NCT05488730

Brief Summary

fluid therapy is one of the cornerstones in the management of shock but may result in iatrogenic fluid overload .The aim of this study was to assess the role of echocardiography in guiding fluid therapy in shocked patients with impaired cardiac contractility using straight leg raising test ,Inferior vena-cava collapsability index and Doppler imaging in Emergency Department in Alexandria main university hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2022

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

12 months

First QC Date

August 3, 2022

Last Update Submit

August 13, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • LVOT VTI variability

    variability of LVOT VTI to determine fluid responsiveness

    15 minutes

Study Arms (1)

shocked patient with impaired cardiac contractility

OTHER
Diagnostic Test: passive leg raising test and fluid challenge

Interventions

Shocked patients were subjected to echocardiographic examination if (EF \<52%) .baseline LVOT VTI was obtained Then IVC scanning was done through subcostal Window and using M-mode the minimum and the maximum diameters were measured then the collapsibility index was calculated Then passive leg raising test was done Patients who tolerated the PLR test and did not develop clinical or lung ultrasound signs of fluid overload (lung congestion) were given IV fluid bolus (250 ml normal saline) over 10 minutes followed by measurement of LVOT VTI. Patients who did not tolerate PLR test or developed clinical or lung ultrasound signs of fluid overload (lung congestion) during PLR test were excluded from the third step (fluid challenge). The differentiating factor used to allocate patient in which group (non-responder or responder) was LVOT VTI variability after fluid challenge (our gold standard to assess fluid responsiveness).

shocked patient with impaired cardiac contractility

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • shocked patient with impaired cardiac contractility

You may not qualify if:

  • Trauma patients.
  • Patient with unstable arrhythmias.
  • Patients with lower limb amputation.
  • Mechanically ventilated patients.
  • Patients with prosthetic aortic valve.
  • Patients less than 18 years old
  • Pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Alexandria, Egypt

Location

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer of emergency medicine

Study Record Dates

First Submitted

August 3, 2022

First Posted

August 5, 2022

Study Start

August 1, 2021

Primary Completion

July 30, 2022

Study Completion

August 3, 2022

Last Updated

August 16, 2022

Record last verified: 2022-08

Locations