Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248443
Status:
COMPLETED
Last Update Posted:
2011-02-18
First Post:
2005-11-03
Brief Title:
Réa-MiniMax Severe Acute Respiratory Failure in Hematology and Cancer Patients Without Bronchoalveolar Lavage
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Severe Acute Respiratory Failure in Hematology and Cancer Patients Without Bronchoalveolar Lavage A Multicentric Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The MiniMax study is a multicenter randomized controlled study aimed at demonstrating that a combination of non-invasive diagnostic tools are as effective as fiberoptic bronchoscopy and bronchoalveolar lavage FO-BAL in performing the etiological diagnosis of acute respiratory failure in cancer patients
Detailed Description:
Acute respiratory failure is a dreadful complication in cancer patients Indeed about 20 of the patients will present with pulmonary infiltrates but Intensive Care Unit ICU admission and mechanical ventilation will be needed in half of them resulting in mortality for most of the patients Managing cancer patients with respiratory failure implicates three mandatory tasks 1 early antibiotics administration covering suspected pathogens 2 search for the actual aetiology and 3 adequate supportive care with access to invasive or non invasive respiratory support Performing the etiological diagnosis is crucial Fiberoptic bronchoscopy and bronchoalveolar lavage FO-BAL remains the cornerstone of the management of pulmonary infiltrates in cancer patients However non-invasive diagnostic tools have been validated in the recent years Diagnostic and therapeutic impacts of FO-BAL are only of 30 to 60 and 15 to 60 respectively In neutropenic patients and recipients of bone marrow or stem cell transplantation this impact is significantly altered Moreover reports have highlighted significant rates of complications such as haemorrhage 5 respiratory deterioration 11 to 40 possibly heading to intubation and subsequent death Therefore balancing advantages to risks of FO-BAL is in order The MiniMax study is a multicenter randomized controlled study aimed at demonstrating that a combination of non-invasive diagnostic tools are as effective as FO-BAL in performing the etiological diagnosis of acute respiratory failure in cancer patients In addition these non-invasive tests might not lead to deterioration of the respiratory status and corresponding requirement to intubation and mechanical ventilation The group of investigators is used to manage cancer patients with pulmonary involvement In the 21 centres patients will be randomized to be managed either with FO-BAL or with only non-invasive tools In each case patients will be managed with the best supportive care including adequate antibiotics respiratory support and all needed life sustaining therapies Our hypothesis is to reduce intubation rate using a non-invasive approach without FO-LBA Surrogate markers will be hospital mortality and the number of diagnostic procedures in each group of patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None