Prognostic Value of Exhaled Isoprene Levels for Morbidity and Functional Outcome in Cardiosurgical Patients

Frailty Clinical Trial

— PREDICT  

Official title:

Prognostic Value of Exhaled Isoprene Levels for Morbidity and Functional Outcome in Cardiosurgical Patients - A Single Center Prospective Observational Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06175429
• Other study ID #: PREDICT
• Status: Recruiting
• Start date: November 27, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: University of Rostock
• Contact: Felix Klawitter, Dr. med.
• Phone: +49381494146382
• Email: felix.klawitter[@]med.uni-rostock.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 31, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Muscle Weakness
• Volatile Organic Compounds

Intervention

Diagnostic Test:
• Physical performance testing
Assessment of physical performance using established clinical tests and scoring systems
• Breath sampling and VOC analysis
Sampling of exhaled breath and using Proton-transfer-reaction time-of-flight mass spectrometry (PTR-TOF) for VOC quantification.
• Muscle ultrasound
Quantitative and qualitative assessment of different limb skeletal muscles using non-invasive ultrasound.
• Blood-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)

Locations

Country	Name	City	State
Germany	Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, Rostock University Medical Center	Rostock	Mecklenburg-Vorpommern

Sponsors (4)

Lead Sponsor	Collaborator
University of Rostock	PD Dr. Johannes Ehler, Consultant, Department of Anesthesiology and Intensive Care Medicine, University Hospital Jena, Prof. Dr. Christian D. Etz, Head of Department, Department of Cardiac Surgery, Rostock University Medical Center, Prof. Dr. Daniel A. Reuter, Head of Department, Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, Rostock University Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Physical Performance Battery	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.	day 5 after surgery
Secondary	Cumulated Ambulation Score	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.	days 5 and 30 after surgery
Secondary	Morbidity	Assessment of the cumulative number of postoperative complications after surgery.	day 30 after surgery
Secondary	Isoprene concentration in patients with and without frailty	Comparison of exhaled isoprene levels (concentrations, part per billion volume - ppbV) measured by PTR-TOF between patients with and without physical frailty.	day 5 after surgery
Secondary	Medical Research Council Sum Score	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.	day 5 after surgery
Secondary	Muscle thickness	Assessment of muscle thickness (mm) using muscle ultrasound in eight different limb skeletal muscles.	day 5 after surgery
Secondary	Concentrations of blood-based biomarkers	Assessment of blood-based biomarker concentrations (pmol/l) of skeletal muscle integrity and metabolism.	day 5 after surgery