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ShockNCT06295445

Impact of Integrated Cardiopulmonary Ultrasound on Clinical Outcome of Shocked Patients in Intensive Care Unit

A study testing care cardio-pulmonary ultrasound and treatment without any use of point of care cardio-pulmonary ultrasound scans for guidance of the management in people with Shock, run by Egymedicalpedia at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 50 years
Conditions the study is for
Shock
What is being tested?
care cardio-pulmonary ultrasound and treatment without any use of point of care cardio-pulmonary ultrasound scans for guidance of the management
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteEgypt
Study dates
1 Mar 2022to 15 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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 .

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Al-Azhar University hospitals

    Cairo

Other trials in Egypt

About this study

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.

Read the detailed description

The diagnosis of shock is based on clinical, hemodynamic, and biochemical signs. It is manifested with systemic arterial hypotension with mean arterial pressure less than 70 mm Hg, with reflex tachycardia. Also, there are clinical signs of tissue hypoperfusion, including cutaneous hypoperfusion with cold clammy skin, renal hypoperfusion with resulting oliguria (urine output [UOP] <0.5 ml/kg/h) and neurologic hypoperfusion with altered mental state. Tissue hypoperfusion leads to anaerobic tissue metabolism with hyperlactatemia (>1.5 mmol/L).

Assessment of hemodynamic status and lines of management of the acute circulatory shock remains a challenging issue in emergency medicine and critical care. As the use of invasive hemodynamic monitoring declines, bedside-focused ultrasound (US) has become a valuable tool in the evaluation and management of patients in shock.

Four types of shock exist, including hypovolemic, cardiogenic, distributive, and obstructive shock. Clinical assessment and classification of shock is extremely difficult in critically ill patients as there is sometimes an overlap between these types. Incorporation of bedside ultrasound in patients with undifferentiated shock allows for rapid evaluation of reversible causes of shock and improves accurate diagnosis in undifferentiated hypotension.

Currently, the critical care ultrasound (CCUS) has been widely advocated as the preferred tool to assess hemodynamics, including accurately estimating pathophysiological changes of shock. This information, therefore, can be carried out into protocols to guide shock treatment. However, despite previous recommendations, current protocols are subjective and empirical, without listing specific variables as indicators, such as ejection fraction (EF), mitral annular plane systolic excursion (MAPSE), tricuspid annular plane systolic excursion (TAPSE),mitral or tricuspid annular peak systolic velocity (S'-MV or S'-TV), inferior vena cava (IVC), and lung ultrasound score (LUSS).

CCUS examination on ICU admission which performed by the experienced physician provide valuable information to assist the caregivers in understanding the comprehensive outlook of the characteristics of hemodynamics and lung pathology. Those key variables obtained by CCUS predict the possible prognosis of patients, hence deserve more attention in clinical decision making.

Lung ultrasound has been widely used in diagnosing pulmonary diseases including pneumonia, connective tissue diseases and interstitial lung diseases. For patients in the intensive care unit (ICU), more attention is paid to monitoring the development of lung pathologic changes, which guides the therapy. Lung insults caused by inflammation, trauma or water increase always lead to infiltration, which results in the loss of lung air. Depending on the severity of the aeration loss and water increase, each part of the lung generates different ultrasound signs upon exam.

The lung ultrasound score (LUSS) is the sum of the scores of each exam zone and has been justified as a respectable semiquantitative score to measure the lung aeration loss caused by different lung pathologic changes, such as pneumonia, atelectasis, pleural effusion, and lung edema.

Lung Ultrasound Protocol (LUSS): Reliable techniques have been used based on the international evidence-based recommendations for point-of-care lung ultrasound that recommended using a complete eight-zone lung ultrasound examination to evaluate the LUSS. The anterior and lateral chest wall are divided into eight areas. Areas 1 and 2 denote the upper anterior and lower anterior chest areas, respectively, and areas 3 and 4 denote the upper lateral and basal lateral chest areas, respectively.

Conditions
Shock
Being tested
care cardio-pulmonary ultrasound, treatment without any use of point of care cardio-pulmonary ultrasound scans for guidance of the management
Medical subject headings
Shock

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • care cardio-pulmonary ultrasoundProcedure or surgery

    Also called Echo

    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

  • 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

Study groups in NCT06295445
Study groupRoleWhat they receive
Group A: Control groupExperimentalAbout 54 patients that will undergo treatment without any use of point of care cardio-pulmonary ultrasound scans for guidance of the management.
Receives: Other: treatment without any use of point of care cardio-pulmonary ultrasound scans for guidance of the management
Group B: Study groupExperimentalAbout 54 patients that will undergo cardio-pulmonary ultrasound guided management.
Receives: Procedure: care cardio-pulmonary ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality rate

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

    Measured: 72 hours of the initial fluid resuscitation

  2. Number of mortalities

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

    Measured: 72 hours of the initial fluid resuscitation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2024
  2. Study start1 Mar 2022
  3. Primary completion1 Sep 2023
  4. Study completion15 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06295445
Sponsor's protocol ID
Cardiopulmonary Ultrasound
Status last verified
Mar 2024
First submitted
21 Feb 2024
Last updated
12 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing care cardio-pulmonary ultrasound and treatment without any use of point of care cardio-pulmonary ultrasound scans for guidance of the management in people with Shock, run by Egymedicalpedia at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality rate (time frame: 72 hours of the initial fluid resuscitation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.

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