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

Hematological Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01172132
• Other study ID #: AOM 08235
• 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

• Critical Illness
• Hematological Malignancies

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