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

NCT ID: NCT01172132

Last Updated: 2016-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1011 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-11-30

Brief Summary

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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

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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.

Conditions

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Hematological Malignancies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients who have already participated to TRIAL-OH
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elie Azoulay, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Saint-Louis Hospital, Paris, France

Locations

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Hôpital Saint-Louis, AP-HP

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 20392286 (View on PubMed)

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.

Reference Type RESULT
PMID: 26429355 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29474336 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27783381 (View on PubMed)

Other Identifiers

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AOM 08235

Identifier Type: -

Identifier Source: org_study_id

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