NCT05054556

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 23, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

September 26, 2023

Status Verified

June 1, 2023

Enrollment Period

3.2 years

First QC Date

September 14, 2021

Last Update Submit

September 25, 2023

Conditions

Galectin-3 During Respiratory Weaning

Outcome Measures

Primary Outcomes (1)

  • To correlate the serum levels of galectin-3 and duration of respiratory weaning.

    Labaratory test+Clinical data.

    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.

    2-3 months

Interventions

Labaratory testsDIAGNOSTIC_TEST

Estimation of serum levels of the following parameters: galectin-3, proBNP, TNI, proGRP, CA15-3, CK, creatinine, urea, crp, pct, leucozytes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • written informed consent
  • mechanical ventilation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Asklepios Schlossberg Klinik Bad König

Bad König, 64732, Germany

RECRUITING

Neurologische Klinik Bad Salzhausen

Nidda, 63667, Germany

RECRUITING

Central Study Contacts

Dirk Bandorski, MD

CONTACT

+496043804212d.bandorski@asklepios.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2021

First Posted

September 23, 2021

Study Start

November 1, 2021

Primary Completion

December 31, 2024

Study Completion

June 30, 2025

Last Updated

September 26, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)