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.
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.
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: care cardio-pulmonary ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
Time of mortality occurrence since randomization, comparing intervention and control group.
Measured: 72 hours of the initial fluid resuscitation
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.
- First posted6 Mar 2024
- Study start1 Mar 2022
- Primary completion1 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ayman Hussein Fahmy, Professor, Study chair, Anesthesia, Intensive Care and Pain Management Department,Al-Azhar University, Faculty of medicine for boysMoaz Atef El-Shahat, Lecturer, Study director, Chest Diseases Department,Al-Azhar Faculty of MedicineHani Abdelshafook, Lecturer, Principal investigator, Cardiology Department, Al-Azhar Faculty of Medicine
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Integrated Cardiopulmonary Ultrasound on Clinical Outcome of Shocked Patients in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06295445
- Acronym / sponsor ID
- Cardiopulmonary Ultrasound
- Conditions
- Shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Control group | Experimental | Other: treatment without any use of point of care cardio-pulmonary ultrasound scans for guidance of the managementAbout 54 patients that will undergo treatment without any use of point of care cardio-pulmonary ultrasound scans for guidance of the management. |
| Group B: Study group | Experimental | Procedure: care cardio-pulmonary ultrasoundAbout 54 patients that will undergo cardio-pulmonary ultrasound guided management. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 .
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| care cardio-pulmonary ultrasoundAlso: EchoEvaluation 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 | Procedure or surgery | Group B: Study group |
| treatment without any use of point of care cardio-pulmonary ultrasound scans for guidance of the managementtreatment without any use of point of care cardio-pulmonary ultrasound scans for guidance of the management | Other | Group A: Control group |
Primary outcome
Mortality rate
Time frame: 72 hours of the initial fluid resuscitation
Time of mortality occurrence since randomization, comparing intervention and control group.
Number of mortalities
Time frame: 72 hours of the initial fluid resuscitation
Amount of non-survivor subject, comparing intervention and control group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayman Hussein Fahmy, Professor study chair
Anesthesia, Intensive Care and Pain Management Department,Al-Azhar University, Faculty of medicine for boys
Moaz Atef El-Shahat, Lecturer study director
Chest Diseases Department,Al-Azhar Faculty of Medicine
Hani Abdelshafook, Lecturer principal investigator
Cardiology Department, Al-Azhar Faculty of Medicine
1 site in 1 country: see every site and its status.
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.