CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Haemoadsorption with Cytosorb cartridgedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03456180
NCT03456180N/ACompleted

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

Università Politecnica delle Marche·observational·Posted Mar 7, 2018·Updated Mar 8, 2018

In Brief

An observational study evaluating Haemoadsorption with Cytosorb cartridge for Septic Shock. Completed, enrolled 10 participants.

Detailed 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)

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSeptic Shock
Countries--
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 7, 2018
Enrollment StartDec 9, 2016
Primary CompletionDec 15, 2017
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 8.3 years ago

Interventions

Haemoadsorption with Cytosorb cartridgedevice

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