Phase
Condition
Kidney Failure
Lung Injury
Acute Respiratory Distress Syndrome (Ards)
Treatment
multiECCO2R blood-gas exchanger
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
Exclusion Criteria:
In case of female patients: pregnancy or lactation period (if patient is ≥ 55 yearsold 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 Design
Connect with a study center
Universitätsklinikum Erlangen
Erlangen, Bayern 91054
GermanySite Not Available
Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin
Regensburg, Bayern 93053
GermanySite Not Available
Charité - Universitätsmedizin Berlin
Berlin, 10117
GermanySite Not Available
Klinikum Donaustauf
Donaustauf, 93093
GermanySite Not Available
Universitätsklinikum Hamburg
Hamburg, 20246
GermanySite Not Available
Klinikum Herford
Herford, 32049
GermanySite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.