Polytrauma PatientsNCT07255456
Correlation Between Inferior Vena Cava Collapsibility Index and Serum Lactate in Poly-trauma Patients
An observational study of Polytrauma Patients, run by Farid Esmael Haridy Mohamed at 1 site in Egypt.
Trial summary
Polytrauma is defined as the presence of multiple traumatic injuries that may cause systemic physiological derangements and life-threatening conditions. Hypovolemia from blood loss is a major cause of death in polytrauma patients, and traditional methods of volume assessment like blood pressure and heart rate are… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Polytrauma Patients
- What is being tested?
- Abdominal ultrasound and Serum Lactate Level
- How many people
- 126 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 1 Jul 2028
- 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: The study population will consist of adult patients (≥18 years) presenting to the emergency department with polytrauma. Patients must be hemodynamically stable enough to undergo bedside ultrasound assessment of the inferior vena cava.
Who may be able to join
- ▪ Adult patients, both sex from 18 to 60 years old presented to the ED with blunt or penetrating polytrauma.
- Polytrauma according ATLS defined as simultaneous injuries to at least two body systems, with at least one of the injuries being life-threatening or typically refers to patients with a high Injury Severity Score (ISS) of 16 or greater.
- Hemodynamically stable or unstable at the time of admission.
- Informed consent obtained from patient or next of kin.
Who cannot join
- ▪ Any polytrauma patient presented with cardiogenic or obstructive shock.
- Patient is known to be cardiac that influence venous return.
- Renal failure.
- Chronic liver disease.
- Pregnancy.
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
Assiut- Elgamaa street, +201040126889, Faridesmael1997@gmail.com
About this study
Official title: Correlation Between Inferior Vena Cava Collapsibility Index and Serum Lactate in Poly-trauma Patients in Emergency Unite
Polytrauma is defined as the presence of multiple traumatic injuries that may cause systemic physiological derangements and life-threatening conditions. Hypovolemia from blood loss is a major cause of death in polytrauma patients, and traditional methods of volume assessment like blood pressure and heart rate are frequently late indicators and may be deceptive due to compensatory mechanisms. Early identification of these causes is essential for prompt intervention.The non-invasive ultrasound-based Inferior Vena Cava Collapsibility Index (IVC-CI), which offers information on intravascular volume status, is one such tool. Variations in the IVC's width throughout the respiratory cycle are reflected in the IVC collapsibility index. A high degree of collapsibility in patients who are breathing on their own usually denotes low central venous pressure and potential hypovolemia. The use of IVC measures as a stand-in for preload evaluation and fluid responsiveness has been validated by numerous studies, particularly in emergency and critical care situations.
The primary sources of lactate, the conjugate base of lactic acid, are red blood cells and muscles during anaerobic metabolism (when oxygen is limited). It is created when the enzyme lactate dehydrogenase (LDH) transforms pyruvate, the byproduct of glycolysis, into lactate; Serum lactate is a known indicator of tissue hypoperfusion and anaerobic metabolism, and elevated lactate levels are commonly seen in individuals with repeated injuries due to tissue hypoxia. Higher rates of morbidity, mortality, and extended hospitalizations in intensive care have all been linked to trauma patients with elevated lactate levels [3,4].
Read more
Given that both IVC-CI and serum lactate levels are reflective of hemodynamic compromise, exploring a potential correlation between them in polytrauma patients is clinically relevant. If a reliable relationship is established, bedside ultrasound of the IVC could serve as a fast, real-time indicator of systemic hypoperfusion, offering a complementary or even alternative assessment when laboratory lactate measurements are delayed or unavailable.
Additionally, because point-of-care ultrasound (POCUS) is quick, non-invasive, and repeatable, its use in trauma procedures has been growing. Because of this, emergency physicians who want to make quick but well-informed judgments during the critical period of trauma care will find the IVC-CI especially appealing [6]. Finding relationships between biochemical indicators such as lactate and ultrasonographic results may offer a more thorough method of patient assessment, facilitating more effective triage and resuscitation techniques. The purpose of this study is to look at the relationship between serum lactate levels and the Inferior Vena Cava Collapsibility Index in patients with polytrauma who arrive at the emergency room. Developing this connection could help improve prognostication in this high-risk population and optimize early resuscitation procedures.
