Galectin-3 During Respiratory WeaningGal-3NCT05054556
Galectin and Respiratory Weaning
An observational study of Galectin-3 During Respiratory Weaning, run by Asklepios Neurological Clinic Bad Salzhausen at 2 sites in Germany.
Trial summary
Galectin-3 is a biomarker for fibrotic activity. In the course of invasive ventilation, fibrotic changes in the lungs may occur. The study aims to investigate whether the level of galectin-3 levels correlates with clinical weaning parameters. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Galectin-3 During Respiratory Weaning
- What is being tested?
- Labaratory tests
- How many people
- 150 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Nov 2021to 30 Jun 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with mechanical ventilation who are admitted to our hospital for respiratory weaning.
Who may be able to join
- written informed consent
- mechanical ventilation
Who cannot join
- history of pulmonary disease
- left ventricular ejection fraction<45%
- missing declaration of consent
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Asklepios Schlossberg Klinik Bad König
Bad König, 64732
Michael Hartwich, MD, +49 60 63 5010
- Recruiting
Neurologische Klinik Bad Salzhausen
Nidda, 63667
Dirk Bandorski, MD, PhD, +496043804212, d.bandorski@asklepios.com
Jens Allendörfer, MD
About this study
Official title: Prognostic Value of Galectin-3 for Success of Respiratory Weaning
Galectin-3 is a biomarker for fibrotic activity. In the course of invasive ventilation, fibrotic changes in the lungs may occur. The study aims to investigate whether the level of galectin-3 levels correlates with clinical weaning parameters.
Read the detailed description
Galectin-3 (Gal-3) is a protein with an important role in cell-cell adhesion, cell-matrix interactions, macrophage activation, angiogenesis, metastasis and apoptosis. Galectin-3 is expressed in the nucleus, cytoplasm, mitochondrion, cell surface, and extracellular space.It is involved in different biological processes: cell adhesion, cell activation and chemoattraction, cell growth and differentiation, cell cycle, and apoptosis. Several studies revealed the function of galectin-3 in cancer, inflammation and (lung) fibrosis, heart disease, and stroke. Expression of galectin-3 is associated with heart failure, including myofibroblast proliferation, fibrogenesis, tissue repair, inflammation, and ventricular remodeling. A correlation between galectin-3 expression levels and various types of fibrosis has been found. Galectin-3 is upregulated in idiopathic pulmonary fibrosis.
Mechanical ventilation can cause lung damage, or worsen it if already present. This phenomenon is called ventilation-induced lung damage. Main mechanisms are high tidal volumes causing overexpansion of the lungs (volutrauma), high airway pressure (barotrauma) and cyclical collapse and reopening of atelectatic alveolar regions (atelectrauma) leading to a pulmonary inflammatory reaction called "bio-trauma".
To evaluate the (potential) lung injury serum levels of galectin-3 are measured on admission to our hospital. During respiratory weaning invasiveness of ventilation will be reduced. Data relating biomarkers especially galectin3 during/after successful respiratory weaning are missing.
This is why follow up measurements of galectin-3 will be done and correlated with ventilation parameters/duration/ success of respiratory weaning.
Prior studies evaluated the role of proGRP and CA 15-3 in patients with lung fibrosis. As a part of the study galectin-3 serum levels will be correlated with serum levels of proGRP and CA 15-3.
In summary the aim of this study is to evaluate the diagnostic value of galectin-3 in respiratory weaning.
- Conditions
- Galectin-3 During Respiratory Weaning
- Being tested
- Labaratory tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labaratory testsDiagnostic test
Estimation of serum levels of the following parameters:
galectin-3, proBNP, TNI, proGRP, CA15-3, CK, creatinine, urea, crp, pct, leucozytes
What is being measured
The primary outcome is the main question the study is designed to answer.
To correlate the serum levels of galectin-3 and duration of respiratory weaning.
Labaratory test+Clinical data.
Measured: 2-3 months
Secondary outcomes (1)
Serum levels of galectin-3 on admission, after weaning and discharge from hospital. Correlation of: galectin-3 and duration of respiratory weaning invasiveness of ventilation parameters and galectin-3 serum levels of galectin-3, proGRP and CA 15-3.
Clinical data, labaratory tests.
