FrailtyPREDICTNCT06175429
Prognostic Value of Exhaled Isoprene Levels for Morbidity and Functional Outcome in Cardiosurgical Patients
An observational study of Frailty and Muscle Weakness, run by University of Rostock at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Muscle Weakness, Volatile Organic Compounds
- What is being tested?
- Physical performance testing, Breath sampling and VOC analysis and Muscle ultrasound
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- 27 Nov 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients undergoing elective cardiac surgery
Who may be able to join
- Age >= 65 years
- planned cardiac surgery
- operation duration >60 min
Who cannot join
- 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
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- current malignant disease
- terminal renal insufficiency
- severe liver cirrhosis
- severe obstructive pulmonary disease
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, Rostock University Medical Center
Rostock, Mecklenburg-Vorpommern, 18057
Felix Klawitter, Dr. med., +493814946382, felix.klawitter@med.uni-rostock.de
About this study
Official title: Prognostic Value of Exhaled Isoprene Levels for Morbidity and Functional Outcome in Cardiosurgical Patients - A Single Center Prospective Observational Cohort Study
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.
Read the detailed 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
- Conditions
- Frailty, Muscle Weakness, Volatile Organic Compounds, Isoprene
- Being tested
- Physical performance testing, Breath sampling and VOC analysis, Muscle ultrasound, Blood-based biomarker analysis
- Medical subject headings
- Frailty, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical performance testingDiagnostic test
Assessment of physical performance using established clinical tests and scoring systems
Breath sampling and VOC analysisDiagnostic test
Sampling of exhaled breath and using Proton-transfer-reaction time-of-flight mass spectrometry (PTR-TOF) for VOC quantification.
Muscle ultrasoundDiagnostic test
Quantitative and qualitative assessment of different limb skeletal muscles using non-invasive ultrasound.
Blood-based biomarker analysisDiagnostic test
Blood sampling and assessment of different blood-based biomarkers of muscle integrity using Enzyme-linked Immunosorbent Assay (ELISA) and Electrochemiluminescence Immunoassay (ECLIA)
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgery | Patients undergoing elective cardiac surgery Receives: Diagnostic Test: Physical performance testing; Diagnostic Test: Breath sampling and VOC analysis; Diagnostic Test: Muscle ultrasound; Diagnostic Test: Blood-based biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 5 after surgery
Secondary outcomes (6)
Cumulated Ambulation Score
Assessment of functional patient outcome using the Cumulated Ambulation Score (CAS, Score, scales 0-6), whereby a higher CAS corresponds to a better functional outcome.
Measured: days 5 and 30 after surgery
Morbidity
Assessment of the cumulative number of postoperative complications after surgery.
Measured: day 30 after surgery
Isoprene concentration in patients with and without frailty
Comparison of exhaled isoprene levels (concentrations, part per billion volume - ppbV) measured by PTR-TOF between patients with and without physical frailty.
Measured: day 5 after surgery
Medical Research Council Sum Score
Assessment of general muscle strength of study participants using the Medical Research Council Sum Score (MRCSS, Score, scales 0-60), whereby a higher MRCSS corresponds to a higher muscle strength.
Measured: day 5 after surgery
Muscle thickness
Assessment of muscle thickness (mm) using muscle ultrasound in eight different limb skeletal muscles.
Measured: day 5 after surgery
Concentrations of blood-based biomarkers
Assessment of blood-based biomarker concentrations (pmol/l) of skeletal muscle integrity and metabolism.
Measured: day 5 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start27 Nov 2023
- Primary completion1 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Rostock, Jena University Hospital
- Responsible party
- Principal investigator, Felix Klawitter, MD, University of Rostock
- Investigators
- Felix Klawitter, Dr. med., Principal investigator, Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, Rostock University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175429
- Sponsor's protocol ID
- PREDICT
- Acronym
- PREDICT
- Status last verified
- Dec 2023
- First submitted
- 29 Nov 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Exhaled Isoprene Levels for Morbidity and Functional Outcome in Cardiosurgical Patients - A Single Center Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06175429
- Acronym / sponsor ID
- PREDICT / PREDICT
- Conditions
- Frailty, Muscle Weakness, Volatile Organic Compounds, Isoprene
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Collaborators
- University Medical Center Rostock, Jena University Hospital
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery | – | Diagnostic Test: Physical performance testing, Diagnostic Test: Breath sampling and VOC analysis, Diagnostic Test: Muscle ultrasound, Diagnostic Test: Blood-based biomarker analysisPatients undergoing elective cardiac surgery |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients undergoing elective cardiac surgery
Key inclusion criteria (3 listed)
- Age >= 65 years
- planned cardiac surgery
- operation duration >60 min
Key exclusion criteria (10 listed)
- refusal of study participation
- emergency / urgent surgery
- acute myocardial infarction
- acute or chronic infection
- Pre-existing illness with permanent restriction of mobility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical performance testingAssessment of physical performance using established clinical tests and scoring systems | Diagnostic test | Cardiac surgery |
| Breath sampling and VOC analysisSampling of exhaled breath and using Proton-transfer-reaction time-of-flight mass spectrometry (PTR-TOF) for VOC quantification. | Diagnostic test | Cardiac surgery |
| Muscle ultrasoundQuantitative and qualitative assessment of different limb skeletal muscles using non-invasive ultrasound. | Diagnostic test | Cardiac surgery |
| Blood-based biomarker analysisBlood sampling and assessment of different blood-based biomarkers of muscle integrity using Enzyme-linked Immunosorbent Assay (ELISA) and Electrochemiluminescence Immunoassay (ECLIA) | Diagnostic test | Cardiac surgery |
Primary outcome
Short Physical Performance Battery
Time frame: day 5 after surgery
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.
6 secondary outcomes
Cumulated Ambulation Score
Time frame: days 5 and 30 after surgery
Morbidity
Time frame: day 30 after surgery
Isoprene concentration in patients with and without frailty
Time frame: day 5 after surgery
Medical Research Council Sum Score
Time frame: day 5 after surgery
Muscle thickness
Time frame: day 5 after surgery
Concentrations of blood-based biomarkers
Time frame: day 5 after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix Klawitter, Dr. med. principal investigator
Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, Rostock University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Muscle Weakness, run by University of Rostock at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Felix Klawitter, Dr. med. (+49381494146382, felix.klawitter@med.uni-rostock.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (time frame: day 5 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.