Read the detailed description
Polytrauma is defined as the presence of multiple traumatic injuries that may cause systemic physiological. derangements and life-threatening conditions.
In US Polytrauma requiring major injury is estimated at around 54 cases per 1 million population per year and Overall in-hospital mortality among trauma discharges increased modestly from about 6.6% to 7.5% over the period of 1993-2012;in Egypt Trauma is estimated to account for ~8% of all deaths in Egypt, based on WHO estimates and national studies;in the Suez Canal University Hospital (Aug 2019-Mar 2020), trauma represented 5.3% of all emergency department cases, and among polytrauma cases: 44.4% were mild, 27.3% were life-threatening, Mortality was 56.0% for life-threatening cases and 6.9% for non-life-threatening polytrauma .In the Suez Canal University Hospital (Aug 2019-Mar 2020), trauma represented 5.3% of all emergency department cases, and among polytrauma cases 44.4% were mild, 27.3% were life-threatening ,mortality was 56.0% for life-threatening cases and 6.9% for non-life-threatening polytrauma . Assiut University, 2017 data): among 292 polytrauma patients, trauma-related mortality was around 20%.roughly half of deaths occurred early.
Hypovolemia from blood loss is a major cause of death in polytrauma patients, and traditional methods of volume assessment like blood pressure and heart rate are frequently late indicators and may be deceptive due to compensatory mechanisms. Early identification of these causes is essential for prompt intervention. As a result, there is increasing interest in using faster and more sensitive bedside instruments to direct resuscitation and track hemodynamic stability in trauma situations.
The non-invasive ultrasound-based Inferior Vena Cava Collapsibility Index (IVC-CI), which offers information on intravascular volume status, is one such tool. Variations in the IVC's width throughout the respiratory cycle are reflected in the IVC collapsibility index. A high degree of collapsibility in patients who are breathing on their own usually denotes low central venous pressure and potential hypovolemia. The use of IVC measures as a stand-in for preload evaluation and fluid responsiveness has been validated by numerous studies, particularly in emergency and critical care situations [1,2].
The primary sources of lactate, the conjugate base of lactic acid, are red blood cells and muscles during anaerobic metabolism (when oxygen is limited). It is created when the enzyme lactate dehydrogenase (LDH) transforms pyruvate, the byproduct of glycolysis, into lactate; Serum lactate is a known indicator of tissue hypoperfusion and anaerobic metabolism, and elevated lactate levels are commonly seen in individuals with repeated injuries due to tissue hypoxia. Higher rates of morbidity, mortality, and extended hospitalizations in intensive care have all been linked to trauma patients with elevated lactate levels [3,4].
Given that both IVC-CI and serum lactate levels are reflective of hemodynamic compromise, exploring a potential correlation between them in polytrauma patients is clinically relevant. If a reliable relationship is established, bedside ultrasound of the IVC could serve as a fast, real-time indicator of systemic hypoperfusion, offering a complementary or even alternative assessment when laboratory lactate measurements are delayed or unavailable.
Additionally, because point-of-care ultrasound (POCUS) is quick, non-invasive, and repeatable, its use in trauma procedures has been growing. Because of this, emergency physicians who want to make quick but well-informed judgments during the critical period of trauma care will find the IVC-CI especially appealing [6]. Finding relationships between biochemical indicators such as lactate and ultrasonographic results may offer a more thorough method of patient assessment, facilitating more effective triage and resuscitation techniques. The purpose of this study is to look at the relationship between serum lactate levels and the Inferior Vena Cava Collapsibility Index in patients with polytrauma who arrive at the emergency room. Developing this connection could help improve prognostication in this high-risk population and optimize early resuscitation procedures.
- Conditions
- Polytrauma Patients
- Being tested
- Abdominal ultrasound and Serum Lactate Level
- Keywords
- IVC-CI Lactate polytrauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal ultrasound and Serum Lactate LevelOther
Also called Abdominal ultrasound, ABG device
Observational study there's no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive correlation between IVC-CI and serum lactate level
Measured: At presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polytrauma PatientsStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Farid Esmael Haridy Mohamed
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Farid Esmael Haridy Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255456
- Sponsor's protocol ID
- IVC-CI & lactate in polytrauma
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared."
