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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01172132
Other study ID # AOM 08235
Secondary ID
Status Completed
Phase N/A
First received June 18, 2010
Last updated April 15, 2016
Start date November 2009
Est. completion date November 2011

Study information

Verified date November 2011
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1011
Est. completion date November 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Hematological malignancies

- hospitalization in ICU

- age >= 18 years

Exclusion Criteria:

- Patients who have already participated to TRIAL-OH

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
France Hôpital Saint-Louis, AP-HP Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

Lemiale V, Resche-Rigon M, Mokart D, Pène 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 i — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Survival status at one year survival status (alive or death) at one year 1 year No
Secondary Health related quality of life of patients and their relatives day 90 and 1 year No
Secondary ICU mortality survival status at ICU discharge 1 week (estimated mean time until ICU discharge) No
Secondary Survival status day 90 No
Secondary Hospital mortality survival status at hospital discharge 3 weeks (estimated mean time until Hospital discharge) No
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