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

Long Term Outcomes in Critically Ill Haematological Patients. The Use of Intensive Care in Critically Ill Cancer Haematological Patients

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.

Study Overview

• Status: Completed
• Conditions: Hematological Malignancies

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.

• Study Type: Observational
• Enrollment (Actual): 1011

Contacts and Locations

Study Locations

• France
  • Paris, France, 75475
    • Hôpital Saint-Louis, AP-HP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with heamatological malignancy adressed to ICU

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients who have already participated to TRIAL-OH

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival status at one year	survival status (alive or death) at one year	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of life of patients and their relatives		day 90 and 1 year
ICU mortality	survival status at ICU discharge	1 week (estimated mean time until ICU discharge)
Survival status		day 90
Hospital mortality	survival status at hospital discharge	3 weeks (estimated mean time until Hospital discharge)

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Elie Azoulay, MD, PhD, Saint-Louis Hospital, Paris, France

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: June 18, 2010
• First Submitted That Met QC Criteria: July 28, 2010
• First Posted (Estimate): July 29, 2010

Study Record Updates

• Last Update Posted (Estimate): April 18, 2016
• Last Update Submitted That Met QC Criteria: April 15, 2016
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Lymphoma; Septic shock; Leukemia; Dialysis; Mechanical ventilation; Neutropenia; Acute respiratory failure; Bone-Marrow Transplant; Post ICU burden; ICU triage
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Hematologic Diseases; Hematologic Neoplasms; Critical Illness
• Other Study ID Numbers: AOM 08235