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Inferior Vena Cava Collapsibility Index and Serum Lactate in Poly-trauma Patients in Emergency Unite
- ClinicalTrials.gov ID
- NCT07255456
- Acronym / sponsor ID
- IVC-CI & lactate in polytrauma
- Conditions
- Polytrauma Patients
- Keywords
- IVC-CI Lactate polytrauma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Farid Esmael Haridy MohamedUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 1 Dec 2025 (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.
Polytrauma is defined as the presence of multiple traumatic injuries that may cause systemic physiological derangements and life-threatening conditions. Hypovolemia from blood loss is a major cause of death in polytrauma patients, and traditional methods of volume assessment like blood pressure and heart rate are frequently late indicators and may be deceptive due to compensatory mechanisms. Early identification of these causes is essential for prompt intervention.The non-invasive ultrasound-based Inferior Vena Cava Collapsibility Index (IVC-CI), which offers information on intravascular volume status, is one such tool. Variations in the IVC's width throughout the respiratory cycle are reflected in the IVC collapsibility index. A high degree of collapsibility in patients who are breathing on their own usually denotes low central venous pressure and potential hypovolemia. The use of IVC measures as a stand-in for preload evaluation and fluid responsiveness has been validated by numerous studies, particularly in emergency and critical care situations.
The primary sources of lactate, the conjugate base of lactic acid, are red blood cells and muscles during anaerobic metabolism (when oxygen is limited). It is created when the enzyme lactate dehydrogenase (LDH) transforms pyruvate, the byproduct of glycolysis, into lactate; Serum lactate is a known indicator of tissue hypoperfusion and anaerobic metabolism, and elevated lactate levels are commonly seen in individuals with repeated injuries due to tissue hypoxia. Higher rates of morbidity, mortality, and extended hospitalizations in intensive care have all been linked to trauma patients with elevated lactate levels [3,4].
Given that both IVC-CI and serum lactate levels are reflective of hemodynamic compromise, exploring a potential correlation between them in polytrauma patients is clinically relevant. If a reliable relationship is established, bedside ultrasound of the IVC could serve as a fast, real-time indicator of systemic hypoperfusion, offering a complementary or even alternative assessment when laboratory lactate measurements are delayed or unavailable.
Additionally, because point-of-care ultrasound (POCUS) is quick, non-invasive, and repeatable, its use in trauma procedures has been growing. Because of this, emergency physicians who want to make quick but well-informed judgments during the critical period of trauma care will find the IVC-CI especially appealing [6]. Finding relationships between biochemical indicators such as lactate and ultrasonographic results may offer a more thorough method of patient assessment, facilitating more effective triage and resuscitation techniques. The purpose of this study is to look at the relationship between serum lactate levels and the Inferior Vena Cava Collapsibility Index in patients with polytrauma who arrive at the emergency room. Developing this connection could help improve prognostication in this high-risk population and optimize early resuscitation procedures.
Detailed description
Polytrauma is defined as the presence of multiple traumatic injuries that may cause systemic physiological. derangements and life-threatening conditions.
In US Polytrauma requiring major injury is estimated at around 54 cases per 1 million population per year and Overall in-hospital mortality among trauma discharges increased modestly from about 6.6% to 7.5% over the period of 1993-2012;in Egypt Trauma is estimated to account for ~8% of all deaths in Egypt, based on WHO estimates and national studies;in the Suez Canal University Hospital (Aug 2019-Mar 2020), trauma represented 5.3% of all emergency department cases, and among polytrauma cases: 44.4% were mild, 27.3% were life-threatening, Mortality was 56.0% for life-threatening cases and 6.9% for non-life-threatening polytrauma .In the Suez Canal University Hospital (Aug 2019-Mar 2020), trauma represented 5.3% of all emergency department cases, and among polytrauma cases 44.4% were mild, 27.3% were life-threatening ,mortality was 56.0% for life-threatening cases and 6.9% for non-life-threatening polytrauma . Assiut University, 2017 data): among 292 polytrauma patients, trauma-related mortality was around 20%.roughly half of deaths occurred early.
