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

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ClinicalTrials.gov Identifier: NCT02265419
Recruitment Status : Recruiting
First Posted : October 15, 2014
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Martin Sauer, MD, University of Rostock

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.


Condition or disease Intervention/treatment Phase
Multiple Organ Failure Device: Extracorporeal treatment with the Cytosorb adsorber Not Applicable

Detailed Description:

All patients underlying heart surgery with the use of a heart-lung-machine and fullfilling of the inclusion-criteria should be sreened for the study. The study take place on two surgical intensive care units (PIT I and PIT II) of the university hospital Rostock, Germany. The extracorporeal treatment with the Cytosorb-Adsorber will be started 6 hours after end of the operation if written informed consent was obtained from all participants or from the patients` representatives if direct consent could not be received. The extracorporeal treatment duration will be 24 hours and the observation time 90 days.

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. The main-criterion is a significant difference in the mean-SOFA (Sequential Organ Failure Assessment)-score between the Cytosorb-group and the historic control group after 7 days. Beside criterions are the 30- and 90-day survival, time of respirator-therapy, length of ICU stay, severity of the Critical Illness Polyneuropathy and dosage of vasopressors on the days 1, 2 and 3.

From all patients basic demographic information, illness severity (APACHE II, SOFA scores), microbiological results, pre-morbidity, and clinical outcome for study cohort will recorded. At the days 1-4, 7, 14, 30 and before/after the extracorporeal treatment the patients will screened for clinical and immunological data: hemodynamic, inflammation, coagulation, hemolysis, temperature, organ function blood parameters and cytokines. "Day 1" was defined as the day of the beginning of the extracorporeal treatment. At days 1, 2 and 7 hemodynamic monitoring will done with the PiCCO-System (PULSION Medical Systems, Feldkirchen, Germany). For dynamic measurement of the liver function will used the LiMON-System (based on the indocyanin green plasma disappearance rate, PULSION) on the days 1, 2 and 7.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Case-observation and Compassionate Use: Use of Extracorporeal Treatment With the Cytosorb-Adsorber for the Reduction of Postoperative Hyperinflammation and SIRS After Heart-surgery With the Use of a Heart-lung-machine
Study Start Date : October 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cytosorb group
Extracorporeal treatment with the Cytosorb adsorber for 24 hours after heart surgical operation.
Device: Extracorporeal treatment with the Cytosorb adsorber
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.



Primary Outcome Measures :
  1. mean SOFA [ Time Frame: day 7 ]
    A significant difference in the mean-SOFA (Sequential Organ Failure Assessment)-score between the Cytosorb-group and the historic control group after 7 days.


Secondary Outcome Measures :
  1. 30- and 90-day survival [ Time Frame: day 30, day 90 ]
    Observation time 90 days.

  2. time of respirator-therapy [ Time Frame: day 90 ]
    Observation time 90 days.

  3. length of ICU stay [ Time Frame: day 90 ]
    Observation time 90 days.

  4. dosage of vasopressors on the days 1, 2 and 3. [ Time Frame: day 1, 2 and 3 ]
    Use of Vasopressors are monitored.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • After heart surgery with heart-lung-machine
  • 2 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02265419


Contacts
Contact: Martin Sauer, PD Dr. 49 381 4946409 martin.sauer@uni-rostock.de
Contact: Johannes Ehler, Dr. 49 381 4946401 johannes.ehler@med.uni-rostock.de

Locations
Germany
Intensive Care Units PIT 1+2, University hospital Rostock Recruiting
Rostock, Germany, 18055
Contact: Martin Sauer, PD Dr.    49 381 4946434      
Sponsors and Collaborators
University of Rostock
Investigators
Principal Investigator: Martin Sauer, PD Dr. University of Rostock, University Hospital, Intensive Care, Schillingallee 35, 18055 Rostock, Germany

Responsible Party: Dr. Martin Sauer, MD, PD Dr., University of Rostock
ClinicalTrials.gov Identifier: NCT02265419     History of Changes
Other Study ID Numbers: A 2014-0064
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017

Keywords provided by Dr. Martin Sauer, MD, University of Rostock:
hyperinflammation, Cytosorb

Additional relevant MeSH terms:
Multiple Organ Failure
Shock
Pathologic Processes