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Completed

NCT Number: NCT04309591

Cytosorb Therapy in Cardiac Surgery

Cardiopulmonary surgery is associated with inflammatory responses that can lead to systemic inflammatory responses (SIRS), organ dysfunction (MOD) and death especially in patients with endocarditis. Cytokine removal might therefore improve outcomes of patients undergoing cardiac surgery. CytoSorb is a device designed to remove cytokine (IL-6, IL-10, TNFalpha) from the blood to reduce immune reactions. This trial investigates the use of CytoSorb during cardiac surgery in patients with endocarditis at the University Hospital Basel.

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Key information

Conditions

Cardiopulmonary Surgery Cardiovascular Diseases Endocarditis Heart Diseases Peri-operative Cytokines Levels

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinik für Herzchirurgie, Universitätsspital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with endocarditis undergoing cardiac surgery with cardio-pulmonary bypass circuit

Exclusion criteria

  • denial of consent for data use

Treatment and study plan

CytoSorb haemoadsorption (HA) device

Device

CytoSorb® cartridges contain biocompatible sorbent polystyrene divinylbenzene beads coated with polyvinylpyrrolidone, capable of removing inflammatory molecules (eg Interleukin). The cartridge is inserted in a cardio-pulmonary bypass circuit to remove inflammatory molecules during cardiac surgery .

Primary outcomes

  1. In-Hospital mortality

    Time frame: during hospital stay for cardiac surgery from admission until discharge (approximately 15 days)

    In-Hospital mortality (number of deaths) of patients with endocarditis undergoing cardiac surgery and intra-operative CytoSorb haemoadsorption

Secondary outcomes

  1. time in intensive care unit (days)

    Time frame: during hospital stay for cardiac surgery from admission until discharge (approximately 15 days)

    time in intensive care unit (days)

  2. In-Hospital time (days)

    Time frame: hospital stay for cardiac surgery from admission until discharge (approximately 15 days)

    In-Hospital time (days)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Cytosorb Therapy in Cardiac Surgery - a Retrospective Study of Hemoadsorption in Patients With Endocarditis

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 16, 2020
Registry last updated
Mar 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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