Clinical trial NCT04871893: Safety and Efficacy Evaluation of CO2 Removal in Combination With Continuous Veno-Venous Hemodialysis/Hemodiafiltration Therapy
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lung Injury
Acute Kidney Injury
Hypercapnia
Covid19
Keywords: CO2 removal
Continuous Renal Replacement Therapy
blood-gas exchanger
CRRT
multiECCO2R
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
Collaborators: name: CERES GmbH
First posted: 2021-05-04
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-comparative, multi-centre, open-label, interventional PMCF study
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Informed consent signed and dated by the investigator; and:

  1. if patient is able to give consent: by the study patient
  2. if patient is unable to give consent: by the legal representative or
  3. 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

Primary outcomes:
measure: Clinical efficiency variables: Change of PaCO2
timeFrame: 30 minutes after start of treatment
Secondary outcomes:
measure: Technical efficiency variables: Change of pCO2
timeFrame: 72 hours after start of treatment
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
state: Bayern
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin
state: Bayern
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Donaustauf
country: Germany
facility: Klinikum Donaustauf
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg
city: Herford
country: Germany
facility: Klinikum Herford
Study officials:
affiliation: Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin
name: Thomas Müller, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin
name: Matthias Lubnow, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: