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A Study of Exosome Proteomics and Hemodynamics in Sepsis

B

Buddhist Tzu Chi Medical Foundation

Status

Completed

Conditions

Autophagy
Hemodynamic Instability

Treatments

Diagnostic Test: Hemodynamic parameters

Study type

Observational

Funder types

Other

Identifiers

NCT03267160
05-XD15-039

Details and patient eligibility

About

This research will be the first study for exosomes purified in blood and urine from septic patients who had multiple organ failures. Proteomics studies in exosomes from blood or urine specimens. Analyze autophage, and apoptosis related biomarkers of exosomes by bioinformatics. To find the correlations between exosomes biomarkers and hemodynamic parameters.

Full description

Background: Sepsis, defined as an infection with evidence of systemic infection, continues to be a source of considerable morbidity and mortality. Many animal sepsis models had found that sepsis induced multiple organ failure. Autophagy, apoptosis may involve the process of sepsis related multiple organ failure. Mass spectrometry-based proteomics studies in clinical populations and in rodent and mammalian animal models had started with discovered many novel biomarkers of sepsis. Esoxomes had been found in blood or urine presented the signal of autophagy and apoptosis. On the other hand, pulse contour cardiac output (PiCCO) can calculate hemodynamic parameters that had been used for evaluation in cardiopulmonary failure of sepsis.

Aims of the study: This research will be the first study for exosomes purified in blood and urine from septic patients who had multiple organ failures. Proteomics studies in exosomes from blood or urine specimens. Analyze autophage, and apoptosis related biomarkers of exosomes by bioinformatics. To find the correlations between exosomes biomarkers and hemodynamic parameters.

Materials and Methods: A total of 30 patients with sepsis, septic shock, or multiple organ failure will be included, of whom 15 septic patients had cardiopulmonary organ failure, others will be not. All patients included and classified according to the surviving sepsis campaign criteria, also treat according to surviving sepsis campaign guidelines. Data will be collected from January 2016 to December 2016. Exosome will be isolated and purified by sucrose gradient ultracentrifugation. Magnetic beads purification, 2D gel electrphoresis, and MALDI-TOF will be used to analyze proteomics of exosome in urine or blood of septic patients. Western blotting will be done to prove the proteins found by proteomics. Pulse contour cardiac output monitored heart contractility, end-diastolic volume parameters, and lung water parameters. Finally, to find the correlations between exosome specific organ and autophagy-apoptosis biomarkers and hemodynamic parameters.

Possible effect: Systematic establishment of exosome proteomics in blood and urine from septic patients who had multiple organ failure or not will be done. Autophagy-apoptosis biomarkers in exosomes will be detected and correlated to hemodynamic parameters, to judge specific organ failure in sepsis.

Enrollment

30 patients

Sex

All

Ages

20 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patients with sepsis who admit to ICU
  2. Sepsis diagnostic criteria: acute change in total SOFA score ≥ 2 points attributable to infection
  3. Pulse indicator continuous cardiac output monitor (PiCCO) is accept by patient for hemodynamic monitoring

Exclusion criteria

  1. Patients with acute SOFA changes < 2 points are excluded
  2. auria, no urine can be collected
  3. Previous cardiopulmonary co-morbidity. Chronic respiratory failure with ventilator dependence and chronic heart failure.

Trial design

30 participants in 2 patient groups

Sepsis with cardiopulmonary failure
Description:
Patient with sepsis and also respiratory and heart involvement, confirmed by Hemodynamic parameters
Treatment:
Diagnostic Test: Hemodynamic parameters
Sepsis without cardiopulmonary failure
Description:
Patient with sepsis without respiratory and heart involvement
Treatment:
Diagnostic Test: Hemodynamic parameters

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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