Evaluating exhaled isoprene levels in cardiac surgery patients
Prognostic Value of Exhaled Isoprene Levels for Morbidity and Functional Outcome in Cardiosurgical Patients - A Single Center Prospective Observational Cohort Study
University of Rostock · NCT06175429
This study is testing if measuring a chemical in the breath can help doctors understand how well older patients will recover after heart surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 66 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Rostock (other) |
| Locations | 1 site (Rostock, Mecklenburg-Vorpommern) |
| Trial ID | NCT06175429 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the prognostic value of exhaled isoprene as a biomarker for skeletal muscle integrity and functional outcomes in patients aged 65 and older undergoing cardiac surgery. Participants will undergo comprehensive clinical evaluations, breath analysis, and muscle ultrasound before, during, and after surgery. The study hypothesizes that isoprene levels correlate with postoperative physical performance and morbidity, and differ between frail and non-frail patients. By identifying high-risk individuals early, appropriate preventive measures can be initiated to improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 65 and older who are scheduled for planned cardiac surgery lasting more than 60 minutes.
Not a fit: Patients who may not benefit include those with acute myocardial infarction, severe chronic illnesses, or those undergoing emergency surgery.
Why it matters
Potential benefit: If successful, this study could lead to improved identification and management of frail patients undergoing cardiac surgery, enhancing their postoperative recovery and quality of life.
How similar studies have performed: While the use of volatile organic compounds as biomarkers is a growing field, the specific application of exhaled isoprene in this context has not been extensively tested, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>= 65 years * planned cardiac surgery * operation duration \>60 min Exclusion Criteria: * refusal of study participation * emergency / urgent surgery * acute myocardial infarction * acute or chronic infection * Pre-existing illness with permanent restriction of mobility * Pre-existing neuromuscular disease * current malignant disease * terminal renal insufficiency * severe liver cirrhosis * severe obstructive pulmonary disease
Where this trial is running
Rostock, Mecklenburg-Vorpommern
- Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, Rostock University Medical Center — Rostock, Mecklenburg-Vorpommern, Germany (RECRUITING)
Study contacts
- Principal investigator: Felix Klawitter, Dr. med. — Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, Rostock University Medical Center
- Study coordinator: Felix Klawitter, Dr. med.
- Email: felix.klawitter@med.uni-rostock.de
- Phone: +49381494146382
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.
Conditions: Frailty, Muscle Weakness, Volatile Organic Compounds, Isoprene