APROTININ TREATMENT OF ACUTE RESPIRATORY DISTRESS SYNDROME: A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III TRIAL

Conditions

ACUTE RESPIRATORY DISTRESS SYNDROME

Brief summary

primary efficacy: For the primary endpoint, ventilator-free days (DLVI) will be calculated. A patient will be considered ventilator-free after two consecutive calendar days of unassisted ventilation. These variables will also be assessed at D90 in an exploratory analysis.

Detailed description

secondary efficacy: All-cause mortality will be assessed at D28 (primary) and also at D90 and D180. All deaths will be recorded as EAS up to D180. The location of the patient at the time of death (ICU or hospital) will also be recorded. SOFA, renal support, vasoactive support, respiratory functioning, persistent weakness and neuropsychological disorders (D180)., safety: Adverse Event Evaluation, Causality, Adverse Event in Clinical Laboratory, Adverse Event Recording, Serious Adverse Event Reporting, Adverse Event Follow-Up, Adverse Event Monitoring, laboratory: Blood samples will be taken for biochemistry and hematology at screening, prior to dosing on D1 (baseline) and daily until D28 while the patient is in the ICU., vital signs: - Blood pressure (systolic, diastolic and mean; mmHg): to be recorded through an arterial line. - Heart rate (HR; bpm): measured according to clinical practice in each ICU. - Total respiratory rate (breaths per minute). - Temperature (°C) - ECG

Related papers

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Interventions

DRUGsaline solution

DRUGInhaled aprotenin 200 KIU/mL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
primary efficacy: For the primary endpoint, ventilator-free days (DLVI) will be calculated. A patient will be considered ventilator-free after two consecutive calendar days of unassisted ventilation. These variables will also be assessed at D90 in an exploratory analysis.	—

Secondary

Measure	Time frame
secondary efficacy: All-cause mortality will be assessed at D28 (primary) and also at D90 and D180. All deaths will be recorded as EAS up to D180. The location of the patient at the time of death (ICU or hospital) will also be recorded. SOFA, renal support, vasoactive support, respiratory functioning, persistent weakness and neuropsychological disorders (D180)., safety: Adverse Event Evaluation, Causality, Adverse Event in Clinical Laboratory, Adverse Event Recording, Serious Adverse Event Reporting, Adverse Event Follow-Up, Adverse Event Monitoring, laboratory: Blood samples will be taken for biochemistry and hematology at screening, prior to dosing on D1 (baseline) and daily until D28 while the patient is in the ICU., vital signs: - Blood pressure (systolic, diastolic and mean; mmHg): to be recorded through an arterial line. - Heart rate (HR; bpm): measured according to clinical practice in each ICU. - Total respiratory rate (breaths per minute). - Temperature (°C) - ECG	—

Measure

Time frame

secondary efficacy: All-cause mortality will be assessed at D28 (primary) and also at D90 and D180. All deaths will be recorded as EAS up to D180. The location of the patient at the time of death (ICU or hospital) will also be recorded. SOFA, renal support, vasoactive support, respiratory functioning, persistent weakness and neuropsychological disorders (D180)., safety: Adverse Event Evaluation, Causality, Adverse Event in Clinical Laboratory, Adverse Event Recording, Serious Adverse Event Reporting, Adverse Event Follow-Up, Adverse Event Monitoring, laboratory: Blood samples will be taken for biochemistry and hematology at screening, prior to dosing on D1 (baseline) and daily until D28 while the patient is in the ICU., vital signs: - Blood pressure (systolic, diastolic and mean; mmHg): to be recorded through an arterial line. - Heart rate (HR; bpm): measured according to clinical practice in each ICU. - Total respiratory rate (breaths per minute). - Temperature (°C) - ECG

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Countries

Spain

Outcome results

None listed