Extracorporeal CirculationREMOTENCT03104179
Removal of Cytokines in Patients Undergoing Cardiac Surgery With CPB
A study testing Cytosorb Adsorber in people with Extracorporeal Circulation and Hemofiltration, run by Klinikum Nürnberg at 1 site in Germany.
Trial summary
In a lot of cases during cardiac surgery cardiopulmonary bypass initiates SIRS due to release of cytokines during immunological response. They are induced by different types of inductors ( intrinsic and extrinsic). Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Extracorporeal Circulation, Hemofiltration
- What is being tested?
- Cytosorb Adsorber
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- May 2017to May 2019
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Elective cardiac surgery with CPB
- Signed informed consent
- CPB time > 75 min.
- Comorbidities:
- diabetes mellitus
- CHF, NYHA class 1 and 2
Show all 10Show fewer
- liver dysfunction (1, 2)
- kidney dysfunction (1, 2)
- hypertension
- arteriosclerosis
Who cannot join
- Age < 65 years
- Declined informed consent
- Planed temperature < 32 C
- Emergency surgery
- Preexisting renal replacement therapy
- Preexisting kidney transplantation
Show all 9Show fewer
- Administration of immunosuppressants like steroids
- AIDS with CD 4 < 200/
- Participation in other trials
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum Nürnberg - Nuremberg Hospital
Nuremberg, Bavaria, 90471
Giuseppe Santarpino, MD, +4909113985441, giuseppe.santarpino@klinikum-nuernberg.de
theodor Fischlein, MD, +4909113985441, theodor.fischlein@klinikum-nuernberg.de
About this study
Official title: Removal of Cytokines in Patients Undergoing Cardiac Surgery With CPB (The REMOTE Study)
In a lot of cases during cardiac surgery cardiopulmonary bypass initiates SIRS due to release of cytokines during immunological response.
They are induced by different types of inductors ( intrinsic and extrinsic). High levels of inflammation markers like TNF-a, IL 6 and IL 10 as well as TGF-ß are detectable after 2 hours of surgery.
Read more
Beside the inflammation acute phase parameters like fibrinogen, ferritin are increased. These changes lead to rheology impairments.
These strong reactions lead to dysfunction of different organs possibly culminating in a multi organ failure.
There is a correlation between amounts of cytokines and mortality. Often AKI occurs after CPB with a rate of about 30%. Dysfunctions of organ function are often connected with increased mortality, prolonged mechanical ventilation , septic complications, increased catecholamine dosages and prolonged length of ICU stay.
Use of cytokine adsorption within the extracorporeal circuit during CBP can affect the circulating cytokine levels during and after CPB and lead to a diminished inflammatory response, acute phase reaction as well as reduction of organ failure.
Read the detailed description
In a lot of cases during cardiac surgery cardiopulmonary bypass initiates SIRS due to release of cytokines during immunological response.
They are induced by different types of inductors ( intrinsic and extrinsic). High levels of inflammation markers like TNF-a, IL 6 and IL 10 as well as TGF-ß are detectable after 2 hours of surgery.
Beside the inflammation acute phase parameters like fibrinogen, ferritin are increased. These changes lead to rheology impairments.
These strong reactions lead to dysfunction of different organs possibly culminating in a multi organ failure.
There is a correlation between amounts of cytokines and mortality. Often AKI occurs after CPB with a rate of about 30%. Dysfunctions of organ function are often connected with increased mortality, prolonged mechanical ventilation , septic complications, increased catecholamine dosages and prolonged length of ICU stay.
Use of cytokine adsorption within the extracorporeal circuit during CBP can affect the circulating cytokine levels during and after CPB and lead to a diminished inflammatory response, acute phase reaction as well as reduction of organ failure.
Official Title: Removal of Cytokines in patients undergoing cardiac surgery with CPB ( The REMOTE Study)
Study type: Interventional Study design: randomized, controlled Endpoint Classification: Efficacy study Interventional Model: Parallel assignment Masking: Single blinding ( Subject) Primary purpose: Treatment
Patients who have an elective cardiac surgery with an expected CPB duration > 75 min ( e.g. valve surgery, CABG, combined procedures, redo) will be enrolled into the study after a giving informed consent.
Selection of patients are directed by randomization. Patient which drop out will be replaced.
