SURFACEN in ARDS Adults. Phase II

Evaluation of the effect and safety of SURFACEN in the treatment of acute respiratory distress syndrome in adults

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000126

Enrollment

Registered

2012-04-11

Start date

2006-03-21

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome in adults

Interventions

Group A (Study): Conventional treatment of oxygenation and mechanical ventilation + Surfacen 100 mg (4 mL) every 8 hours for 3 days. Group B (Control): Conventional treatment of oxygenation and mechan

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Presenceof ARDS inthe first 24hours ofdiagnosis, diagnostic criteriagivenabove. 2. PEEP> 5 cm H2O. 3. Patientswhose relativesgive theirwritten consentto participatein the study. 4. Age between 18 and 75,inclusive.

Exclusion criteria

Exclusion criteria: 1.Pregnant women, breast feedingor post partum. 2.Chronic Obstructive Pulmonary Disease(COPD). 3.Hipersensibilidad to SURFACEN or other component of the formulation.

Design outcomes

Primary

Measure	Time frame
PaO2/FiO2 ratio (favorable when it is >=200). Measurement time: Group A: 1h, 4h and 8h after each dose. Group B: 1h, 4h and 8h after hemodynamic stabilization until complete 3 days	—

Secondary

Measure	Time frame
Gasometric evaluation (PaO2, PaCO2, pH, DA-aO2). Measurement time: Group A: 1h, 4h and 8h after each dose. Group B: 1h, 4h and 8h after hemodynamic stabilization until complete 3 days Ventilatory evaluation (Ventilatoria mode, V/minute, inspiratory current Volume, Expiratory current volume, Respiratory rate, I/E Ratio, Pr Peak, PMVA, FiO2 (default), PEEP, static lung compliance). Measurement time: Group A: 1h, 4h and 8h after each dose. Group B: 1h, 4h and 8h after hemodynamic stabilization until complete 3 days Clinic evaluation (Presence or absence of cyanosis, type of cyanosis). Measurement time: Group A: 1h, 4h and 8h after each dose. Group B: 1h, 4h and 8h after hemodynamic stabilization until complete 3 days Radiographic evaluation (Improvement, Stability, Worsening). Measurement time: Day 1, 2, 3 and 5 Length of ICU stay. Measurement time: 40 days. Mechanical ventilation days. Measurement time: 28 days. Endotracheal intubation days. Measurement time: 28 days. Total hospital days. Measurement time: 28 days. Condition of the patient (Live, Death). Measurement time: 28 days. All cause mortality. Measurement time: 28 days. Adverse Events (name, intensity, duration, attitude, result, relationship and treatment). Measurement time: 28 days.	—

Measure

Time frame

Gasometric evaluation (PaO2, PaCO2, pH, DA-aO2). Measurement time: Group A: 1h, 4h and 8h after each dose. Group B: 1h, 4h and 8h after hemodynamic stabilization until complete 3 days Ventilatory evaluation (Ventilatoria mode, V/minute, inspiratory current Volume, Expiratory current volume, Respiratory rate, I/E Ratio, Pr Peak, PMVA, FiO2 (default), PEEP, static lung compliance). Measurement time: Group A: 1h, 4h and 8h after each dose. Group B: 1h, 4h and 8h after hemodynamic stabilization until complete 3 days Clinic evaluation (Presence or absence of cyanosis, type of cyanosis). Measurement time: Group A: 1h, 4h and 8h after each dose. Group B: 1h, 4h and 8h after hemodynamic stabilization until complete 3 days Radiographic evaluation (Improvement, Stability, Worsening). Measurement time: Day 1, 2, 3 and 5 Length of ICU stay. Measurement time: 40 days. Mechanical ventilation days. Measurement time: 28 days. Endotracheal intubation days. Measurement time: 28 days. Total hospital days. Measurement time: 28 days. Condition of the patient (Live, Death). Measurement time: 28 days. All cause mortality. Measurement time: 28 days. Adverse Events (name, intensity, duration, attitude, result, relationship and treatment). Measurement time: 28 days.

—

Countries

Cuba

Contacts

Public ContactYinet Barrese Pérez

National Coordinating Center for Clinical Trials (CENCEC)

yinet@cencec.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026