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

NCT03456180 | Completed FDA Device

• 1 other identifier: cyto2018
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

septic shock; microcirculation; acute renal failure; renal replacement therapy; haemoadsorption

Outcome Measures

Primary Outcomes (1)

• improvement in perfused vessel density

  improvement in perfusion of the sublingual microcirculation

  24 hours

Secondary Outcomes (3)

• improvement in microvascular flow index

  6 hours and 24 hours

• improvement in tissue oxygenation

  6 hours and 24 hours

• improvement in perfused vessel density

  6 hours

Study Arms (1)

Haemoadsorption with Cytosorb cartridge

patients with septic shock and acute renal failure requiring renal replacement therapy with the haemoadsorption cartridge Cytosorb

Device: Haemoadsorption with Cytosorb cartridge

Interventions

Haemoadsorption with Cytosorb cartridge DEVICE

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

Haemoadsorption with Cytosorb cartridge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with septic shock requiring renal replacement therapy for acute renal failure and undergoing haemoadsorption with Cytosorb cartridge

You may qualify if:

• age\>18
• septic patients with acute kidney failure that need to undergo CHHV treatment.

You may not qualify if:

• hypersensitivity or allergy to the components of the cartridge
• pregnancy
• maxillary-facial trauma that prohibits mouth access and sublingual microcirculation evaluation.

Sponsors & Collaborators

• Università Politecnica delle Marche: lead

Related Publications (15)

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MeSH Terms

Conditions

Shock, Septic; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 7, 2018
• Study Start: December 9, 2016
• Primary Completion: December 15, 2017
• Study Completion: December 15, 2017
• Last Updated: March 8, 2018

Record last verified: 2018-03