MedTrace Logo

Changes in Microvascular Perfusion During Blood Purification With Cytosorb® in Septic Shock

NCT03456180 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2018-03-08

No results posted yet for this study

Summary

Sepsis is defined as a life-threatening event due to a dysregulated immune response to an host. Blood purification techniques may be considered as a therapeutic weapon to front sepsis and septic shock.

Haemoadsorption is one of the known blood purification technique that is employed in this study, and it is based on the principle that whole blood, contacting the surface of proper designed sorbent, would be cleared of certain substrates. With haemoadsorption it is possible to de-circulate from bloodstream high molecular weight substances, such as cytokines.In this study Cytosorb® cartridge, based on haemoadsorption principle is applied on septic patients, suffering for acute kidney failure, along with continuous veno-venous haemodialysis (CVVH-D).Microcirculation has a crucial role in the natural history of sepsis.

In this prospective observational non interventional study, 10 septic patients with an acute kidney failure that need CVVH are enrolled.

The primary endpoint of the study is to verify an improvement in the density of microcirculatory vessels and in the quality of blood flow after exposure to Cytosorb®. These two parameters are well described synthetically by the Perfused Vessel Density (PVD).

As secondary endpoints we also want to analyze the modification of microcirculation after haemoadsorption therapy: microvascular blood flow, described by the microvascular flow index (MFI) and peripheral tissue oxygen perfusion during Cytosorb® exposure using near infrared spectroscopy technique (NIRS)

Conditions

  • Septic Shock

Interventions

DEVICE

Haemoadsorption with Cytosorb cartridge

microcirculatory monitoring in septic shock patients requiring renal replacement therapy for acute renal failure and haemoadsorption with Cytosorb cartridge

Sponsors & Collaborators

  • Università Politecnica delle Marche

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-09
Primary Completion
2017-12-15
Completion
2017-12-15
FDA Device
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03456180 on ClinicalTrials.gov