Gal-3: Galectin and Respiratory Weaning

Sponsor
Asklepios Neurological Clinic Bad Salzhausen (Other)
Overall Status
Recruiting
CT.gov ID
NCT05054556
Collaborator
(none)
150
1
19.9
7.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Labaratory tests

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

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prognostic Value of Galectin-3 for Success of Respiratory Weaning
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Outcome Measures

Primary Outcome Measures

  1. To correlate the serum levels of galectin-3 and duration of respiratory weaning. [2-3 months]

    Labaratory test+Clinical data.

Secondary Outcome Measures

  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. [2-3 months]

    Clinical data, labaratory tests.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • written informed consent

  • mechanical ventilation

Exclusion Criteria:
  • history of pulmonary disease

  • left ventricular ejection fraction<45%

  • missing declaration of consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Neurologische Klinik Bad Salzhausen Nidda Germany 63667

Sponsors and Collaborators

  • Asklepios Neurological Clinic Bad Salzhausen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Asklepios Neurological Clinic Bad Salzhausen
ClinicalTrials.gov Identifier:
NCT05054556
Other Study ID Numbers:
  • Galectin14092021
First Posted:
Sep 23, 2021
Last Update Posted:
Feb 17, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 17, 2022