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NCT01913977
Clinical Study to Determine the Optimal Operation Parameters During CO2 Removal With the Abylcap® System
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.
13 June 2014
Quick facts
| Lead sponsor | University Hospital, Ghent |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 4 |
| Start date | 20 February 2014 |
| Primary completion | 13 June 2014 |
| Estimated completion | 12 September 2014 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Abylcap® System: blood flow (QB): 200mL/min; gas flow (QG):7L/min
- Abylcap® System: blood flow (QB): 300mL/min; gas flow (QG):7L/min
- Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):7L/min
- Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):1.5L/min
- Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):3L/min
- Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):6L/min
- Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):8L/min
Conditions studied
- ARDS (Acute Respiratory Distress Syndrome) — all drugs for ARDS (Acute Respiratory Distress Syndrome) →
- Respiratory Acidosis — all drugs for Respiratory Acidosis →
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:
- PubMed search for NCT01913977
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University Hospital, Ghent trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01913977 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Ghent
- Last refreshed: 29 December 2022
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.
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