NCT06726668

Brief 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 fluid requirement in shocked traumatic patients.

Trial Health

63
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Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Mar 2025

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 Progress95%
Mar 2025Jun 2026

First Submitted

Initial submission to the registry

December 6, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 10, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

December 6, 2024

Last Update Submit

December 9, 2024

Conditions

Keywords

UsSubclavian veinShockTrauma

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 the first 24 hours of resuscitation

  • -To assess the role of ultrasonograghic SCV CI in rapidly detecting early shock stages.

    In the first 24 hours of resuscitation

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

ShockWounds and Injuries

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mohamed A Mohamed Abdelhameed, Resident

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed A Mohamed Abdelhameed, Resident

CONTACT

Fatma A Abdelal, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emergency medicine resident physician at Assiut University Hospitals

Study Record Dates

First Submitted

December 6, 2024

First Posted

December 10, 2024

Study Start

March 1, 2025

Primary Completion

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

December 10, 2024

Record last verified: 2024-12

Locations