Heparin-binding Protein and Lungedema in ICU Patients.
ConditionLung Edema
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUmeå University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients >18 years
Monitored with a PiCCO system
Disqualifiers
None
Trial population
All ICU adult patients admitted to the ICU in Östersund fulfilling the inclusion criterias above.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
25 Participants
are grouped into 1 trial groupGroup A: Intensive Care patients monitored with a PiCCO
Trial outcomes
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.
Time frame
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.
The total fluid balance is the accumulated daily balances from arrival in the ICU until end of the study expressed as a mean of millilitre per kilo per hour (ml/kg/h) The results will be plotted in a scatter plot, a correlation coefficient calculated, and a linear regression analysed with HBP as the independent variable and fluid balance (ml/kg/h). A statistical analysis of the mean fluid balance in the group of patients with a HBP above the median will be compared with the mean fluid balance in the group of patients with a mean HBP below the median using Mann Whitney U test.
Time frame
From enrollment through study completion, a maximum of five days.Sponsors and contacts
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Source ClinicalTrials.gov