- Conditions
- Extracorporeal Circulation, Hemofiltration
- Being tested
- Cytosorb Adsorber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytosorb AdsorberDevice
Cytokine adsorption during CPB
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | CPB with Cytosorb Receives: Device: Cytosorb Adsorber |
| Control | No intervention | CPB without Cytosorb (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine levels following CPB
Evaluation of cytokine adsorber effect on cytokine levels intra- and post
Measured: 72 hours
Secondary outcomes (7)
Intra- and postoperative catecholamine dosages
Impact of intraoperative Cytokine adsorption on hemodynamic stability
Measured: until ICU discharge, expected average 4 days
postoperative renal failure necessitating RRT
Impact of intraoperative Cytokine adsorption on postoperative organ function
Measured: until ICU discharge, expected average 4 days
Level of ferritin
Impact of intraoperative Cytokine adsorption on iron metabolism
Measured: 72 hours
Level of transferrin
Impact of intraoperative Cytokine adsorption on iron metabolism
Measured: 72 hours
Level of haptoglobin
Impact of intraoperative Cytokine adsorption on iron metabolism
Measured: 72 hours
Length of ICU stay
Impact of intraoperative Cytokine adsorption on postoperative patient course
Measured: until discharge from ICU, expected average 4 days
Length of hospital stay
Impact of intraoperative Cytokine adsorption on postoperative patient course
Measured: up to hospital discharge, expected average 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study startMay 2017 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal CirculationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinikum Nürnberg
- Sponsor type
- University, hospital or other
- Collaborators
- CytoSorbents, Inc
- Responsible party
- Principal investigator, PD Dr. med. Giuseppe Santarpino, Klinikum Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104179
- Sponsor's protocol ID
- 1_15B
- Acronym
- REMOTE
- Status last verified
- Mar 2017
- First submitted
- 16 Jun 2015
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Levy JH, Tanaka KA. Inflammatory response to cardiopulmonary bypass. Ann Thorac Surg. 2003 Feb;75(2):S715-20. doi: 10.1016/s0003-4975(02)04701-x.
PubMed 12607717Allan CK, Newburger JW, McGrath E, Elder J, Psoinos C, Laussen PC, del Nido PJ, Wypij D, McGowan FX Jr. The relationship between inflammatory activation and clinical outcome after infant cardiopulmonary bypass. Anesth Analg. 2010 Nov;111(5):1244-51. doi: 10.1213/ANE.0b013e3181f333aa. Epub 2010 Sep 9.
PubMed 20829561Bellomo R, Auriemma S, Fabbri A, D'Onofrio A, Katz N, McCullough PA, Ricci Z, Shaw A, Ronco C. The pathophysiology of cardiac surgery-associated acute kidney injury (CSA-AKI). Int J Artif Organs. 2008 Feb;31(2):166-78. doi: 10.1177/039139880803100210.
PubMed 18311733Blomquist S, Gustafsson V, Manolopoulos T, Pierre L. Clinical experience with a novel endotoxin adsorbtion device in patients undergoing cardiac surgery. Perfusion. 2009 Jan;24(1):13-7. doi: 10.1177/0267659109106730.
PubMed 19567543Peng ZY, Wang HZ, Carter MJ, Dileo MV, Bishop JV, Zhou FH, Wen XY, Rimmele T, Singbartl K, Federspiel WJ, Clermont G, Kellum JA. Acute removal of common sepsis mediators does not explain the effects of extracorporeal blood purification in experimental sepsis. Kidney Int. 2012 Feb;81(4):363-9. doi: 10.1038/ki.2011.320. Epub 2011 Sep 14.
PubMed 21918497
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Removal of Cytokines in Patients Undergoing Cardiac Surgery With CPB (The REMOTE Study)
- ClinicalTrials.gov ID
- NCT03104179
- Acronym / sponsor ID
- REMOTE / 1_15B
- Conditions
- Extracorporeal Circulation, Hemofiltration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Klinikum NürnbergUniversity, hospital or other
- Collaborators
- CytoSorbents, Inc
- Study start
- May 2017 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 7 Apr 2017 (actual)
- 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.
In a lot of cases during cardiac surgery cardiopulmonary bypass initiates SIRS due to release of cytokines during immunological response.
They are induced by different types of inductors ( intrinsic and extrinsic). High levels of inflammation markers like TNF-a, IL 6 and IL 10 as well as TGF-ß are detectable after 2 hours of surgery.
Beside the inflammation acute phase parameters like fibrinogen, ferritin are increased. These changes lead to rheology impairments.
These strong reactions lead to dysfunction of different organs possibly culminating in a multi organ failure.
There is a correlation between amounts of cytokines and mortality. Often AKI occurs after CPB with a rate of about 30%. Dysfunctions of organ function are often connected with increased mortality, prolonged mechanical ventilation , septic complications, increased catecholamine dosages and prolonged length of ICU stay.
Use of cytokine adsorption within the extracorporeal circuit during CBP can affect the circulating cytokine levels during and after CPB and lead to a diminished inflammatory response, acute phase reaction as well as reduction of organ failure.
Detailed description
In a lot of cases during cardiac surgery cardiopulmonary bypass initiates SIRS due to release of cytokines during immunological response.
