Heart problems that develop during an intensive care stay in critically ill adults
Intensive Care Unit-acquired Heart Failure in Critically Ill: the ICU-HF Study
This project uses bedside heart ultrasound and body composition measurements to see how often adults who need mechanical ventilation within 24 hours of ICU admission develop new heart dysfunction and muscle weakness.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 2 sites (Vienna, State of Vienna and 1 other locations) |
| Trial ID | NCT07094425 on ClinicalTrials.gov |
What this trial studies
This observational study enrolls critically ill adults who start mechanical ventilation within 24 hours of ICU admission and are expected to remain in the ICU for at least three days. Participants receive transthoracic echocardiography and body-muscle assessments during their ICU stay to document cardiac function and muscle mass/strength. The goal is to describe how often and when heart dysfunction and Intensive Care Unit–acquired weakness occur, and how these problems relate to each other and to short-term outcomes. The work is conducted at Charité – Universitätsmedizin Berlin and the Medical University of Vienna and does not test an experimental treatment.
Who should consider this trial
Good fit: Adults (≥18 years) admitted to participating ICUs who require mechanical ventilation within 24 hours of admission and are expected to stay in the ICU at least three days are ideal candidates.
Not a fit: Patients who are expected to die during the ICU stay, are transitioning to comfort-only care, have contraindications to the measurements (e.g., pacemaker, severe aortic stenosis, skin conditions preventing ultrasound), or for whom ultrasound is not technically feasible are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help clinicians recognize ICU-related heart dysfunction earlier and guide monitoring or supportive care to reduce long-term disability and mortality.
How similar studies have performed: Previous research has documented ICU-acquired muscle wasting and separate reports have noted cardiac dysfunction after critical illness, but systematically pairing serial bedside echocardiography with muscle assessments to define ICU-acquired heart failure is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Critically ill patients aged ≥ 18 years * Initiation of mechanical ventilation within the first 24 hours after ICU admission * Expected duration of ICU stay of at least 3 days Exclusion Criteria: * Language barriers * Expected death during ICU stay or planned transition to best supportive care * Known allergy to electrode gel * Ultrasound not technically feasible (e.g., due to extensive wounds, skin rash, or dressings) * Patients with a pacemaker or similar electronic devices for whom bioelectrical impedance analysis (BIA) is contraindicated * Patients with severe aortic valve stenosis
Where this trial is running
Vienna, State of Vienna and 1 other locations
- Medical University of Vienna — Vienna, State of Vienna, Austria (Recruiting)
- Charité - Universitätsmedizin Berlin — Berlin, State of Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Stefan J Schaller, MD — Charite University, Berlin, Germany
- Study coordinator: Stefan J Schaller, MD
- Email: stefan.schaller@charite.de
- Phone: +49 30 450 631289
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.