NCT06295445

Brief Summary

Shock is one of the most common conditions in the intensive care unit (ICU) affecting one-third of critically ill patients. It reduces oxygen and nutrition's perfusion to the solid organs and is closely associated with increased mortality. Most literature has described how hemodynamic monitoring could provide an effective way to identify underlying pathophysiological processes and guide appropriate therapy in shock patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

1.5 years

First QC Date

February 21, 2024

Last Update Submit

March 9, 2024

Conditions

Shock

Outcome Measures

Primary Outcomes (2)

  • Mortality rate

    Time of mortality occurrence since randomization, comparing intervention and control group.

    72 hours of the initial fluid resuscitation

  • Number of mortalities

    Amount of non-survivor subject, comparing intervention and control group.

    72 hours of the initial fluid resuscitation

Study Arms (2)

Group A: Control group

EXPERIMENTAL

About 54 patients that will undergo treatment without any use of point of care cardio-pulmonary ultrasound scans for guidance of the management.

Other: treatment without any use of point of care cardio-pulmonary ultrasound scans for guidance of the management

Group B: Study group

EXPERIMENTAL

About 54 patients that will undergo cardio-pulmonary ultrasound guided management.

Procedure: care cardio-pulmonary ultrasound

Interventions

care cardio-pulmonary ultrasoundPROCEDURE

Evaluation of the heart and lung conditions in shocked patients using focused cardio-pulmonary ultrasound for treatment guidance and their implication on the patient's outcome

Also known as: Echo
Group B: Study group
treatment without any use of point of care cardio-pulmonary ultrasound scans for guidance of the managementOTHER

treatment without any use of point of care cardio-pulmonary ultrasound scans for guidance of the management

Group A: Control group

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • state of hypotension represented by systolic BP \<90 mm Hg or mean arterial pressure (MAP) \<60 mmHg).
  • serum lactate level of ≥ 2 mmol/L
  • positive with at least one of the conditions below: Lactate level \>2mmol/L.
  • Capillary Refill Time \>4.5s; Urine output per hour \<0.5ml/kg; Clammy skin, limbs cold. unconsciousness. initiation of intravenous vasopressors .

You may not qualify if:

  • Patients with trauma history,
  • Patients with suspected or diagnosed raised intra-abdominal or intrathoracic pressures as pregnancy, Portal hypertension, Mediastinal mass, Intracerebral hemorrhage, Increased intracranial pressure, Valvular heart disease,Atrial fibrillation.
  • Patients or families refused to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Shock

Interventions

CavesTherapeutics

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Geological PhenomenaPhysical PhenomenaEnvironmentEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Study Officials

  • Ayman Hussein Fahmy, Professor

    Anesthesia, Intensive Care and Pain Management Department,Al-Azhar University, Faculty of medicine for boys

    STUDY CHAIR

  • Moaz Atef El-Shahat, Lecturer

    Chest Diseases Department,Al-Azhar Faculty of Medicine

    STUDY DIRECTOR

  • Hani Abdelshafook, Lecturer

    Cardiology Department, Al-Azhar Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2024

First Posted

March 6, 2024

Study Start

March 1, 2022

Primary Completion

September 1, 2023

Study Completion

September 15, 2023

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)