They are induced by different types of inductors ( intrinsic and extrinsic). High levels of inflammation markers like TNF-a, IL 6 and IL 10 as well as TGF-ß are detectable after 2 hours of surgery.
Beside the inflammation acute phase parameters like fibrinogen, ferritin are increased. These changes lead to rheology impairments.
These strong reactions lead to dysfunction of different organs possibly culminating in a multi organ failure.
There is a correlation between amounts of cytokines and mortality. Often AKI occurs after CPB with a rate of about 30%. Dysfunctions of organ function are often connected with increased mortality, prolonged mechanical ventilation , septic complications, increased catecholamine dosages and prolonged length of ICU stay.
Use of cytokine adsorption within the extracorporeal circuit during CBP can affect the circulating cytokine levels during and after CPB and lead to a diminished inflammatory response, acute phase reaction as well as reduction of organ failure.
Official Title: Removal of Cytokines in patients undergoing cardiac surgery with CPB ( The REMOTE Study)
Study type: Interventional Study design: randomized, controlled Endpoint Classification: Efficacy study Interventional Model: Parallel assignment Masking: Single blinding ( Subject) Primary purpose: Treatment
Patients who have an elective cardiac surgery with an expected CPB duration > 75 min ( e.g. valve surgery, CABG, combined procedures, redo) will be enrolled into the study after a giving informed consent.
Selection of patients are directed by randomization. Patient which drop out will be replaced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Cytosorb AdsorberCPB with Cytosorb |
| Control | No intervention | –CPB without Cytosorb (Control) |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Elective cardiac surgery with CPB
- Signed informed consent
- CPB time > 75 min.
- Comorbidities:
- diabetes mellitus
Key exclusion criteria (9 listed)
- Age < 65 years
- Declined informed consent
- Planed temperature < 32 C
- Emergency surgery
- Preexisting renal replacement therapy
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 |
|---|---|---|
| Cytosorb AdsorberCytokine adsorption during CPB | Device | Treatment |
Primary outcome
Cytokine levels following CPB
Time frame: 72 hours
Evaluation of cytokine adsorber effect on cytokine levels intra- and post
7 secondary outcomes
Intra- and postoperative catecholamine dosages
Time frame: until ICU discharge, expected average 4 days
postoperative renal failure necessitating RRT
Time frame: until ICU discharge, expected average 4 days
Level of ferritin
Time frame: 72 hours
Level of transferrin
Time frame: 72 hours
Level of haptoglobin
Time frame: 72 hours
Length of ICU stay
Time frame: until discharge from ICU, expected average 4 days
Length of hospital stay
Time frame: up to hospital discharge, expected average 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Background: PubMed 12607717Levy JH, Tanaka KA. Inflammatory response to cardiopulmonary bypass. Ann Thorac Surg. 2003 Feb;75(2):S715-20. doi: 10.1016/s0003-4975(02)04701-x.
- Background: PubMed 20829561Allan CK, Newburger JW, McGrath E, Elder J, Psoinos C, Laussen PC, del Nido PJ, Wypij D, McGowan FX Jr. The relationship between inflammatory activation and clinical outcome after infant cardiopulmonary bypass. Anesth Analg. 2010 Nov;111(5):1244-51. doi: 10.1213/ANE.0b013e3181f333aa. Epub 2010 Sep 9.
- Background: PubMed 18311733Bellomo R, Auriemma S, Fabbri A, D'Onofrio A, Katz N, McCullough PA, Ricci Z, Shaw A, Ronco C. The pathophysiology of cardiac surgery-associated acute kidney injury (CSA-AKI). Int J Artif Organs. 2008 Feb;31(2):166-78. doi: 10.1177/039139880803100210.
- Background: PubMed 19567543Blomquist S, Gustafsson V, Manolopoulos T, Pierre L. Clinical experience with a novel endotoxin adsorbtion device in patients undergoing cardiac surgery. Perfusion. 2009 Jan;24(1):13-7. doi: 10.1177/0267659109106730.
- Background: PubMed 21918497Peng ZY, Wang HZ, Carter MJ, Dileo MV, Bishop JV, Zhou FH, Wen XY, Rimmele T, Singbartl K, Federspiel WJ, Clermont G, Kellum JA. Acute removal of common sepsis mediators does not explain the effects of extracorporeal blood purification in experimental sepsis. Kidney Int. 2012 Feb;81(4):363-9. doi: 10.1038/ki.2011.320. Epub 2011 Sep 14.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytosorb Adsorber in people with Extracorporeal Circulation and Hemofiltration, run by Klinikum Nürnberg 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 10 inclusion and 9 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 2017. 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 Giuseppe Santarpino, MD (+4909113985441, giuseppe.santarpino@klinikum-nuernberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokine levels following CPB (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03104179, which also lists 5 linked publications.
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 2017.