Hypovolemia from blood loss is a major cause of death in polytrauma patients, and traditional methods of volume assessment like blood pressure and heart rate are frequently late indicators and may be deceptive due to compensatory mechanisms. Early identification of these causes is essential for prompt intervention. As a result, there is increasing interest in using faster and more sensitive bedside instruments to direct resuscitation and track hemodynamic stability in trauma situations.
The non-invasive ultrasound-based Inferior Vena Cava Collapsibility Index (IVC-CI), which offers information on intravascular volume status, is one such tool. Variations in the IVC's width throughout the respiratory cycle are reflected in the IVC collapsibility index. A high degree of collapsibility in patients who are breathing on their own usually denotes low central venous pressure and potential hypovolemia. The use of IVC measures as a stand-in for preload evaluation and fluid responsiveness has been validated by numerous studies, particularly in emergency and critical care situations [1,2].
The primary sources of lactate, the conjugate base of lactic acid, are red blood cells and muscles during anaerobic metabolism (when oxygen is limited). It is created when the enzyme lactate dehydrogenase (LDH) transforms pyruvate, the byproduct of glycolysis, into lactate; Serum lactate is a known indicator of tissue hypoperfusion and anaerobic metabolism, and elevated lactate levels are commonly seen in individuals with repeated injuries due to tissue hypoxia. Higher rates of morbidity, mortality, and extended hospitalizations in intensive care have all been linked to trauma patients with elevated lactate levels [3,4].
Given that both IVC-CI and serum lactate levels are reflective of hemodynamic compromise, exploring a potential correlation between them in polytrauma patients is clinically relevant. If a reliable relationship is established, bedside ultrasound of the IVC could serve as a fast, real-time indicator of systemic hypoperfusion, offering a complementary or even alternative assessment when laboratory lactate measurements are delayed or unavailable.
Additionally, because point-of-care ultrasound (POCUS) is quick, non-invasive, and repeatable, its use in trauma procedures has been growing. Because of this, emergency physicians who want to make quick but well-informed judgments during the critical period of trauma care will find the IVC-CI especially appealing [6]. Finding relationships between biochemical indicators such as lactate and ultrasonographic results may offer a more thorough method of patient assessment, facilitating more effective triage and resuscitation techniques. The purpose of this study is to look at the relationship between serum lactate levels and the Inferior Vena Cava Collapsibility Index in patients with polytrauma who arrive at the emergency room. Developing this connection could help improve prognostication in this high-risk population and optimize early resuscitation procedures.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will consist of adult patients (≥18 years) presenting to the emergency department with polytrauma. Patients must be hemodynamically stable enough to undergo bedside ultrasound assessment of the inferior vena cava.
Key inclusion criteria (4 listed)
- ▪ Adult patients, both sex from 18 to 60 years old presented to the ED with blunt or penetrating polytrauma.
- Polytrauma according ATLS defined as simultaneous injuries to at least two body systems, with at least one of the injuries being life-threatening or typically refers to patients with a high Injury Severity Score (ISS) of 16 or greater.
- Hemodynamically stable or unstable at the time of admission.
- Informed consent obtained from patient or next of kin.
Key exclusion criteria (5 listed)
- ▪ Any polytrauma patient presented with cardiogenic or obstructive shock.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal ultrasound and Serum Lactate LevelAlso: Abdominal ultrasound, ABG deviceObservational study there's no intervention | Other | – |
Primary outcome
Positive correlation between IVC-CI and serum lactate level
Time frame: At presentation
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 1 Dec 2025.
- Individual participant dataSharing planned: No. No individual participant data will be shared."
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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.
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 Polytrauma Patients, run by Farid Esmael Haridy Mohamed 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 4 inclusion and 5 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 1 Dec 2025. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive correlation between IVC-CI and serum lactate level (time frame: At presentation). 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 1 Dec 2025; AzTrials last refreshed its copy on 1 Nov 2026.