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

NCT ID: NCT02265419

Last Updated: 2020-04-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2022-03-31

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.

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.

Conditions

Multiple Organ Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cytosorb group

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

Group Type: EXPERIMENTAL

Extracorporeal treatment with the Cytosorb adsorber

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rostock

OTHER

Sponsor Role: lead

Responsible Party

Dr. Martin Sauer, MD

PD Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Sauer, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Intensive Care Units PIT 1+2, University hospital Rostock

Rostock, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Martin Sauer, PD Dr.

Role: CONTACT

martin.sauer@uni-rostock.de

49 381 4946409

Johannes Ehler, Dr.

Role: CONTACT

johannes.ehler@med.uni-rostock.de

49 381 4946401

Facility Contacts

Martin Sauer, PD Dr.

Role: primary

49 381 4946434

Other Identifiers

A 2014-0064

Identifier Type: -

Identifier Source: org_study_id