Last reviewed · How we verify

NCT03456180

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

Completed Last updated 8 March 2018
What this trial tests

trial testing Haemoadsorption with Cytosorb cartridge in Septic Shock in 10 participants. Completed in 15 December 2017.

Timeline
9 December 2016
Primary endpoint
15 December 2017
15 December 2017

Quick facts

Lead sponsorUniversità Politecnica delle Marche
StatusCompleted
Study typeOBSERVATIONAL
Enrollment10
Start date9 December 2016
Primary completion15 December 2017
Estimated completion15 December 2017

Drugs / interventions tested

Conditions studied

Sponsor

Università Politecnica delle Marche — full company profile →

Who can join

18 and older, any sex, with Septic Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Septic Shock

Currently open trials in the same condition.

Other Università Politecnica delle Marche trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03456180.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing