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

NCT06175429 | Unknown

• 1 other identifier: PREDICT
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Muscle Weakness; Volatile Organic Compounds; Isoprene

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Cumulated Ambulation Score

  days 5 and 30 after surgery

• Morbidity

  day 30 after surgery

• Isoprene concentration in patients with and without frailty

  day 5 after surgery

• Medical Research Council Sum Score

  day 5 after surgery

• Muscle thickness

  day 5 after surgery

Study Arms (1)

Cardiac surgery

Patients undergoing elective cardiac surgery

Diagnostic Test: Physical performance testing; Diagnostic Test: Breath sampling and VOC analysis; Diagnostic Test: Muscle ultrasound; Diagnostic Test: Blood-based biomarker analysis

Interventions

Physical performance testing DIAGNOSTIC_TEST

Assessment of physical performance using established clinical tests and scoring systems

Cardiac surgery

Breath sampling and VOC analysis DIAGNOSTIC_TEST

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

Cardiac surgery

Muscle ultrasound DIAGNOSTIC_TEST

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

Cardiac surgery

Blood-based biomarker analysis DIAGNOSTIC_TEST

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

Cardiac surgery

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective cardiac surgery

You may qualify if:

• Age \>= 65 years
• planned cardiac surgery
• operation duration \>60 min

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Rostock, Mecklenburg-Vorpommern, 18057, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Frailty; Muscle Weakness

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Felix Klawitter, Dr. med.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felix Klawitter, Dr. med.

CONTACT

+49381494146382; felix.klawitter@med.uni-rostock.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Felix Klawitter, DESAIC

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 18, 2023
• Study Start: November 27, 2023
• Primary Completion: October 1, 2025
• Study Completion: December 31, 2025
• Last Updated: December 18, 2023

Record last verified: 2023-12

Locations

DE (1)