Use of Extracorporeal Treatment With the Cytosorb-Adsorber for the Reduction of SIRS in Heart Surgery Patients

NCT02265419 | Unknown DMC

• 1 other identifier: A 2014-0064
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Heart-surgery with the use of a heart-lung-machine can trigger the development of a full-blown SIRS (Systemic Inflammatory Response Syndrom) with multi organ failure and severe sepsis in the course of disease. For the treatment of full-blown SIRS extracorporeal treatment like the Cytosorb-Adsorber are in clinical testing. The Cytosorb-Adsorber is a CE-signed medical device with approval for the treatment of severe sepsis and hyperinflammation. The adsorber remove not-specific cytokines and other inflammation mediators from the patients blood. In this study (as a case-observation and compassionate use) the effect of extracorporeal treatment with the Cytosorb-Adsorber for the reduction of postoperative hyperinflammation and SIRS after heart-surgery with use of a heart-lung-machine will be observed. The aim of the study is recording the influence of the treatment with the Cytosorb-Adsorber on the course of hyperinflammation and multi organ failure in comparison with a historic control group.

Conditions

Multiple Organ Failure

Keywords

hyperinflammation, Cytosorb

Outcome Measures

Primary Outcomes (1)

• mean SOFA

  A significant difference in the mean-SOFA (Sequential Organ Failure Assessment)-score between the Cytosorb-group and the historic control group after 7 days.

  day 7

Secondary Outcomes (4)

• 30- and 90-day survival

  day 30, day 90

• time of respirator-therapy

  day 90

• length of ICU stay

  day 90

• dosage of vasopressors on the days 1, 2 and 3.

  day 1, 2 and 3

Study Arms (1)

Cytosorb group

EXPERIMENTAL

Extracorporeal treatment with the Cytosorb adsorber for 24 hours after heart surgical operation.

Device: Extracorporeal treatment with the Cytosorb adsorber

Interventions

Extracorporeal treatment with the Cytosorb adsorber DEVICE

The extracorporeal treatment with the Cytosorb-Adsorber will be started 6 hours after heart surgery operation, the extracorporeal treatment duration will be 24 hours and the observation time 90 days.

Cytosorb group

Eligibility Criteria

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

You may qualify if:

• After heart surgery with heart-lung-machine
• or more positive SIRS criterions within 6 hours postoperative
• need of \> 1,9 liter kristalloids within 6 hours postoperative
• centralvenous oxygen saturation \>75% within 6 hours postoperative
• need of vasopressors (≥0,06 µg/Kg/Min) within 6 hours postoperative

You may not qualify if:

• Bleeding
• Thrombocyten \< 20.000 /µl, INR\>3,0
• HIV-Test positive
• Hepatitis C positive

Sponsors & Collaborators

• University of Rostock: lead

Study Sites (1)

Intensive Care Units PIT 1+2, University hospital Rostock

Rostock, 18055, Germany

RECRUITING

MeSH Terms

Conditions

Multiple Organ Failure

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Sauer, PD Dr.

  University of Rostock, University Hospital, Intensive Care, Schillingallee 35, 18055 Rostock, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Sauer, PD Dr.

CONTACT

49 381 4946409; martin.sauer@uni-rostock.de

Johannes Ehler, Dr.

CONTACT

49 381 4946401; johannes.ehler@med.uni-rostock.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr.

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 15, 2014
• Study Start: October 1, 2014
• Primary Completion: January 1, 2022
• Study Completion: March 1, 2022
• Last Updated: April 7, 2020

Record last verified: 2020-04

Locations

DE (1)