cold clammy skin, capillary refill > 2 s and their shock index above0.9.
Measured: In the first 24 hours of resuscitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Mohamed Abdelhameed, Assiut University
- Investigators
- Mohamed A Mohamed Abdelhameed, Resident, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726668
- Sponsor's protocol ID
- US Subclavian vein Shock
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Ultrasonographic Subclavian Vein Collapsibility Index in Estimating Fluid Requirement in Shocked Traumatic Patients in Emergency Department at Assiut University Hospital
- ClinicalTrials.gov ID
- NCT06726668
- Acronym / sponsor ID
- US Subclavian vein Shock
- Keywords
- Us, Subclavian vein, Shock, Trauma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 10 Dec 2024 (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.
Research question Is the ultrasonographic SCV collapsability index effective in estimating fluid requirements in shocked traumatic Patients ?
Purpose of the study To evaluate the effectiveness of ultrasonograghic SCV collapsibility index before and after the first hour of resuscitation in estimating the First 24 h of fluid requirement in shocked traumatic patients.
Detailed description
Hypovolemic shock is a circulatory malfunction associated with inadequate tissue perfusion that leads to multi organ failure. Since it results from either blood Loss or extracellular fluid loss, quick onset hypovolemia is usually the cause. Blood loss-related hypovolemic shock is known as hemorrhagic shock. Hemorrhagic shock is typically the primary cause of shock in trauma victims, while numerous other conditions can also contribute to shock. Hemorrhage accounts for 30 to 40% of trauma-related deaths, of which 33 to 56% happen in the prehospital phase and over 40% happen in the first 24 h. This means that it can be lethal very quickly. Hematocrit levels, biochemical markers, physical examination results, and other conventional measures are used to identify hypovolemia, but are not precise markers or trustworthy since they can be deemed normal when the body's compensatory mechanisms kick in, which could cause delays in the identification of volume loss. While tachycardia is a symptom of acute fluid loss, its sensitivity and specificity are insufficient for diagnosis or monitoring because it can be altered by a variety of internal and external signals. As A central line is an invasive procedure with potential complications (venous thrombosis, infection, pneumothorax, arterial puncture) during or after the procedure and poor predictive value, measurement of CVP is not practically used in hypovolemic patients admitted to the emergency department (ED). Focused assessment with sonography for trauma (FAST) has shown to be an effective way to identify bleeding sites in trauma patients using sonography. FAST took an average of 4 min per patient and was used successfully as a primary screening procedure at the hospital's entrance for traumatized mass casual patients. However, it provides no information regarding the patient's hemodynamic status, blood loss, amount lost, or response to resuscitation. As such, we require techniques for early detection of hypovolemia and accurate follow-up. The use of ultrasonography in critical care has grown in recent years due to technological advancements. The SCV is widely acknowledged as a trustworthy metric for assessing hemodynamic conditions. When the body experiences volume loss, the compensatory vasoconstrictor reaction has little effect on the SCV diameter. The noninvasive quick diagnosis, and low cost of sonographic measurement Of SCV diameter make this method a valuable tool for determining fluid requirements and evaluating Volume status in critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Total coverage sample of all traumatic patients who will be admitted to emergency department Assiut university who fulfill the inclusion criteria during study period of 12 months from 1st of March 2025 to 1st of March 2026.
Key inclusion criteria (1 listed)
- Traumatic patients who will come to emergency department at Assiut university Hospital between march 2025 to march 2026 and will be admitted after stabilization to the Inpatient ward or ICU
Key exclusion criteria (7 listed)
- Patients or their Relatives refuse participation in the study.
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
To estimate and predict the fluid requirement using ultrasonograghic Sub Clavian vein collapsibility index before and after the first hour of resuscitation
Time frame: Before resuscitation and after 1 hour of resuscitation
In the first hour of resuscitation, the patients (unstable shocked) will be given 1 L of crystalloid solution for fluid resuscitation ( according to recent ATLS guidelines). If the patient is still unstable after 1 Liter of fluid or had ongoing blood loss, O- negative blood transfusion will be administered and type-specific blood Will be ordered and the trauma team activated massive transfusion protocol according to recent ATLS Guidelines even if normal hemoglobin. The traumatic patients after 1 h of resuscitation were divided into two groups (SCV non -Repleted) and (SCV Repleted) group as (if thereis still an SCV diameter of < 7 mm after the first hour of resuscitation they are called (the SCV non -Repleted) group. And if the SCV diameter of ≥ 7 mm after the first hour of resuscitation) they are called the (SCV Repleted) group.
2 secondary outcomes
To estimate and predict the First 24-h fluid requirement using repeated ultrasonograghic SCV collapsibility index.
Time frame: In the first 24 hours of resuscitation
-To assess the role of ultrasonograghic SCV CI in rapidly detecting early shock stages.
Time frame: In the first 24 hours of resuscitation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Mohamed A Mohamed Abdelhameed, Resident principal investigator
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 and Trauma, 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 7 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: opening soon, as of the sponsor's last update on 10 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed A Mohamed Abdelhameed, Resident (+201156140325, mohammed1331998@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate and predict the fluid requirement using ultrasonograghic Sub Clavian vein collapsibility index before and after the first hour of resuscitation (time frame: Before resuscitation and after 1 hour of resuscitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2024.