Clinical trial NCT06175429: Prognostic Value of Exhaled Isoprene Levels for Morbidity and Functional Outcome in Cardiosurgical Patients
Official title: Prognostic Value of Exhaled Isoprene Levels for Morbidity and Functional Outcome in Cardiosurgical Patients - A Single Center Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Frailty
Muscle Weakness
Volatile Organic Compounds
Isoprene
Lead sponsor: University of Rostock
Sponsor class: OTHER
Collaborators: name: Prof. Dr. Daniel A. Reuter, Head of Department, Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, Rostock University Medical Center
name: Prof. Dr. Christian D. Etz, Head of Department, Department of Cardiac Surgery, Rostock University Medical Center
name: PD Dr. Johannes Ehler, Consultant, Department of Anesthesiology and Intensive Care Medicine, University Hospital Jena
First posted: 2023-12-18
Enrollment: 66
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective cardiac surgery

Brief summary: The perioperative preservation of functionality and quality of life plays an increasingly important role in older physically limited and frail patients undergoing cardiac surgery. Hereby, impairments of the skeletal muscle system integrity often contributes to a reduced physical performance. Early identification of these high-risk patients could help to initiate appropriate preventive and therapeutic measures. Volatile organic compounds (VOC) represent a non-invasive and real-time measurable approach for recording physiological and pathophysiological processes. Isoprene (2-methyl-1,3-butadiene) is one of the most abundantly exhaled VOCs and has recently been shown to originate from skeletal muscle metabolism. However, the prognostic value of isoprene as a volatile biomarker for skeletal muscle integrity, physical performance and functional outcome in patients undergoing cardiac surgery has not been evaluated before.

Detailed description: This is a single center prospective observational study evaluating exhaled isoprene as a perioperative volatile biomarker of skeletal muscle integrity, physical performance and functional outcome in cardiosurgical patients. All study participants will be assessed by comprehensive clinical examinations, laboratory testing, breath analysis and skeletal muscle ultrasound before, during as well as five and thirty days after surgery. Clinical assessments will be performed using established clinical scores and scales (e.g. the Short Physical Performance Battery and the Fried Frailty Index). Laboratory testing comprises a broad panel of blood-based biomarkers of skeletal muscle integrity and metabolism.

The investigators hypothesize that:

* perioperative exhaled isoprene levels correlate with postoperative measures of physical performance, functional outcome and morbidity
* perioperative exhaled isoprene levels differ between patients with and without physical frailty
* perioperative exhaled isoprene levels correlate with sonographic and laboratory parameters of skeletal muscle integrity

Eligibility 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

Primary outcomes:
measure: Short Physical Performance Battery
timeFrame: day 5 after surgery
Secondary outcomes:
measure: Cumulated Ambulation Score
timeFrame: days 5 and 30 after surgery
measure: Morbidity
timeFrame: day 30 after surgery
measure: Isoprene concentration in patients with and without frailty
timeFrame: day 5 after surgery
measure: Medical Research Council Sum Score
timeFrame: day 5 after surgery
measure: Muscle thickness
timeFrame: day 5 after surgery
measure: Concentrations of blood-based biomarkers
timeFrame: day 5 after surgery
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, Rostock University Medical Center
state: Mecklenburg-Vorpommern
Study officials:
affiliation: Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, Rostock University Medical Center
name: Felix Klawitter, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: