SURFACEN in ARDS. Adults. Phase IV

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000198
• Date of registration: 24/06/2015
• Prospective Registration: No
• Primary sponsor: National Centre of Animal and Plants Health (CENSA)
• Public title: SURFACEN in ARDS. Adults. Phase IV
• Scientific title: Evaluation of the safety and effectiveness of SURFACEN, in combination with conventional therapy in the treatment of acute respiratory distress syndrome in adults. National extension.
• Date of first enrolment: 22/07/2013
• Target sample size: 184
• Recruitment status: Recruiting
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000198-En
• Study type: Interventional
• Study design: Allocation: N/A: single arm study. Masking: Open. Control group: Uncontrolled. Assignment: Single group. Purpose: Treatment
• Phase: 4

Countries of recruitment

Cuba

Contacts

• Name: Nora Lim Alonso
• Affiliation: Hospital “Hermanos Ameijeiras"

• Name: Yisel Avila Albuerne
• Affiliation: National Coordinating Center of Clinical Trials (CENCEC)

Key inclusion & exclusion criteria

Inclusion criteria: 1. Diagnosis of ARDS, according to the new definition of ARDS Berlin
2. Patient or member family frontline which expresses voluntariness written entering the study by signing the informed voluntary consent
3. 18 years and older.
Exclusion criteria: 1. Pregnant and postpartum women
2. Chronic obstructive pulmonary disease (COPD).
3. Patient at the time of inclusion is receiving other investigational drug.
4. Prior knowledge of a known allergy or sensitivity to SURFACEN® or any component of the formulation.

Age minimum: 18 years
Age maximum: None
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Acute Respiratory Distress Syndrome

Intervention(s)

Experimental group: SURFACEN® + oxygenation + mechanical ventilation. Administration of 100 mg (4 mL) of SURFACEN® be indicated endotracheally (instillation through a tube) every 8 hours for a maximum of three days, that is, manage no more than 9 doses.

Primary Outcome(s)

Serious adverse events in relation to the causality (Serious AE with definite, very likely or likely causal relationship). Measuring time: first hour after the 1st dose until to 28 days

Secondary Outcome(s)

Related to safety. Adverse Events (AE). Measuring time: An hour after first dose until 28 days.
- Type of AE (Name of event)
- Time to occurrence of AE (hours, minutes or days, between product administration and the occurrence of AE)
- Duration of the AE (hours, minutes or day that is present the AE)
- Severity/Seriousness of the AE (Serious, Not serious)
- Intensity of the AE (Mild, Moderate, Severe)
- Causality relationship (Definitive, Very likely, Likely, Possible, Unrelated, Unknown)
- Attitude (Without change, Temporary stop, Permanent stop)
- Treatment of the AE (Treatment for the AE).
- Result of the AE (Reversible effect, Irreversible effect, Death, or Loss to follow-up the patient).
- Lot of SURFACEN® (batch number of the product)

Related to effectiveness
Changes in PaO2/FiO2 (value provided by the Blood gas analyzer of Intensive Care Unit-ICU). Measuring time: at baseline, an hour after each dose.
pH (Value provided by the Blood gas analyzer of ICU). Measuring time: at baseline, an hour after each dose.
DA-aO2 (value calculated from the formula [Fi O2 (PB-PH 2 O) -PaCO2] -PaO2 where PB = 760mmHg, PH 2 O = 47mmHg, taking into account normal PaCO2 references (35-48 mmHg (4.7 - 6.4 kPa) men 32-45 mmHg (4.3 - 6.0 kPa) women), PaO2 83-108 mmHg and pH 7.35-7.45). Measuring time: at baseline, an hour after each dose.
Ventilatory mode (pressure, volume). Measuring time: at baseline, an hour after each dose.
Tidal volume (Vt L / min given by the ventilator available in the ICU). Measuring time: at baseline, an hour after each dose.
Respiratory Rate (RR in minutes (min), given by the ventilator in the ICU). Measuring time: at baseline, an hour after each dose.
Peak pressure (Pr cmH2O peak given by the ventilator in the ICU). Measuring time: at baseline, an hour after each dose.
Airway Plateau Pressure (PPlat in cmH2O given by the ventilator in the ICU). Measuring time: at baseline, an hour after each dose.
Relationship inspiration / expiration (I / E, given by the ventilator in the ICU setting). Measuring time: at baseline, an hour after each dose.
PEEP (value in cmH2O given by the ventilator in the ICU, considering ranges 6-10, 11-15, 16-20, over 20). Measuring time: at baseline, an hour after each dose.
Static lung compliance (Cs, calculated from Vt/(Pplat-PEEP) value). Measuring time: at baseline, an hour after each dose.
Alveolar recruitment maneuver (Yes, No). Measuring time: at baseline, an hour after each dose.
Duration of mechanical ventilation (days and hours, from the difference between the dates and times of beginning and end of mechanical ventilation). Measuring time: at baseline, an hour after each dose.
Mechanical ventilation time (days and hours, from the difference between ICU stay and duration of mechanical ventilation) ventilation. Measuring time: at baseline, an hour after each dose.
Blood pressure (BP, value of systolic and diastolic in mmHg). Measuring time: at baseline, an hour after each dose.
Heart rate (HR, min value). Measuring time: at baseline, an hour after each dose.
Central venous pressure (CVP, value cmH2O). Measuring time: at baseline, an hour after each dose.
Temperature (T, value in Celsius grade). Measuring time: at baseline, an hour after each dose.
Cyanosis (Absence, distal cyanosis, generalized cyanosis). Measuring time: at baseline, an hour after each dose.
Inflammatory infiltrates in the lung fields (Improvement, Stabilization, Worsening). Measuring time: at baseline, at 24, 48, 72, 96 and 120 hours of starting treatment.
Time in the ICU (Days and hours from the difference between the dates and times of entry and exit of the ICU patient). Measuring time: at discharge from the ICU.
Patient status at the egress from the ICU (Alive, Death). Measuring time: at discharge from the ICU.
Patient status at 28 days (Alive, Death). Measuring time: 28 days.
Diagnostic Survival (Difference in days between the diagnosis of ARDS date and death of the patient, when the patient dies). Measuring time: 28 days.
Inclusion Survival (Difference in days between the starting treatment date and death of the patient, when the patient dies). Measuring time: 28 days.

Secondary ID(s)

SU9449

Source(s) of Monetary Support

National Center for Animal and Plant Health (CENSA) Cuban Ministry of Public Health (MINSAP)

Secondary Sponsor(s)

Not applicable