Last reviewed · How we verify

NCT01913977

Clinical Study to Determine the Optimal Operation Parameters During CO2 Removal With the Abylcap® System

Completed NA Last updated 29 December 2022
What this trial tests

NA trial testing Abylcap® System: blood flow (QB): 200mL/min; gas flow (QG):7L/min in ARDS (Acute Respiratory Distress Syndrome) in 4 participants. Completed in 12 September 2014.

Timeline
20 February 2014
Primary endpoint
13 June 2014
12 September 2014

Quick facts

Lead sponsorUniversity Hospital, Ghent
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment4
Start date20 February 2014
Primary completion13 June 2014
Estimated completion12 September 2014
Sites1 location across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Ghent

Who can join

18 and older, any sex, with ARDS (Acute Respiratory Distress Syndrome) or Respiratory Acidosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This prospective study includes 5 patients with ARDS (Acute Respiratory Distress Syndrome) treated by mechanical ventilation. In case of respiratory acidosis, extracorporeal CO2 (carbon dioxide)removal might be necessary. We hereby work with the Abylcap system with the oxygenator Lilliput2 as CO2 remover (Bellco, Italy). The patients (M/V) are older than 18, not pregnant, have a BMI\<30, and no contraindication for anticoagulation therapy. Under standard conditions patients are treated with a blood flow of QB=300mL/min and a gas flow (100% 02) of QG=7L/min. Blood sampling is performed from the arterial bloodline in the patients at 0, 1h, 3h, 24h, 48h, 72h, 96h, and 120h. A parameter study is also performed to optimise CO2 removal. Herewith, blood samples (1mL) are taken from the inlet and outlet line of the Lilliput2 at the previously mentioned time points and for different flow setting: Blood flow (QB) 200-300-400mL/min and gas flow (QG) 1.5, 3, 6, 7, 8L/min Blood samples are analysed for the different blood gases from which the extraction in the CO2 remover can be calculated for each setting of QB (blood flow) and QG (gas flow).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for ARDS (Acute Respiratory Distress Syndrome)

Currently open trials in the same condition.

Other University Hospital, Ghent trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01913977.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing