Cardiogenic ShockNCT06369818
Correlation of Cardiac Output Determined by Echocardiography and Indirect Calorimetry in Critically Ill Patients in Cardiogenic Shock on Extracorporeal Circulatory Life Support
An observational study of Cardiogenic Shock, run by Universität Münster at 1 site in Germany.
Trial summary
This observational study investigates whether the daily measured trend of cardiac output as evaluated by indirect calorimetry correlates with the same evaluated by transthoracic echocardiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jan 2024to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients of a university hospital
Who may be able to join
- Patients that received cardiac surgery
- Perioperative requirement of extracorporeal life support (ECLS)
- Age ≥ 18 years
- Informed consent
Who cannot join
- Pregnancy or breastfeeding
- Relationship or dependency with the study sponsor
- Expected survival less than 72 hours after screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thilo von Groote, MD contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital Münster
Münster, 48149
Thilo von Groote, MD, +49-251-47255
About this study
This observational study investigates whether the daily measured trend of cardiac output as evaluated by indirect calorimetry correlates with the same evaluated by transthoracic echocardiography.
Read the detailed description
Patients in perioperative cardiogenic shock often require hemodynamic support. If supportive therapy is not sufficient, the implementation of mechanical extracorporeal life support (ECLS) represents a rescue therapy. This procedure enables a "bridge-to-recovery" strategy, i.e. bridging the cardiogenic shock until the patient recovers. The ECLS uses a pump to support the circulation by drawing in blood through a venous cannula, oxygenating it extracorporeally and reinfusing it into the body under pressure through an arterial cannula. In addition to this share of cardiac output (CO) provided by the ECLS, the beating heart can also contribute part of the CO in cardiogenic shock. Following, blood flow generated by the ECLS system will be referred to as ECLS CO and blood flow generated by the heart as cardiac CO. In patients without ECLS, the total CO can be estimated and determined non-invasively using transthoracic echocardiography. In patients with ECLS, the cardiac CO is also determined by echocardiography in everyday clinical practice, even if the validity of this procedure in patients receiving ECLS therapy has not been conclusively established. Indirect calorimetry, which is routinely used to determine energy expenditure in critically ill patients, could be another method of estimating cardiac CO. However, the extent to which the results of indirect calorimetry and ultrasound-based cardiac CO correlate is unclear and has not yet been investigated. However, a correlation of sonographic and calorimetric findings would be helpful in everyday clinical practice, as in some patients it is not possible to determine the cardiac CO by sonography for technical reasons.
The daily measurement of resting energy expenditure (REE), oxygen consumption (VO2) and CO2 production (VCO2) is carried out using indirect calorimetry in patients with veno-arterial ECLS support to bridge cardiogenic shock after cardiac surgery. In these patients, the cardiac CO is regularly determined daily using transthoracic echocardiography. The measurements are taken daily until the second day after cessation of ECLS therapy. The parameters obtained on the day of admission to the intensive care unit and directly before ECLS explantation will then be correlated with each other and examined for a possible correlation. Further data obtained will be examined as part of exploratory evaluations.
- Conditions
- Cardiogenic Shock
- Keywords
- Indirect calorimetry, cardiac output, Cardiopulmonary bypass (CBP), Extracorporal circulation (ECLS), Cardiac Surgery
- Medical subject headings
- Shock, Cardiogenic
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of t two methods of determining cardiac output (determined by transthoracic echocardiography and determined by indirect calorimetry
- Transthoracic echocardiography.:For this purpose, the diameter of the left ventricular outflow tract (LVOT) is measured echocardiographically. Furthermore, the velocity-time integral (VTI) is determined echocardiographically as an approximation of the flow per heartbeat. If this VTI is multiplied by the cross section of the left ventricular outflow tract and the heart rate, the cardiac CO can be estimated.
- Indirect calorimetry. This is calculated as follows: Cardiac CO = (Calorimetry-VO2/ECLS-VO2)*ECLS Blood Flow. For this purpose, calorimetry VO2 is measured directly and ECLS VO2 is calculated using the avDO2 (ECLS O2 content of the arterial cannula minus venous cannula) multiplied by the ECLS blood flow. This shortens the ECLS blood flow. It remains: CO = calorimetry-VO2/avDO2-ECLS.
