- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04871893
Safety and Efficacy Evaluation of CO2 Removal in Combination With Continuous Veno-Venous Hemodialysis/Hemodiafiltration Therapy (multiECCO2R)
Safety and Effcacy Evaluation of CO2 Removal in Combination With Continuous Veno-Venous Hemodialysis/Hemodiafiltration Therapy (A Clinical Study in Patients With Combined Renal Failure and Hypercapnia Due to Acute Lung Failure in COVID-19 and Other Forms of Respiratory Insufficiency)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Manuela Stauss-Grabo, Dr.
- Phone Number: +49 6172 608 5248
- Email: Manuela.Stauss-Grabo@fmc-ag.com
Study Contact Backup
- Name: Anna Wammi
- Phone Number: +49 6172 609 7634
- Email: anna.wammi@fmc-ag.com
Study Locations
-
-
-
Berlin, Germany, 10117
- Recruiting
- Charité - Universitätsmedizin Berlin
-
Contact:
- Philipp Enghard, Dr. med.
- Email: Philipp.Enghard@Charite.de
-
Donaustauf, Germany, 93093
- Recruiting
- Klinikum Donaustauf
-
Contact:
- Stefan Blaas, Dr.
- Email: Studienzentrum@klinikum-donaustauf.de
-
Hamburg, Germany, 20246
- Recruiting
- Universitatsklinikum Hamburg
-
Contact:
- Stefan Kluge, Prof.Dr.
- Email: s.kluge@uke.de
-
Herford, Germany, 32049
- Recruiting
- Klinikum Herford
-
Contact:
- Jan Kähler, Prof. Dr.
- Email: jan.kaehler@klinikum-herford.de
-
-
Bayern
-
Erlangen, Bayern, Germany, 91054
- Recruiting
- Universitätsklinikum Erlangen
-
Contact:
- Carsten Willam, Dr
- Phone Number: +49 9131 85 39240
- Email: Carsten.willam@uk-erlangen.de
-
Regensburg, Bayern, Germany, 93053
- Recruiting
- Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin
-
Contact:
- Matthias Lubnov, Dr.
- Phone Number: +49 941 944 17356
- Email: Matthias.Lubnow@klinik.uni-regensburg.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Informed consent signed and dated by the investigator; and:
- if patient is able to give consent: by the study patient
- if patient is unable to give consent: by the legal representative or
- if an emergency situation is determined: by an independent consultant physician
- Minimum age of 18 years
Study-specific:
- Body weight greater than 40 kg
- Acute Kidney Injury (AKI) with clinical indication for CRRT
- Hypercapnia with indication for ECCO2R:
(paCO2 ≥ 55 mmHg at given best possible protective ventilation parameters: Guiding parameters: tidal volume = 6 ml/kg PBW, PEEP to be adjusted according to the FiO2 1, driving pressure < 15 cmH2O, max. inspiratory pressure < 30 cmH2O or TV<=5 ml/kg when max. inspiratory pressure< 30 cmH2O cannot be held)
- Vascular access and Shaldon catheter allowing blood flow of 100 ml/min to 500 ml/min
- Arterial line in place, allowing blood sampling
- Estimated life expectancy greater than 3 days
Exclusion Criteria:
- In case of female patients: pregnancy or lactation period (if patient is ≥ 55 years old or have been surgically sterilized, a negative pregnancy test is not required)
- Participation in an interventional clinical study during the preceding 72 hours
- Previous participation in the same study
Study-specific
- Severe ARDS (Berlin definition): PaO2/FiO2 < 100 mmHg
- Intracerebral haemorrhage
- Intracranial hypertension
- Acute myocardial infarction
- Hypersensitivity to heparin or known history of heparin induced thrombocytopenia (HIT Type II), if heparin is used as anticoagulant
- severe liver insufficiency or fulminant hepatic failure
- Uncontrolled bleeding and coagulation disorders, thrombocytopenia < 75000µL
- Liver cirrhosis CHILD Pugh Classification > A
- BMI > 40 kg/m²
- Decision to limit therapeutic interventions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Treatment with the blood-gas exchanger multiECCO2R for CO2 removal
Treatment of patients suffering from hypercapnia due to acute lung failure and acute kidney injury (AKI).
Patients will be treated up to 72 hours with CVVHD/HDF with a standard multiFiltrate blood line kit (multiFiltrate or multiFiltrate Pro).
In order to perform an ECCO2R procedure during CVVHD/HDF treatment, the blood-gas exchanger multiECCO2R is inserted in a specifically designed blood line kit downstream of the hemodialyzer.
|
Treatment with the blood-gas exchanger multiECCO2R for CO2 removal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical efficiency variables: Change of PaCO2
Time Frame: 30 minutes after start of treatment
|
Change of PaCO2 during the first 30 minutes of treatment (Blood-gas analysis (BGA))
|
30 minutes after start of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Technical efficiency variables: Change of pCO2
Time Frame: 72 hours after start of treatment
|
Change of pCO2 within the extracorporeal circuit by pre- and post- CO2-exchanger during the treatment (Blood-gas analysis (BGA))
|
72 hours after start of treatment
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Thomas Müller, Prof. Dr., Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin
- Principal Investigator: Matthias Lubnow, Dr. med., Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Kidney Diseases
- Urologic Diseases
- Renal Insufficiency
- Signs and Symptoms, Respiratory
- Thoracic Injuries
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- COVID-19
- Wounds and Injuries
- Acute Kidney Injury
- Acute Lung Injury
- Lung Injury
- Hypercapnia
Other Study ID Numbers
- CRRT-CVVHD/HDF-01-D
- CIV-21-03-035951 (Other Identifier: Unique identification number EUDAMED)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Covid19
-
Anavasi DiagnosticsNot yet recruiting
-
Ain Shams UniversityRecruiting
-
Israel Institute for Biological Research (IIBR)Completed
-
Colgate PalmoliveCompleted
-
Christian von BuchwaldCompleted
-
Luye Pharma Group Ltd.Shandong Boan Biotechnology Co., LtdActive, not recruiting
-
University of ZurichLabor Speiz; Swiss Armed Forces; Universitätsspital ZürichEnrolling by invitation
-
Alexandria UniversityCompleted
-
Erasmus Medical CenterUniversity Medical Center Groningen; Academisch Medisch Centrum - Universiteit... and other collaboratorsRecruiting
Clinical Trials on multiECCO2R blood-gas exchanger
-
University of Erlangen-Nürnberg Medical SchoolUniversitätsklinikum Hamburg-Eppendorf; University Hospital FrankfurtCompleted
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Soroka University Medical CenterLoyola University, Harel Dahari, PhD, mathematical modeling supportCompleted
-
Kanuni Sultan Suleyman Training and Research HospitalCompletedRespiratory Distress Syndrome | Transient Tachypnea of Newborn
-
Ayham DaherRecruiting
-
MemorialCare Health SystemCompleted
-
Rabin Medical CenterCompletedLung Diseases | Desaturation of BloodIsrael
-
Christiana Care Health ServicesCompletedPatients Needing Blood GasesUnited States
-
Akdeniz UniversityCompletedHyperoxia | Kidney Transplant; Complications | Graft DysfunctionTurkey
-
Olive View-UCLA Education & Research InstituteCompleted