Image

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

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

Recruiting
65 years and older
All
Phase N/A

Powered by AI

Overview

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

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

Study details
    Frailty
    Muscle Weakness
    Volatile Organic Compounds
    Isoprene

NCT06175429

University of Rostock

26 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.