Prognostic Value of Exhaled Isoprene Levels for Morbidity and Functional Outcome in Cardiosurgical Patients
NCT ID: NCT06175429
Last Updated: 2023-12-18
Study Results
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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RECRUITING
66 participants
OBSERVATIONAL
2023-11-27
2025-12-31
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cardiac surgery
Patients undergoing elective cardiac surgery
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* planned cardiac surgery
* operation duration \>60 min
Exclusion Criteria
* 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
65 Years
ALL
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
Prof. Dr. Christian D. Etz, Head of Department, Department of Cardiac Surgery, Rostock University Medical Center
UNKNOWN
PD Dr. Johannes Ehler, Consultant, Department of Anesthesiology and Intensive Care Medicine, University Hospital Jena
UNKNOWN
University of Rostock
OTHER
Responsible Party
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Felix Klawitter, MD
Dr. med. Felix Klawitter, DESAIC
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
Countries
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Central Contacts
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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