acute lung injury, ALI/ARDS MedDRA version: 17.1 Level: PT Classification code 10001052 Term: Acute respiratory distress syndrome System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 17.1 Level: PT Classification code 10069351 Term: Acute lung injury System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Enahexal
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Sponsors
Universität Leipzig
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. invasive mechanical ventilation and begin of ventilation dates back a maximum of 60 hours 2. acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) defined by a. sudden beginn of pulmonary failure and b. PaO2/FiO2 = 300 mmHg (ARDS: PaO2/FiO2 = 200 mmHg) and c. bilateral pulmonary shadows apparent on chest x-ray which are conformable with a edema and d. exclusion of a left cardiac insufficiency as source of the edema, i.e. pumonary closing pressure =18mmHg, if measured or absent signs of a clinically manifest left cardiac insufficiency. 3. Age at least 18 years 4. written informed consent by patient or legal or authorized representative Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. positive pregnancy test in women with childbearing potential 2. nursing women 3. unsuggestive of elevatetd intracraniell pressure 4. unsuggestive of neuromuscular diseases, if they are likely to affect spontaneous breathing 5. known sickle cell anaemia 6. severe chronic respiratory insufficiency in pre-existing pulmonary disease 7. severe adiposity > 45 kg/qm 8. burns of more than 30% of the body surface area 9. other medical conditions with an expected 6-months mortality >50% 10. Patients a. after bone marrow- or stem cell transplant in the past 12 months b. lung transplant 11. liver cirrhosis Child Pugh C 12. contraindications following the SmPC except for renal function disorders and renal replacement therapy 13. Participation in another interventional clinical trials 14. advanced relations to investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety concerning renal functions and cardiovascular functions as well as the occurrence of severe adverse events. Further primary objective is efficacy of the treatment regarding the recovery of the lungs measured as ventilator free days.;Secondary Objective: Secondary objectives are: - mortality on day 28 and day 60 after start of trial therapy -state of ventilation on day 28 -organ-failure free days until day 28 -highest SOFA-Score during treatment and max. until day 28 -days outside ICU (until day 28) -changes in oxygenation (PaO2/FiO2) ;Primary end point(s): primary endpoints of safety: - renal replacement therapy free days (RRTFD) until day 28 - chronic renal replacement therapy (RRTc) on day 60 - Change in renal function (CREA) until day 28 (ADDITIONAL endpoint since Amendment 03) - mean fluid balance (mean FB) until day 5 - vasoactive substance free days (VASFD) until day 28 - maximum and mean SOFA-Subscore cardiovascular function (maxSOFA-CV, mean SOFA-CV) until day 28 - vasopressor dose (VD) until day 28 - any serious adverse event primary endpoint of efficacy: - ventilator free days (VFD) until day 28;Timepoint(s) of evaluation of this end point: please see E.5.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. survival on day 28 and day 60 after randomisation (SV) 2. Breathing without assistance (BWA), this efficacy end point is measured in two variants: a. proportion of patients breathing with assistance (on day 28) and alive on day 28 b. proportion of patients breathing with assistance (on day 28) and who died and who are evaluable (according to trial protocol) ;Timepoint(s) of evaluation of this end point: please see E.5.2 | — |
Countries
Germany
Contacts
Public ContactAbteilung für Pneumologie
Universität Leipzig, Department für Innere Medizin, Neurologie und Dermatologie
Outcome results
None listed