SURFACEN in ARDS Adults. Phase II

• Register: RPCEC
• Last refreshed on: 27 May 2013
• Main ID: RPCEC00000126
• Date of registration: 11/04/2012
• Primary sponsor: National Centre of Animal and Plants Health(CENSA)
• Public title: SURFACEN in ARDS Adults. Phase II
• Scientific title: Evaluation of the effect and safety of SURFACEN in the treatment of acute respiratory distress syndrome in adults
• Date of first enrolment: 21/03/2006
• Target sample size: 72
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000126-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Open. Placebo: Active Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Yinet Barrese Pérez
• Affiliation: National Coordinating Center for Clinical Trials (CENCEC)

• Name: Angela Hidalgo Sánchez
• Affiliation: Hospital “Calixto Garcia”

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

Age minimum: 18 years
Age maximum: 75 years
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Respiratory Distress Syndrome in adults

Intervention(s)

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 mechanical ventilation

Primary Outcome(s)

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 Outcome(s)

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.

Secondary ID(s)

SU-01-2005

Source(s) of Monetary Support

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

Secondary Sponsor(s)

Not applicable