The Use of Intensive Care in Critically Ill Cancer Haematological Patients: "TRIAL-OH"

NCT01172132 | Completed

• 1 other identifier: AOM 08235
• Study Type: observational
• Target: 1,011
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine:

• Condition of intensive care unit (ICU) admission in patients with haematological malignancies.
• ICU hospital and up to one year mortality.
• Assessment of post ICU burden and health related quality at 90-d and 1 year.

Conditions

Hematological Malignancies

Keywords

Leukemia; Lymphoma; Bone-Marrow Transplant; Neutropenia; Acute respiratory failure; Mechanical ventilation; Post ICU burden; ICU triage; Dialysis; Septic shock

Outcome Measures

Primary Outcomes (1)

• Survival status at one year

  survival status (alive or death) at one year

  1 year

Secondary Outcomes (4)

• Health related quality of life of patients and their relatives

  day 90 and 1 year

• ICU mortality

  1 week (estimated mean time until ICU discharge)

• Survival status

  day 90

• Hospital mortality

  3 weeks (estimated mean time until Hospital discharge)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with heamatological malignancy adressed to ICU

You may qualify if:

• Hematological malignancies
• hospitalization in ICU
• age \>= 18 years

You may not qualify if:

• Patients who have already participated to TRIAL-OH

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Saint-Louis, AP-HP

Paris, 75475, France

Location

Related Publications (4)

• Camous L, Lemiale V, Canet E, Max A, Schnell D, Le Goff J, Rabbat A, Schlemmer B, Azoulay E. Clinical features of H1N1 2009 infection in critically ill immunocompromised patients. Crit Care. 2010;14(2):139. doi: 10.1186/cc8927. Epub 2010 Apr 14.

  PMID: 20392286 BACKGROUND

• Lemiale V, Resche-Rigon M, Mokart D, Pene F, Rabbat A, Kouatchet A, Vincent F, Bruneel F, Nyunga M, Lebert C, Perez P, Meert AP, Benoit D, Chevret S, Azoulay E. Acute respiratory failure in patients with hematological malignancies: outcomes according to initial ventilation strategy. A groupe de recherche respiratoire en reanimation onco-hematologique (Grrr-OH) study. Ann Intensive Care. 2015 Dec;5(1):28. doi: 10.1186/s13613-015-0070-z. Epub 2015 Sep 30.

  PMID: 26429355 RESULT

• Zafrani L, Resche-Rigon M, De Freitas Caires N, Gaudet A, Mathieu D, Parmentier-Decrucq E, Lemiale V, Mokart D, Pene F, Kouatchet A, Mayaux J, Vincent F, N'yunga M, Bruneel F, Rabbat A, Lebert C, Perez P, Meert AP, Benoit D, Darmon M, Azoulay E. Endothelial Cell-Specific Molecule-1 in Critically Ill Patients With Hematologic Malignancy. Crit Care Med. 2018 Mar;46(3):e250-e257. doi: 10.1097/CCM.0000000000002934.

  PMID: 29474336 DERIVED

• Contejean A, Lemiale V, Resche-Rigon M, Mokart D, Pene F, Kouatchet A, Mayaux J, Vincent F, Nyunga M, Bruneel F, Rabbat A, Perez P, Meert AP, Benoit D, Hamidfar R, Darmon M, Jourdain M, Renault A, Schlemmer B, Azoulay E. Increased mortality in hematological malignancy patients with acute respiratory failure from undetermined etiology: a Groupe de Recherche en Reanimation Respiratoire en Onco-Hematologique (Grrr-OH) study. Ann Intensive Care. 2016 Dec;6(1):102. doi: 10.1186/s13613-016-0202-0. Epub 2016 Oct 25.

  PMID: 27783381 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms; Leukemia; Lymphoma; Neutropenia; Shock, Septic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Agranulocytosis; Leukopenia; Cytopenia; Leukocyte Disorders; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Elie Azoulay, MD, PhD

  Saint-Louis Hospital, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2010
• First Posted: July 29, 2010
• Study Start: November 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: November 1, 2011
• Last Updated: April 18, 2016

Record last verified: 2011-11

Locations

FR (1)