Galectin and Respiratory Weaning (Gal-3)

September 25, 2023 updated by: Asklepios Neurological Clinic Bad Salzhausen

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Bad König, Germany, 64732
        • Recruiting
        • Asklepios Schlossberg Klinik Bad König
        • Contact:
          • Michael Hartwich, MD
          • Phone Number: +49 60 63 5010
      • Nidda, Germany, 63667
        • Recruiting
        • Neurologische Klinik Bad Salzhausen
        • Contact:
          • Jens Allendörfer, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with mechanical ventilation who are admitted to our hospital for respiratory weaning.

Description

Inclusion Criteria:

  • written informed consent
  • mechanical ventilation

Exclusion Criteria:

  • history of pulmonary disease
  • left ventricular ejection fraction<45%
  • missing declaration of consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To correlate the serum levels of galectin-3 and duration of respiratory weaning.
Time Frame: 2-3 months
Labaratory test+Clinical data.
2-3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Clinical data, labaratory tests.
2-3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asklepios Neurological Clinic Bad Salzhausen

Collaborators

Asklepios Schlossberg Clinic Bad Koenig

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

September 14, 2021

First Submitted That Met QC Criteria

September 14, 2021

First Posted (Actual)

September 23, 2021

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Galectin14092021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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