NCT02550600

Brief Summary

The purpose of this study is to compare the effect of interventional Lung Assist iLA activve to standard therapy in mechanically ventilated patients with severe acute lung impairment. Hypothesis: iLA(active) reduces the incidence of an increase in SOFA-Score of ≥3 points (or death) within 28 days compared to standard treatment.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
4 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 15, 2015

Status Verified

September 1, 2015

Enrollment Period

1.7 years

First QC Date

July 24, 2015

Last Update Submit

September 11, 2015

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDSAcute lung impairmentExtracorporeal lung assistECMOECLAMurray-scoreSOFA-score

Outcome Measures

Primary Outcomes (1)

  • Incidence of an increase in SOFA-Score ≥3 points or death within 28 days

    28 days

Secondary Outcomes (12)

  • Death or severe disability after 6 months defined as confinement to bed and inability to wash or dress alone

    6 months

  • Mortality

    28 days, 60 days, ICU-stay

  • Ventilator free days

    28 days, ICU stay

  • Single organ failures as assessed by SOFA

    28 days, ICU stay

  • Prediction of outcome (Primary endpoint: Incidence of an increase in SOFA-Score ≥3 points or death within 28 days)

    28 days

  • +7 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention: iLA activve treatment. iLA activve treatment also requires anticoagulation with un-fractionized heparin and pre-defined PTT-goals (45s-60s depending on blood flow).

Procedure: iLA activve treatment

Control group

ACTIVE COMPARATOR

Controls: standard care according to good clinical practice and recent guidelines; no extracorporeal lung assist. For ethical reasons patients of the control group can be treated with iLA activve after fulfilling the primary endpoint criterium of an increase in SOFA ≥3 points. These cross-over patients will be analyzed as controls ("intention to treat").

Procedure: Control group

Interventions

iLA activve treatmentPROCEDURE

iLA activve is aimed at efficient extracorporeal membrane oxygenation with an initial blood flow of ≥2L/min. The length of therapy is at the discretion of the treating physician. Treating physicians are recommended to use a pre-specified algorithm to optimize the extracorporeal lung assist (choice of cannulas and oxygenator, titration of blood flow and sweep gas flow). Primary/mandatory goals are pO2≥65mmHg, P\_peak ≤30cm H2O, TV ≤6ml/kg PBW and pH ≥7.25. Secondary suggested goals are setting the PEEP level within the limits suggested by the ARDSnet low and high PEEP strategy, 35mmHg ≤ pCO2 ≤45mmHg, Delta-pressure (= P\_peak - PEEP) ≤15 cm H2O and P\_peak ≤25 cm H2O. iLA activve treatment also requires anticoagulation with un-fractionized heparin (PTT-goal 45s-60s depending on blood flow).

Also known as: ECMO, Extra-corporeal lung assist
Intervention group
Control groupPROCEDURE

The controls will be treated according to the recent guideline of the German Sepsis Society and the German Interdisciplinary Association of Intensive Care and Emergency Medicine and good clinical practice including lung-protective ventilation with low tidal volume (LTV), moderate hypercapnia, PEEP according to ARDSnet, adjunctive measures (e.g. prone positioning; neuromuscular blockers as appropriate) and treatment of the underlying disease as applied in the experimental group. There will be no sham treatment of iLA activve.in the controls. All adjunctive measures (e.g. prone positioning; neuromuscular blockers as appropriate) are also available for the intervention group.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Potentially reversible lung failure AND
  • Cumulative Murray score ≥6 points without radiological points for a maximum of 48h AND
  • Cumulative Murray score ≥4 points for pO2/FiO and PEEP AND
  • Cumulative Murray score ≥1 point for pO2/FiO
  • Mechanical ventilation for ≤96h AND
  • Age ≥ 18 years.

You may not qualify if:

  • SOFA-Score \>20
  • Life expectancy \<24h
  • mechanical ventilation \>96h
  • Heparin-induced thrombopenia
  • Intracranial bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Medical University of Vienna/General Hospital of Vienna

Vienna, Austria

Location

Klinik für Intensivmedizin; Universitätsklinikum Hamburg-Eppendorf (UKE)

Hamburg, D-20246, Germany

Location

Abteilung für Intensivmedizin; Krankenhaus Barmherzige Brüder; München

Munich, D-80639, Germany

Location

I. Medizinische Klinik; Klinikum rechts der Isar; Technische Universität München

Munich, D-81675, Germany

Location

II. Medizinische Klinik; Klinikum rechts der Isar; Technische Universität München

München, D-81675, Germany

Location

Klinik für Anästhesiologie; Klinikum rechts der Isar; Technische Universität München

München, D-81675, Germany

Location

Department of Anaesthesiology and Intensive Therapy; University of Szeged

Szeged, Hungary

Location

St. Bartholomew's & London Chest Hospitals

London, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Wolfgang Huber, MD

    II. Medizinische Klinik; Klinikum rechts der Isar; Ismaningerstrasse 22; D-81675 München; Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wolfgang Huber, MD

CONTACT

++49-89-4140-5214Wolfgang.Huber@lrz.tum.de

Regina Sommer, Study Nurse

CONTACT

++49-89-4140-5478Regina.Sommer@lrz.tum.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2015

First Posted

September 15, 2015

Study Start

November 1, 2015

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

September 15, 2015

Record last verified: 2015-09

Locations

AU(1)DE(5)GB(1)HU(1)