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Not yet recruitingNCT07255456Updated Dec 1, 2025

Correlation Between Inferior Vena Cava Collapsibility Index and Serum Lactate in Poly-trauma Patients

An observational study in Polytrauma Patients, sponsored by Farid Esmael Haridy Mohamed. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-12-01.

Sponsored by Farid Esmael Haridy Mohamed · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
126
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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.

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.

02

Conditions studied

  • Polytrauma Patients

Keywords

  • IVC-CI Lactate polytrauma
03

In context

Lead sponsor

This is the only study on the registry with Farid Esmael Haridy Mohamed as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • ▪ 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.

Exclusion criteria

Exclusion Criteria:

  • ▪ 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.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
126 participants (estimated)
Patient registry
No

Interventions

  • OtherAbdominal ultrasound and Serum Lactate Level

    Observational study there's no intervention

    Also known as: Abdominal ultrasound, ABG device

06

What researchers measure

Primary outcomes

  1. Positive correlation between IVC-CI and serum lactate level

    Time frame: At presentation

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — No individual participant data will be shared."

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07255456
Lead sponsor
Farid Esmael Haridy Mohamed
Collaborators
Assiut University
Responsible party
Farid Esmael Haridy Mohamed (Resident doctor at Emergency Department Assiut University, Assiut University) — Sponsor-investigator
First posted
Dec 1, 2025
Start date
Dec 1, 2025 (estimated)
Primary completion
Jun 1, 2028 (estimated)
Completion
Jul 1, 2028 (estimated)
Last update
Dec 1, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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