Multiple Organ FailureCASHSPNCT02265419
Use of Extracorporeal Treatment With the Cytosorb-Adsorber for the Reduction of SIRS in Heart Surgery Patients
A study testing Extracorporeal treatment with the Cytosorb adsorber in people with Multiple Organ Failure, run by University of Rostock at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Organ Failure
- What is being tested?
- Extracorporeal treatment with the Cytosorb adsorber
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Bleeding
- Thrombocyten < 20.000 /µl, INR>3,0
- HIV-Test positive
- Hepatitis C positive
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Intensive Care Units PIT 1+2, University hospital Rostock
Rostock, 18055
Martin Sauer, PD Dr., 49 381 4946434
About this study
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.
Read more
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.
Read the 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
- Being tested
- Extracorporeal treatment with the Cytosorb adsorber
- Keywords
- hyperinflammation, Cytosorb
- Medical subject headings
- Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal treatment with the Cytosorb adsorberDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Cytosorb group | Experimental | Extracorporeal treatment with the Cytosorb adsorber for 24 hours after heart surgical operation. Receives: Device: Extracorporeal treatment with the Cytosorb adsorber |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 7
Secondary outcomes (4)
30- and 90-day survival
Observation time 90 days.
Measured: day 30, day 90
time of respirator-therapy
Observation time 90 days.
Measured: day 90
length of ICU stay
Observation time 90 days.
Measured: day 90
dosage of vasopressors on the days 1, 2 and 3.
Use of Vasopressors are monitored.
Measured: day 1, 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Organ FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Martin Sauer, MD, University of Rostock
- Investigators
- Martin Sauer, PD Dr., Principal investigator, University of Rostock, University Hospital, Intensive Care, Schillingallee 35, 18055 Rostock, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265419
- Sponsor's protocol ID
- A 2014-0064
- Acronym
- CASHSP
- Status last verified
- Apr 2020
- First submitted
- 9 Oct 2014
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02265419
- Acronym / sponsor ID
- CASHSP / A 2014-0064
- Conditions
- Multiple Organ Failure
- Keywords
- hyperinflammation, Cytosorb
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 15 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cytosorb group | Experimental | Device: Extracorporeal treatment with the Cytosorb adsorberExtracorporeal treatment with the Cytosorb adsorber for 24 hours after heart surgical operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Bleeding
- Thrombocyten < 20.000 /µl, INR>3,0
- HIV-Test positive
- Hepatitis C positive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal treatment with the Cytosorb adsorberThe 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. | Device | Cytosorb group |
Primary outcome
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.
4 secondary outcomes
30- and 90-day survival
Time frame: day 30, day 90
time of respirator-therapy
Time frame: day 90
length of ICU stay
Time frame: day 90
dosage of vasopressors on the days 1, 2 and 3.
Time frame: day 1, 2 and 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Sauer, PD Dr. principal investigator
University of Rostock, University Hospital, Intensive Care, Schillingallee 35, 18055 Rostock, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal treatment with the Cytosorb adsorber in people with Multiple Organ Failure, run by University of Rostock at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Sauer, PD Dr. (49 381 4946409, martin.sauer@uni-rostock.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean SOFA (time frame: day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.