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

NCT06175429 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 66

Last updated 2023-12-18

No results posted yet for this study

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.

Conditions

  • Frailty
  • Muscle Weakness
  • Volatile Organic Compounds
  • Isoprene

Interventions

DIAGNOSTIC_TEST

Physical performance testing

Assessment of physical performance using established clinical tests and scoring systems

DIAGNOSTIC_TEST

Breath sampling and VOC analysis

Sampling of exhaled breath and using Proton-transfer-reaction time-of-flight mass spectrometry (PTR-TOF) for VOC quantification.

DIAGNOSTIC_TEST

Muscle ultrasound

Quantitative and qualitative assessment of different limb skeletal muscles using non-invasive ultrasound.

DIAGNOSTIC_TEST

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)

Sponsors & Collaborators

  • Prof. Dr. Daniel A. Reuter, Head of Department, Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, Rostock University Medical Center

    collaborator UNKNOWN
  • Prof. Dr. Christian D. Etz, Head of Department, Department of Cardiac Surgery, Rostock University Medical Center

    collaborator UNKNOWN
  • PD Dr. Johannes Ehler, Consultant, Department of Anesthesiology and Intensive Care Medicine, University Hospital Jena

    collaborator UNKNOWN
  • University of Rostock

    lead OTHER

Principal Investigators

  • Felix Klawitter, Dr. med. · Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, Rostock University Medical Center

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-27
Primary Completion
2025-10-01
Completion
2025-12-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06175429 on ClinicalTrials.gov