ALI/ARDS in Oncologic Pediatric Patients
This study is ongoing, but not recruiting participants.
Sponsor:
Grupo de Apoio ao Adolescente e a Crianca com Cancer
Information provided by (Responsible Party):
Rodrigo Genaro Arduini, Grupo de Apoio ao Adolescente e a Crianca com Cancer
ClinicalTrials.gov Identifier:
NCT01304654
First received: February 24, 2011
Last updated: March 13, 2013
Last verified: March 2013
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Purpose
Identify pediatric oncologic patients with ALI/ARDS at GRAACC/IOP's Pediatric Intensive Care Unit and evaluate the mechanical ventilation practice in these subjects for a 48mo period.
| Condition |
|---|
|
Acute Lung Injury Acute Respiratory Distress Syndrome Neoplasms |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Practice of Mechanical Ventilation in Pediatric Oncologic Patients Diagnosed With Acute Lung Injury / Acute Respiratory Distress Syndrome |
Resource links provided by NLM:
Further study details as provided by Grupo de Apoio ao Adolescente e a Crianca com Cancer:
Primary Outcome Measures:
- Identify pediatric oncologic patients with ALI/ARDS at GRAACC's PICU and evaluate how they are mechanically ventilated [ Time Frame: 2y ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Epidemiologic data about the selected patients [ Time Frame: 28 days ] [ Designated as safety issue: No ]Type and data about their mechanical ventilation, etiologic factors for ALI/ARDS, mortality rates, predictive factors about outcomes (death/ discharge), necessity and types of rescue therapies (surfactant, prone position, corticosteroids, etc.)
| Enrollment: | 29 |
| Study Start Date: | January 2011 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
ALI/ARDS oncologic patients
Consecutively admitted patients at GRAACC's PICU with malignancy diagnosis according to IDC-10, in a 24mo consecutive period, under mechanical ventilation for over 24h and with ALI/ARDS criteria, not younger than 29 days or older than 17 years 11 months
|
Detailed Description:
Evaluate adequate mechanical ventilation based on protective ventilation protocols for children available so far.
Evaluate and describe the subjects. Evaluate the necessity and outcome of rescue therapies (surfactant, prone position, corticosteroids, alveolar recruitment) Obtain data about ALI/ARDS' etiology, mortality rates and predictive factors related to the outcomes (PICU/ hospital discharge or death)
Eligibility| Ages Eligible for Study: | up to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Pediatric oncologic patients
Criteria
Inclusion Criteria:
- patients admitted at the intensive care unit with diagnosis of acute lung injury or acute respiratory distress syndrome and submitted to mechanical ventilation for over 24h
Exclusion Criteria:
- mechanical ventilation less than 24h
- absence of ALI/ARDS criteria
- no neoplasm diagnosis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01304654
Locations
| Brazil | |
| Grupo de Apoio ao Adolescente e à Criança com Câncer | |
| Sao Paulo, Brazil, 04023-062 | |
Sponsors and Collaborators
Grupo de Apoio ao Adolescente e a Crianca com Cancer
Investigators
| Principal Investigator: | Rodrigo G Arduini, MD | Grupo de Apoio ao Adolescente e a Crianca com Cancer |
More Information
No publications provided
| Responsible Party: | Rodrigo Genaro Arduini, MD, Grupo de Apoio ao Adolescente e a Crianca com Cancer |
| ClinicalTrials.gov Identifier: | NCT01304654 History of Changes |
| Other Study ID Numbers: | UTI/IOP 02/11, 0031/11 |
| Study First Received: | February 24, 2011 |
| Last Updated: | March 13, 2013 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by Grupo de Apoio ao Adolescente e a Crianca com Cancer:
|
acute lung injury respiratory distress syndrome neoplasms child |
Additional relevant MeSH terms:
|
Neoplasms Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Injury Lung Diseases |
Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Thoracic Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013