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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-25

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Uremic Toxins Clearance With Expanded Hemodialysis

NCT04786535

End Stage Renal Disease

UNKNOWN NA

The Effect of Continuous Renal Replacement Therapy on the Efficiency of Extracorporeal CO2 Removal

NCT05989971

Respiratory Failure With Hypercapnia

COMPLETED

Effect of Hemodiafiltration Plus MCOs on Uremic Toxins Removal

NCT03938285

Hemodiafiltration Chronic Kidney Disease Requiring Chronic Dialysis

UNKNOWN NA

Reduction Ratio and Clearance During Hemodialysis With MCO-filter Compared to HDF With Standard High-flux Filter

NCT03437538

Chronic Kidney Failure Uremia Dialysis

COMPLETED NA

Toxins Removal and Inflammatory State modulAtion During Online Hemodiafiltration: Comparison of Two Different Dialyzers

NCT04554498

Hemodialysis Complication Inflammation Uremic; Toxemia

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Lung Injury Acute Kidney Injury Hypercapnia Covid19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

multiECCO2R blood-gas exchanger

Intervention Type DEVICE

Treatment with the blood-gas exchanger multiECCO2R for CO2 removal

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

multiECCO2R blood-gas exchanger

Treatment with the blood-gas exchanger multiECCO2R for CO2 removal

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No