Frailty, Isoprene, Muscle Weakness, Volatile Organic Compounds
Conditions
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
Interventions
DIAGNOSTIC_TESTMuscle ultrasound
Quantitative and qualitative assessment of different limb skeletal muscles using non-invasive ultrasound.
DIAGNOSTIC_TESTBlood-based biomarker analysis
Blood sampling and assessment of different blood-based biomarkers of muscle integrity using Enzyme-linked Immunosorbent Assay (ELISA) and Electrochemiluminescence Immunoassay (ECLIA)
DIAGNOSTIC_TESTPhysical performance testing
Assessment of physical performance using established clinical tests and scoring systems
DIAGNOSTIC_TESTBreath sampling and VOC analysis
Sampling of exhaled breath and using Proton-transfer-reaction time-of-flight mass spectrometry (PTR-TOF) for VOC quantification.
Sponsors
Prof. Dr. Daniel A. Reuter, Head of Department, Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, Rostock University Medical Center
Prof. Dr. Christian D. Etz, Head of Department, Department of Cardiac Surgery, Rostock University Medical Center
PD Dr. Johannes Ehler, Consultant, Department of Anesthesiology and Intensive Care Medicine, University Hospital Jena
University of Rostock
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Physical Performance Battery | day 5 after surgery | Assessment of patient's physical performance using the Short Physical Performance Battery (SPPB, Score, scales 0-12), whereby a higher SPPB corresponds to a better physical performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | day 30 after surgery | Assessment of the cumulative number of postoperative complications after surgery. |
| Isoprene concentration in patients with and without frailty | day 5 after surgery | Comparison of exhaled isoprene levels (concentrations, part per billion volume - ppbV) measured by PTR-TOF between patients with and without physical frailty. |
| Cumulated Ambulation Score | days 5 and 30 after surgery | Assessment of functional patient outcome using the Cumulated Ambulation Score (CAS, Score, scales 0-6), whereby a higher CAS corresponds to a better functional outcome. |
| Muscle thickness | day 5 after surgery | Assessment of muscle thickness (mm) using muscle ultrasound in eight different limb skeletal muscles. |
| Concentrations of blood-based biomarkers | day 5 after surgery | Assessment of blood-based biomarker concentrations (pmol/l) of skeletal muscle integrity and metabolism. |
| Medical Research Council Sum Score | day 5 after surgery | Assessment of general muscle strength of study participants using the Medical Research Council Sum Score (MRCSS, Score, scales 0-60), whereby a higher MRCSS corresponds to a higher muscle strength. |
Countries
Germany
Contacts
Primary ContactFelix Klawitter, Dr. med.
Outcome results
None listed