Clinical trial NCT01172132: The Use of Intensive Care in Critically Ill Cancer Haematological Patients: "TRIAL-OH"
Official title: Long Term Outcomes in Critically Ill Haematological Patients. The Use of Intensive Care in Critically Ill Cancer Haematological Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematological Malignancies
Keywords: Leukemia
Lymphoma
Bone-Marrow Transplant
Neutropenia
Acute respiratory failure
Mechanical ventilation
Post ICU burden
ICU triage
Dialysis
Septic shock
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-07-29
Enrollment: 1011
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with heamatological malignancy adressed to ICU

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.

Detailed description: 1. To identify prognostic factors of short and medium term mortality, by underlining the respective weights of organ dysfunction and characteristics of underlined malignancy
2. Evaluate the health related quality of life of intensive care survivors(SF36)
3. Impact of intensive care on families burden (HADS, IES).
4. Assess clinicians' satisfaction ( intensivists, haematologists and intensive care nurses) in relation to medical decision-making.
5. Establish the relevance of antifungal treatments.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients who have already participated to TRIAL-OH

Primary outcomes:
measure: Survival status at one year
timeFrame: 1 year
Secondary outcomes:
measure: Health related quality of life of patients and their relatives
timeFrame: day 90 and 1 year
measure: ICU mortality
timeFrame: 1 week (estimated mean time until ICU discharge)
measure: Survival status
timeFrame: day 90
measure: Hospital mortality
timeFrame: 3 weeks (estimated mean time until Hospital discharge)
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Saint-Louis, AP-HP
Study officials:
affiliation: Saint-Louis Hospital, Paris, France
name: Elie Azoulay, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.