Correlation of Cardiac Output Determined by Echocardiography and Indirect Calorimetry in Critically Ill Patients in Cardiogenic Shock on Extracorporeal Circulatory Life Support

NCT06369818 | Recruiting

• 1 other identifier: AnIt23-02
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiogenic Shock

Keywords

Indirect calorimetry; cardiac output; Cardiopulmonary bypass (CBP); Extracorporal circulation (ECLS); Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Correlation of t two methods of determining cardiac output (determined by transthoracic echocardiography and determined by indirect calorimetry

  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.

  On the day of admission to the intensive care unit and immediately before ECLS explantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients of a university hospital

You may qualify if:

• Patients that received cardiac surgery
• Perioperative requirement of extracorporeal life support (ECLS)
• Age ≥ 18 years
• Informed consent

You may not qualify if:

• Pregnancy or breastfeeding
• Relationship or dependency with the study sponsor
• Expected survival less than 72 hours after screening

Sponsors & Collaborators

• Universität Münster: lead

Study Sites (1)

University Hospital Münster

Münster, 48149, Germany

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Christian Ertmer, MD

  University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Ertmer, MD

CONTACT

+49-251-8347255; christian.ertmer@ukmuenster.de

Thilo von Groote, MD

CONTACT

+49-251-8347255

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 17, 2024
• Study Start: January 18, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 20, 2024

Record last verified: 2024-05

Locations

DE (1)