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ECMOsorb Trial - Impact of a VA-ECMO in Combination With CytoSorb in Critically Ill Patients With Cardiogenic Shock (ECMOsorb)

Primary Purpose

Cardiogenic Shock

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CytoSorb
VA-ECMO only
Sponsored by
Christian Schulze
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiogenic Shock focused on measuring cardiogenic shock, VA-ECMO, venous arterial Extracorporeal Membrane Oxygenation, inotropic score, extracorporeal cytokine hemadsorption system, cytokine adsorber, intensive care, multi organ failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cardiogenic shock of any cause and indication for VA-ECMO
  • Age between 18 and 80
  • Signed informed consent

Exclusion Criteria:

  • Current participation in another interventional trial
  • Pregnancy
  • Current immunosuppressive or immunomodulatory therapy
  • Contraindications to VA-ECMO implantation.
  • Patients with pre - existing sepsis (raised CPR, positive PCT, leukozytosis, fever, positive blood cultures).
  • Shock duration> 12 h before evaluation.
  • Severe PVD (peripheral vessel disease) making ECMO-implantation impossible.
  • Aortic valve insufficiency / stenosis at least II °.
  • Age > 80 years.
  • CNS disease with fixed, dilated pupils (not drug-induced).
  • Severe concomitant disease with limited life expectancy <6 months.
  • CPR> 60min.
  • Shock due to other reasons
  • HIT positive (Heparin induced thrombocytopenia)
  • Very low platelet counts (< 20,000/µl)
  • Body weight less than 45 kg

Sites / Locations

  • Jena University Hospital, Department of CardiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VA-ECMO and CytoSorb

VA-ECMO only

Arm Description

standard ICU care WITH CytoSorb

standard ICU care WITHOUT CytoSorb

Outcomes

Primary Outcome Measures

Change in inotropic score after 72h (difference between the two study groups)
Inotropic Score: dopamine dose [μg/kg/min] + dobutamine dose [μg/kg/min] + 100x epinephrine dose [μg/kg/min] + 100x norepinephrine [μg/kg/min]

Secondary Outcome Measures

Interleukin 6
pg/ml
Procalcitonin
ng/ml
c-reactive protein
mg/l
lactate
mmol/l
creatinine
µmol/l
glomerular filtration rate (GFR)
ml/min
troponin
pg/ml
creatinine kinase
µmol/l*s
myoglobine
µg/l
urinary output
ml/h
neuron specific enolase
µg/l
s-100
µg/l
cystatin c
mg/l
galectin-3
ng/ml
Duration of: renal replacement therapy (CVVHD), mechanical ventilation, ECMO therapy, inotropic /vasopressor treatment
hours
30 day, ICU and in-hospital mortality
nominal scale (yes/no)
Length of stay in ICU and total length of hospital stay until discharge/transfer
hours
Necessary Implantation of an Active Assist Device or heart transplantation
nominal scale (yes/no)
SAPS II
Simplified Acute Physiology Score II (Minimum value: 0 / maximum value: 163; higher values means worse outcome)
APACHE II score
Acute Pysiology and Chronic Health Evaluation II (Minimum value: 0 / maximum value: 71; higher values means worse outcome)
SOFA score
Sequential Organ Failure Assessment Score (Minimum value: 0 / maximum value: 24; higher value means worse outcome)
cerebreal performance category (CPC)
CPC 1 (adequate function) to CPC 5 (brain dead)
Glasgow coma scale (GCS)
Assessment scheme for disorders of consciousness and brain function (eyes, verbal, motor); scale from 3 (severe impairment) to 15 points (no abnormalities)
EuroQuol 5D-3L Descriptive System
mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.
EQ VAS
EQ visual analogue scale (EQ VAS), patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.
Modified Rankin scale
scale from 0 (no symptoms) to 6 (dead);
Measurement of right ventricular parameters
measurements of right ventricular function in the echo (TAPSE in mm; FAC in %; RVEDD in mm; sPAP in mmHg; RA area in cm²; TASV in cm/s; ICV in mm)
Measurement of left ventricular parameters
measurements of left ventricular function in the echo (LVEDD in mm; LVESD in mm; LVEF in %; VSD (yes/no); LVEDV in ml; LVESV in ml; GLS in %; LA volume in ml)
Measurement of kidney injury and kidney function
NGAL, KIM-1, L-FABP, IGFBP7 in ng/ml
Interleukin 18
pg/ml
incidence of apoplexy
nominal scale (yes/no)
mean arterial pressure
mmHg
central venous oxygen saturation
in %
mixed venous oxygen saturation
in %
arterial oxygen saturation
in %
heart failure re-hospitalisation
nominal scale (yes/no)
Brain natriuretic peptide (BNP)
pg/ml
n-terminal pro brain natriuretic peptide (NT-proBNP)
pg/ml

Full Information

First Posted
March 12, 2021
Last Updated
May 24, 2023
Sponsor
Christian Schulze
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1. Study Identification

Unique Protocol Identification Number
NCT05027529
Brief Title
ECMOsorb Trial - Impact of a VA-ECMO in Combination With CytoSorb in Critically Ill Patients With Cardiogenic Shock
Acronym
ECMOsorb
Official Title
ECMOsorb Trial - Impact of a VA-ECMO in Combination With CytoSorb in Critically Ill Patients With Cardiogenic Shock- A Prospective, Randomized, Blinded, Monocenter Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christian Schulze

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In the ECMOsorb study the impact of a veno-arterial -ECMO in combination with an extracorporeal cytokine hemadsorption system in critically ill patients with cardiogenic shock is to be examined
Detailed Description
The prospective, interventional, randomised controlled and blinded ECMOsorb study investigates in critically ill patinets with cardiogenic shock and with veno-arterial ECMO (VA-ECMO) treatment the impact of an extracorporeal cytokin hemadsorption system on hemodynamics, defined by the Inotropic Score 72 hours after initiation of the adsorber (intervention) or normal ECMO tube (control) in the VA-ECMO.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiogenic Shock
Keywords
cardiogenic shock, VA-ECMO, venous arterial Extracorporeal Membrane Oxygenation, inotropic score, extracorporeal cytokine hemadsorption system, cytokine adsorber, intensive care, multi organ failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, randomized, controlled, blinded, monocenter trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
masking by using a "black-box"; the control group only receives a regular ECMO tube
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VA-ECMO and CytoSorb
Arm Type
Experimental
Arm Description
standard ICU care WITH CytoSorb
Arm Title
VA-ECMO only
Arm Type
Placebo Comparator
Arm Description
standard ICU care WITHOUT CytoSorb
Intervention Type
Device
Intervention Name(s)
CytoSorb
Other Intervention Name(s)
Standard ICU care (with VA-ECMO) AND CytoSorb Adsorber
Intervention Description
An extracorporeal cytokine hemoadsorption system is integrated in the VA-ECMO circuit
Intervention Type
Other
Intervention Name(s)
VA-ECMO only
Other Intervention Name(s)
Standard ICU care (with VA-ECMO)
Intervention Description
only VA-ECMO; NO extracorporeal cytokine hemoadsorption system is added
Primary Outcome Measure Information:
Title
Change in inotropic score after 72h (difference between the two study groups)
Description
Inotropic Score: dopamine dose [μg/kg/min] + dobutamine dose [μg/kg/min] + 100x epinephrine dose [μg/kg/min] + 100x norepinephrine [μg/kg/min]
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Interleukin 6
Description
pg/ml
Time Frame
0 to 7 days after beginning of intervention
Title
Procalcitonin
Description
ng/ml
Time Frame
0 to 7 days after beginning of intervention
Title
c-reactive protein
Description
mg/l
Time Frame
0 to 7 days after beginning of intervention
Title
lactate
Description
mmol/l
Time Frame
0 to 7 days after beginning of intervention
Title
creatinine
Description
µmol/l
Time Frame
0 to 7 days after beginning of intervention
Title
glomerular filtration rate (GFR)
Description
ml/min
Time Frame
0 to 7 days after beginning of intervention
Title
troponin
Description
pg/ml
Time Frame
0 to 7 days after beginning of intervention
Title
creatinine kinase
Description
µmol/l*s
Time Frame
0 to 7 days after beginning of intervention
Title
myoglobine
Description
µg/l
Time Frame
0 to 7 days after beginning of intervention
Title
urinary output
Description
ml/h
Time Frame
0 to 7 days after beginning of intervention
Title
neuron specific enolase
Description
µg/l
Time Frame
0 to 7 days after beginning of intervention
Title
s-100
Description
µg/l
Time Frame
0 to 7 days after beginning of intervention
Title
cystatin c
Description
mg/l
Time Frame
0 to 7 days after beginning of intervention
Title
galectin-3
Description
ng/ml
Time Frame
0 to 7 days after beginning of intervention
Title
Duration of: renal replacement therapy (CVVHD), mechanical ventilation, ECMO therapy, inotropic /vasopressor treatment
Description
hours
Time Frame
day 30 after beginning of intervention
Title
30 day, ICU and in-hospital mortality
Description
nominal scale (yes/no)
Time Frame
day 30 after beginning of intervention
Title
Length of stay in ICU and total length of hospital stay until discharge/transfer
Description
hours
Time Frame
day 30 after beginning of intervention
Title
Necessary Implantation of an Active Assist Device or heart transplantation
Description
nominal scale (yes/no)
Time Frame
day 30 after beginning of intervention
Title
SAPS II
Description
Simplified Acute Physiology Score II (Minimum value: 0 / maximum value: 163; higher values means worse outcome)
Time Frame
0 to 7 days after beginning of intervention
Title
APACHE II score
Description
Acute Pysiology and Chronic Health Evaluation II (Minimum value: 0 / maximum value: 71; higher values means worse outcome)
Time Frame
0 to 7 days after beginning of intervention
Title
SOFA score
Description
Sequential Organ Failure Assessment Score (Minimum value: 0 / maximum value: 24; higher value means worse outcome)
Time Frame
0 to 7 days after beginning of intervention
Title
cerebreal performance category (CPC)
Description
CPC 1 (adequate function) to CPC 5 (brain dead)
Time Frame
0 to 30 days after beginning of intervention
Title
Glasgow coma scale (GCS)
Description
Assessment scheme for disorders of consciousness and brain function (eyes, verbal, motor); scale from 3 (severe impairment) to 15 points (no abnormalities)
Time Frame
0 to 30 days after beginning of intervention
Title
EuroQuol 5D-3L Descriptive System
Description
mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.
Time Frame
7 to 30 days after beginning of intervention
Title
EQ VAS
Description
EQ visual analogue scale (EQ VAS), patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.
Time Frame
7 to 30 days after beginning of intervention
Title
Modified Rankin scale
Description
scale from 0 (no symptoms) to 6 (dead);
Time Frame
0 to 30 days after beginning of intervention
Title
Measurement of right ventricular parameters
Description
measurements of right ventricular function in the echo (TAPSE in mm; FAC in %; RVEDD in mm; sPAP in mmHg; RA area in cm²; TASV in cm/s; ICV in mm)
Time Frame
0 to 7 days after beginning of intervention
Title
Measurement of left ventricular parameters
Description
measurements of left ventricular function in the echo (LVEDD in mm; LVESD in mm; LVEF in %; VSD (yes/no); LVEDV in ml; LVESV in ml; GLS in %; LA volume in ml)
Time Frame
0 to 7 days after beginning of intervention
Title
Measurement of kidney injury and kidney function
Description
NGAL, KIM-1, L-FABP, IGFBP7 in ng/ml
Time Frame
0 to 7 days after beginning of intervention
Title
Interleukin 18
Description
pg/ml
Time Frame
0 to 7 days after beginning of intervention
Title
incidence of apoplexy
Description
nominal scale (yes/no)
Time Frame
30 days after beginning of intervention
Title
mean arterial pressure
Description
mmHg
Time Frame
0 to 7 days after beginning of intervention
Title
central venous oxygen saturation
Description
in %
Time Frame
0 to 7 days after beginning of intervention
Title
mixed venous oxygen saturation
Description
in %
Time Frame
0 to 7 days after beginning of intervention
Title
arterial oxygen saturation
Description
in %
Time Frame
0 to 7 days after beginning of intervention
Title
heart failure re-hospitalisation
Description
nominal scale (yes/no)
Time Frame
30 days after beginning of intervention
Title
Brain natriuretic peptide (BNP)
Description
pg/ml
Time Frame
0 to 7 days after beginning of intervention
Title
n-terminal pro brain natriuretic peptide (NT-proBNP)
Description
pg/ml
Time Frame
0 to 7 days after beginning of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cardiogenic shock of any cause and indication for VA-ECMO Age between 18 and 80 Signed informed consent Exclusion Criteria: Current participation in another interventional trial Pregnancy Current immunosuppressive or immunomodulatory therapy Contraindications to VA-ECMO implantation. Patients with pre - existing sepsis (raised CPR, positive PCT, leukozytosis, fever, positive blood cultures). Shock duration> 12 h before evaluation. Severe PVD (peripheral vessel disease) making ECMO-implantation impossible. Aortic valve insufficiency / stenosis at least II °. Age > 80 years. CNS disease with fixed, dilated pupils (not drug-induced). Severe concomitant disease with limited life expectancy <6 months. CPR> 60min. Shock due to other reasons HIT positive (Heparin induced thrombocytopenia) Very low platelet counts (< 20,000/µl) Body weight less than 45 kg
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Schulze, Prof.
Phone
004936419324100
Email
Christian.Schulze@med.uni-jena.de
First Name & Middle Initial & Last Name or Official Title & Degree
Franz Haertel, Dr.
Phone
004936419324554
Email
Franz.Haertel@med.uni-jena.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Schulze, Prof.
Organizational Affiliation
Jena University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Jena University Hospital, Department of Cardiology
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Schulze, Prof.
Phone
+4936419324100
Email
Christian.Schulze@med.uni-jena.de
First Name & Middle Initial & Last Name & Degree
Franz Haertel, Dr.
Phone
+4936419324554
Email
Franz.Haertel@med.uni-jena.de

12. IPD Sharing Statement

Learn more about this trial

ECMOsorb Trial - Impact of a VA-ECMO in Combination With CytoSorb in Critically Ill Patients With Cardiogenic Shock

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