Heparin-binding Protein and Lungedema in ICU Patients.

NCT07434908 | Recruiting

• 1 other identifier: 2023-04507-01
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this single center observational cohort study is to investigate the relationship between physiological measures of lung oedema, and the biomarker Heparin-binding Protein (HBP). The main questions it aims to answer are:

• Does the concentration of HBP in plasma correlate with measures of lung vascular permeability and extravascular water in the lungs?
• Does the concentration of HBP in plasma correlate with the patient's total accumulated fluid balance? Researchers will collect blood samples and gather information on lung vascular permeability and extravascular lung water in Intensive care patients who are provided with a hemodynamic surveillance system called PiCCO. The study will include 25 patients.

Conditions

Lung Edema

Keywords

Heparin-binding Protein; Lung Edema; Vascular permeability; Vascular leak; respiratory failure; PiCCO; Transpulmonary Thermodilution Technique

Outcome Measures

Primary Outcomes (1)

• Correlation of Heparin-Binding Protein (HBP) and pulmonary vascular permeability Index (PVPI)

  The primary outcome is the correlation between concentration of HBP in plasma and PVPI. These values will be visualised using scatterplots with corresponding correlation coefficients. The statistical work up will include a Mann Whitney U test comparing the mean PVPI in the group of patients with HBP above median and the group of patients with HBP below median. Further statistics will include regression analysis depending on the nature of the results.

  Patients are included in the study for as long as the PICCO monitoring is connected but with a maximum of three days.

Secondary Outcomes (1)

• The correlation between mean HBP for each patient and total fluid balance.

  From enrollment through study completion, a maximum of five days.

Study Arms (1)

Intensive Care patients monitored with a PiCCO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All ICU adult patients admitted to the ICU in Östersund fulfilling the inclusion criterias above.

You may qualify if:

• Patients \>18 years
• Monitored with a PiCCO system

You may not qualify if:

• Patients transferred from another ICU

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

ICU

Östersund, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bloodsamples are spinned to plasma and frozen until analysis of HBP

MeSH Terms

Conditions

Pulmonary Edema; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Line Samuelsson, MD

CONTACT

063153000; line.samuelsson@regionjh.se

Study Design

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

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 27, 2026
• Study Start: May 6, 2024
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)