Measured: On the day of admission to the intensive care unit and immediately before ECLS explantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start18 Jan 2024
- Primary completionSep 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Münster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Ertmer, MD, Principal investigator, University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369818
- Sponsor's protocol ID
- AnIt23-02
- Status last verified
- May 2024
- First submitted
- 12 Apr 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Cardiac Output Determined by Echocardiography and Indirect Calorimetry in Critically Ill Patients in Cardiogenic Shock on Extracorporeal Circulatory Life Support
- ClinicalTrials.gov ID
- NCT06369818
- Acronym / sponsor ID
- AnIt23-02
- Conditions
- Cardiogenic Shock
- Keywords
- Indirect calorimetry, cardiac output, Cardiopulmonary bypass (CBP), Extracorporal circulation (ECLS), Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universität MünsterUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 17 Apr 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.
This observational study investigates whether the daily measured trend of cardiac output as evaluated by indirect calorimetry correlates with the same evaluated by transthoracic echocardiography.
Detailed description
Patients in perioperative cardiogenic shock often require hemodynamic support. If supportive therapy is not sufficient, the implementation of mechanical extracorporeal life support (ECLS) represents a rescue therapy. This procedure enables a "bridge-to-recovery" strategy, i.e. bridging the cardiogenic shock until the patient recovers. The ECLS uses a pump to support the circulation by drawing in blood through a venous cannula, oxygenating it extracorporeally and reinfusing it into the body under pressure through an arterial cannula. In addition to this share of cardiac output (CO) provided by the ECLS, the beating heart can also contribute part of the CO in cardiogenic shock. Following, blood flow generated by the ECLS system will be referred to as ECLS CO and blood flow generated by the heart as cardiac CO. In patients without ECLS, the total CO can be estimated and determined non-invasively using transthoracic echocardiography. In patients with ECLS, the cardiac CO is also determined by echocardiography in everyday clinical practice, even if the validity of this procedure in patients receiving ECLS therapy has not been conclusively established. Indirect calorimetry, which is routinely used to determine energy expenditure in critically ill patients, could be another method of estimating cardiac CO. However, the extent to which the results of indirect calorimetry and ultrasound-based cardiac CO correlate is unclear and has not yet been investigated. However, a correlation of sonographic and calorimetric findings would be helpful in everyday clinical practice, as in some patients it is not possible to determine the cardiac CO by sonography for technical reasons.
The daily measurement of resting energy expenditure (REE), oxygen consumption (VO2) and CO2 production (VCO2) is carried out using indirect calorimetry in patients with veno-arterial ECLS support to bridge cardiogenic shock after cardiac surgery. In these patients, the cardiac CO is regularly determined daily using transthoracic echocardiography. The measurements are taken daily until the second day after cessation of ECLS therapy. The parameters obtained on the day of admission to the intensive care unit and directly before ECLS explantation will then be correlated with each other and examined for a possible correlation. Further data obtained will be examined as part of exploratory evaluations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients of a university hospital
Key inclusion criteria (4 listed)
- Patients that received cardiac surgery
- Perioperative requirement of extracorporeal life support (ECLS)
- Age ≥ 18 years
- Informed consent
Key exclusion criteria (3 listed)
- Pregnancy or breastfeeding
- Relationship or dependency with the study sponsor
- Expected survival less than 72 hours after screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of t two methods of determining cardiac output (determined by transthoracic echocardiography and determined by indirect calorimetry
Time frame: On the day of admission to the intensive care unit and immediately before ECLS explantation
1. Transthoracic echocardiography.:For this purpose, the diameter of the left ventricular outflow tract (LVOT) is measured echocardiographically. Furthermore, the velocity-time integral (VTI) is determined echocardiographically as an approximation of the flow per heartbeat. If this VTI is multiplied by the cross section of the left ventricular outflow tract and the heart rate, the cardiac CO can be estimated. 2. Indirect calorimetry. This is calculated as follows: Cardiac CO = (Calorimetry-VO2/ECLS-VO2)*ECLS Blood Flow. For this purpose, calorimetry VO2 is measured directly and ECLS VO2 is calculated using the avDO2 (ECLS O2 content of the arterial cannula minus venous cannula) multiplied by the ECLS blood flow. This shortens the ECLS blood flow. It remains: CO = calorimetry-VO2/avDO2-ECLS.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
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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.
Thilo von Groote, MD contact
Christian Ertmer, MD principal investigator
University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock, run by Universität Münster at 1 site in Germany.
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: looking for participants now, as of the sponsor's last update on 20 May 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Ertmer, MD (+49-251-8347255, christian.ertmer@ukmuenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of t two methods of determining cardiac output (determined by transthoracic echocardiography and determined by indirect calorimetry (time frame: On the day of admission to the intensive care unit and immediately before ECLS explantation). 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 20 May 2024.