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start1 Nov 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Galectin-3 During Respiratory WeaningStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asklepios Neurological Clinic Bad Salzhausen
- Sponsor type
- University, hospital or other
- Collaborators
- Asklepios Schlossberg Clinic Bad Koenig
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054556
- Sponsor's protocol ID
- Galectin14092021
- Acronym
- Gal-3
- Status last verified
- Jun 2023
- First submitted
- 14 Sep 2021
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Galectin-3 for Success of Respiratory Weaning
- ClinicalTrials.gov ID
- NCT05054556
- Acronym / sponsor ID
- Gal-3 / Galectin14092021
- Conditions
- Galectin-3 During Respiratory Weaning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Asklepios Neurological Clinic Bad SalzhausenUniversity, hospital or other
- Collaborators
- Asklepios Schlossberg Clinic Bad Koenig
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 23 Sep 2021 (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.
Galectin-3 is a biomarker for fibrotic activity. In the course of invasive ventilation, fibrotic changes in the lungs may occur. The study aims to investigate whether the level of galectin-3 levels correlates with clinical weaning parameters.
Detailed description
Galectin-3 (Gal-3) is a protein with an important role in cell-cell adhesion, cell-matrix interactions, macrophage activation, angiogenesis, metastasis and apoptosis. Galectin-3 is expressed in the nucleus, cytoplasm, mitochondrion, cell surface, and extracellular space.It is involved in different biological processes: cell adhesion, cell activation and chemoattraction, cell growth and differentiation, cell cycle, and apoptosis. Several studies revealed the function of galectin-3 in cancer, inflammation and (lung) fibrosis, heart disease, and stroke. Expression of galectin-3 is associated with heart failure, including myofibroblast proliferation, fibrogenesis, tissue repair, inflammation, and ventricular remodeling. A correlation between galectin-3 expression levels and various types of fibrosis has been found. Galectin-3 is upregulated in idiopathic pulmonary fibrosis.
Mechanical ventilation can cause lung damage, or worsen it if already present. This phenomenon is called ventilation-induced lung damage. Main mechanisms are high tidal volumes causing overexpansion of the lungs (volutrauma), high airway pressure (barotrauma) and cyclical collapse and reopening of atelectatic alveolar regions (atelectrauma) leading to a pulmonary inflammatory reaction called "bio-trauma".
To evaluate the (potential) lung injury serum levels of galectin-3 are measured on admission to our hospital. During respiratory weaning invasiveness of ventilation will be reduced. Data relating biomarkers especially galectin3 during/after successful respiratory weaning are missing.
This is why follow up measurements of galectin-3 will be done and correlated with ventilation parameters/duration/ success of respiratory weaning.
Prior studies evaluated the role of proGRP and CA 15-3 in patients with lung fibrosis. As a part of the study galectin-3 serum levels will be correlated with serum levels of proGRP and CA 15-3.
In summary the aim of this study is to evaluate the diagnostic value of galectin-3 in respiratory weaning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mechanical ventilation who are admitted to our hospital for respiratory weaning.
Key inclusion criteria (2 listed)
- written informed consent
- mechanical ventilation
Key exclusion criteria (3 listed)
- history of pulmonary disease
- left ventricular ejection fraction<45%
- missing declaration of consent
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 |
|---|---|---|
| Labaratory testsEstimation of serum levels of the following parameters: galectin-3, proBNP, TNI, proGRP, CA15-3, CK, creatinine, urea, crp, pct, leucozytes | Diagnostic test | – |
Primary outcome
To correlate the serum levels of galectin-3 and duration of respiratory weaning.
Time frame: 2-3 months
Labaratory test+Clinical data.
1 secondary outcome
Serum levels of galectin-3 on admission, after weaning and discharge from hospital. Correlation of: galectin-3 and duration of respiratory weaning invasiveness of ventilation parameters and galectin-3 serum levels of galectin-3, proGRP and CA 15-3.
Time frame: 2-3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Galectin-3 During Respiratory Weaning, run by Asklepios Neurological Clinic Bad Salzhausen at 2 sites 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 2 inclusion and 3 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 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Dirk Bandorski, MD (+496043804212, d.bandorski@asklepios.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To correlate the serum levels of galectin-3 and duration of respiratory weaning. (time frame: 2-3 months). 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 26 Sep 2023.