Safety and Efficacy Evaluation of CO2 Removal in Combination With Continuous Veno-Venous Hemodialysis/Hemodiafiltration Therapy

NCT04871893 | Completed

• 2 other identifiers: CRRT-CVVHD/HDF-01-DCIV-21-03-035951
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 6

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.

Conditions

Acute Lung Injury; Acute Kidney Injury; Hypercapnia; Covid19

Keywords

CO2 removal; Continuous Renal Replacement Therapy; blood-gas exchanger; CRRT; multiECCO2R

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Technical efficiency variables: Change of pCO2

  72 hours after start of treatment

Study Arms (1)

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.

Device: multiECCO2R blood-gas exchanger

Interventions

multiECCO2R blood-gas exchanger DEVICE

Treatment with the blood-gas exchanger multiECCO2R for CO2 removal

Treatment with the blood-gas exchanger multiECCO2R for CO2 removal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Medical Care Deutschland GmbH: lead
• CERES GmbH: collaborator

Study Sites (6)

Universitätsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin

Regensburg, Bavaria, 93053, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Klinikum Donaustauf

Donaustauf, 93093, Germany

Location

Universitätsklinikum Hamburg

Hamburg, 20246, Germany

Location

Klinikum Herford

Herford, 32049, Germany

Location

MeSH Terms

Conditions

Acute Lung Injury; Acute Kidney Injury; Hypercapnia; COVID-19

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, non-comparative, multi-centre, open-label, interventional PMCF study

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 4, 2021
• Study Start: March 25, 2022
• Primary Completion: December 6, 2024
• Study Completion: December 31, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

DE (6)