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

Cancer Clinical Trial

Official title:

Severe Acute Respiratory Failure in Hematology and Cancer Patients Without Bronchoalveolar Lavage. A Multicentric Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00248443
• Other study ID #: P040424
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2005
• Last updated: February 17, 2011
• Start date: August 2005
• Est. completion date: August 2008

Study information

• Verified date: March 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Cancer
• Leukemia
• Lymphoma
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Procedure:
• Fiberoptic bronchoscopy and bronchoalveolar lavage

Locations

Country	Name	City	State
France	Service de Réanimation Médicale de l'Hôpital Saint-Louis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (3)

Dunagan DP, Baker AM, Hurd DD, Haponik EF. Bronchoscopic evaluation of pulmonary infiltrates following bone marrow transplantation. Chest. 1997 Jan;111(1):135-41. — View Citation

Murray PV, O'Brien ME, Padhani AR, Powles R, Cunningham D, Jeanes A, Ashley S. Use of first line bronchoalveolar lavage in the immunosuppressed oncology patient. Bone Marrow Transplant. 2001 May;27(9):967-71. — View Citation

White P, Bonacum JT, Miller CB. Utility of fiberoptic bronchoscopy in bone marrow transplant patients. Bone Marrow Transplant. 1997 Oct;20(8):681-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in intubation rate		28 days	Yes
Secondary	Mortality at 28 days		28 days	Yes
Secondary	Hospital mortality		28 days	Yes
Secondary	Duration of mechanical ventilation (invasive or non invasive)		28 days	Yes
Secondary	Psychological aftereffects		28 days	Yes