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NCT03456180
Changes in Microvascular Perfusion During Blood Purification With Cytosorb® in Septic Shock
trial testing Haemoadsorption with Cytosorb cartridge in Septic Shock in 10 participants. Completed in 15 December 2017.
15 December 2017
Quick facts
| Lead sponsor | Università Politecnica delle Marche |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 10 |
| Start date | 9 December 2016 |
| Primary completion | 15 December 2017 |
| Estimated completion | 15 December 2017 |
Drugs / interventions tested
- Haemoadsorption with Cytosorb cartridge
Conditions studied
- Septic Shock — all drugs for Septic Shock →
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:
- PubMed search for NCT03456180
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other recruiting trials for Septic Shock
Currently open trials in the same condition.
- NCT07179276 — Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock · NA · recruiting
- NCT07383103 — Hydrocortisone and Fludrocortisone for the Treatment of Septic Shock · Phase 4 · recruiting
- NCT07419802 — OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study · recruiting
- NCT07264543 — Early Methylene Blue in the Microhemodynamics of Septic Patients · Phase 2, PHASE3 · recruiting
- NCT04855786 — External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients · NA · recruiting
Other Università Politecnica delle Marche trials
Trials by the same sponsor.
- NCT07189520 — 1. SAFE-AI ONCO-TRACK: Multimodal GenAI for Early Detection of Minimal Residual Disease and Recurrence in Gastrointestin · not yet recruiting
- NCT07404475 — Microcirculation and Coagulopathy in Sepsis · completed
- NCT06272448 — teleRehabilitation for pAtients With ParkInson's Disease at Any mOment · NA · completed
- NCT05267834 — Adenocarcinoma of the Uterine Cervix and HPV · completed
- NCT05110950 — Endobronchial Ultrasound Needle Aspiration With and Without Suction · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03456180 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Università Politecnica delle Marche
- Last refreshed: 8 March 2018
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.
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