SURFACEN in ARDS Adults. Phase II

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

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

Secondary indentifying numbers:

SU-01-2005

Issuing authority of the secondary identifying numbers:

National Centre of Animal and Plants Health(CENSA)

Source(s) of monetary or material support:

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

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

07/11/2005

Reference number:

05.026.05.B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Angela Olga Hidalgo Sanchez, MD. 2nd Degree Specialist in Intensive Care and emergency medicine. 1st degree specialist in internal medicine

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, Hospital "Hermanos Ameijeiras", Nora Lin Alonso, MD. 2nd Degree Specialist in Intensive Care. Havana Hospital "Carlos J. Finlay", Tania Luejes Garcia, MD. 2nd Degree Specialist in Intensive Care and Emergency Medicine. Havana Hospital "Salvador Allende", Alejandro Vazquez Drake, MD. 1st degree Specialist in Anesthesiology and Resuscitation. Havana Hospital "Luis Diaz Soto", Javier Joanes Fiol, MD. 1st Degree Specialist in Anesthesiology and Reanimation. 2nd Degree Specialist in in Intensive Care and Emergency Medicine. Havana Hospital "Miguel Enriquez", Jorge Perez Soneira, MD. 1st degree specialist in Internal Medicine. Villa Clara, Hospital "Arnaldo Milian", Mauro Lopez Ortega, MD. 1st degree specialist in Anesthesiology and Resuscitation, 2nd Degree Specialist in Intensive Care and Emergency Medicine. Las Tunas, Hospital "Ernesto Guevara", Osmany Rojas, MD. 1st Degree Specialist in Internal Medicine. 1st Degree Specialist in Intensive Medicine. Holguin, Hospital "Vladimir I. Lenin", Carlos Medina Merino, MD. 1st Degree Specialist in Internal Medicine. 1st Degree Specialist in Intensive Medicine. Sancti Spiritus, Hospital "Camilo Cienfuegos", Rodolfo L. Rodriguez Gomez, MD. 1st Degree Specialist in Internal Medicine. Camagüey Hospital "Manuel Ascunce", Olga Caveda Estela, MD. 1st degree specialist in Anesthesiology. And Reanimation. 2nd Degree Specialist in Intensive Care and Emergency Medicine.

Research ethics committees:

Ethics and Review Centralized Committee, approved on 31/05/2005

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

21/03/2006

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

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

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

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

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

75 years

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

2

Target sample size:

72

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Yinet

Last Name:

Barrese Pérez

Affiliation:

National Coordinating Center for Clinical Trials (CENCEC)

Postal Address:

Calle 200 e/ 19 y 21. Atabey Playa.

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

(537)-271-7345 (537)-271-7397

Email :

yinet@cencec.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Angela

Middle Name:

Olga

Last Name:

Hidalgo Sánchez

Affiliation:

Hospital “Calixto Garcia”

Postal Address:

Universidad esq. a J Vedado, Plaza de la Revolucion

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

(537)-8552197 (537)-8552171 (537)-8552175

Email :

iaso@infomed.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000126

Date of Registration in Primary Registry:

2012-04-11

Record Verification Date:

2012-04-09 20:00

Link to the spanish version:

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SURFACEN in ARDS Adults. Phase II

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