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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-21-03-035951 | Other Identifier | Unique identification number EUDAMED |
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| Name | Class |
|---|---|
| CERES GmbH | INDUSTRY |
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Objective of the study is to assess the safety and efficacy of CO2 removal by the multiECCO2R (CO2 Removal System) on the multiFiltrate/multiFiltrate Pro in veno-venous extracorporeal circulation during continuous renal replacement therapy (CRRT) in patients presenting with hypercapnia due to acute lung failure and acute kidney injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with the blood-gas exchanger multiECCO2R for CO2 removal | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multiECCO2R blood-gas exchanger | Device | Treatment with the blood-gas exchanger multiECCO2R for CO2 removal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical efficiency variables: Change of PaCO2 | Change of PaCO2 during the first 30 minutes of treatment (Blood-gas analysis (BGA)) | 30 minutes after start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Technical efficiency variables: Change of pCO2 | 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 |
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Inclusion Criteria:
Informed consent signed and dated by the investigator; and:
Minimum age of 18 years
Study-specific:
(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)
Exclusion Criteria:
Study-specific
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Müller, Prof. Dr. | Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin | Study Director |
| Matthias Lubnow, Dr. med. | Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Erlangen | Erlangen | Bavaria | 91054 | Germany | ||
| Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin |
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Prospective, non-comparative, multi-centre, open-label, interventional PMCF study
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| Regensburg |
| Bavaria |
| 93053 |
| Germany |
| Charité - Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| Klinikum Donaustauf | Donaustauf | 93093 | Germany |
| Universitätsklinikum Hamburg | Hamburg | 20246 | Germany |
| Klinikum Herford | Herford | 32049 | Germany |
| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| D058186 | Acute Kidney Injury |
| D006935 | Hypercapnia |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
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