NCT07255456

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
23mo left

Started Dec 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Dec 2025Jul 2028

First Submitted

Initial submission to the registry

November 20, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

December 1, 2025

Status Verified

November 1, 2025

Enrollment Period

2.5 years

First QC Date

November 20, 2025

Last Update Submit

November 20, 2025

Conditions

Keywords

IVC-CI Lactate polytrauma

Outcome Measures

Primary Outcomes (1)

  • Positive correlation between IVC-CI and serum lactate level

    At presentation

Interventions

Observational study there's no intervention

Also known as: Abdominal ultrasound, ABG device

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • ▪ 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.

You may not qualify if:

  • ▪ 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident doctor at Emergency Department Assiut University

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 1, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

December 1, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

No individual participant data will be shared."

Locations