Réa-MiniMax: Severe Acute Respiratory Failure in Hematology and Cancer Patients Without Bronchoalveolar Lavage

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00248443
First received: November 3, 2005
Last updated: February 17, 2011
Last verified: March 2007
  Purpose

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.


Condition Intervention Phase
Lymphoma
Cancer
Acute Respiratory Failure
Leukemia
Procedure: Fiberoptic bronchoscopy and bronchoalveolar lavage
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Severe Acute Respiratory Failure in Hematology and Cancer Patients Without Bronchoalveolar Lavage. A Multicentric Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Reduction in intubation rate [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mortality at 28 days [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Hospital mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Duration of mechanical ventilation (invasive or non invasive) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Psychological aftereffects [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 206
Study Start Date: August 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a malignant haemopathy or a cancer
  • Patients with severe acute respiratory failure requiring admission to an ICU
  • No argument for a congestive cardiac insufficiency (heart failure)
  • Patients who provided their informed consent

Exclusion Criteria:

  • Age less than 18
  • Patient who refuses to undergo fiberoptic bronchoscopy
  • Therapeutic limitation
  • Patients intubated at ICU admission
  • Etiological diagnosis of the acute respiratory failure known
  • Lack of available bronchoscopy
  • AIDS
  • Post-operative direct admission
  • Inclusion in another research protocol in the ICU (HURRIET law)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00248443

Locations
France
Service de Réanimation Médicale de l'Hôpital Saint-Louis
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Elie Azoulay, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Saliha DJANE, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00248443     History of Changes
Other Study ID Numbers: P040424
Study First Received: November 3, 2005
Last Updated: February 17, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Haematology and cancer patients
Acute respiratory failure
Bronchoalveolar lavage
Non invasive diagnostic tools
Mechanical ventilation
Intensive Care

Additional relevant MeSH terms:
Leukemia
Lymphoma
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on July 29, 2014