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

NCT ID: NCT06175429

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-27

Study Completion Date

2025-12-31

Brief Summary

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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

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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

Conditions

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Frailty Muscle Weakness Volatile Organic Compounds Isoprene

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac surgery

Patients undergoing elective cardiac surgery

Physical performance testing

Intervention Type DIAGNOSTIC_TEST

Assessment of physical performance using established clinical tests and scoring systems

Breath sampling and VOC analysis

Intervention Type DIAGNOSTIC_TEST

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

Muscle ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Blood-based biomarker analysis

Intervention Type DIAGNOSTIC_TEST

Blood sampling and assessment of different blood-based biomarkers of muscle integrity using Enzyme-linked Immunosorbent Assay (ELISA) and Electrochemiluminescence Immunoassay (ECLIA)

Interventions

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Physical performance testing

Assessment of physical performance using established clinical tests and scoring systems

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Muscle ultrasound

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

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

UNKNOWN

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

University of Rostock

OTHER

Sponsor Role lead

Responsible Party

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Felix Klawitter, MD

Dr. med. Felix Klawitter, DESAIC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Felix Klawitter, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, Rostock University Medical Center

Locations

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Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, Rostock University Medical Center

Rostock, Mecklenburg-Vorpommern, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Felix Klawitter, Dr. med.

Role: CONTACT

Phone: +49381494146382

Email: [email protected]

Facility Contacts

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Felix Klawitter, Dr. med.

Role: primary

Other Identifiers

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PREDICT

Identifier Type: -

Identifier Source: org_study_id