Multiple Organ Failure Clinical Trial
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
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.
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.
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