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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01172132
First received: June 18, 2010
Last updated: November 19, 2012
Last verified: November 2011
History of Changes
  Purpose

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.

Condition
Hematological Malignancies

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Outcomes in Critically Ill Haematological Patients. The Use of Intensive Care in Critically Ill Cancer Haematological Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Survival status at one year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    survival status (alive or death) at one year


Secondary Outcome Measures:
  • Health related quality of life of patients and their relatives [ Time Frame: day 90 and 1 year ] [ Designated as safety issue: No ]
  • ICU mortality [ Time Frame: 1 week (estimated mean time until ICU discharge) ] [ Designated as safety issue: No ]
    survival status at ICU discharge

  • Survival status [ Time Frame: day 90 ] [ Designated as safety issue: No ]
  • Hospital mortality [ Time Frame: 3 weeks (estimated mean time until Hospital discharge) ] [ Designated as safety issue: No ]
    survival status at hospital discharge


Enrollment: 1011
Study Start Date: November 2009
Study Completion Date: November 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with heamatological malignancy adressed to ICU

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who have already participated to TRIAL-OH
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172132

Locations
France
Hôpital Saint-Louis, AP-HP
Paris, France, 75475
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Elie Azoulay, MD, PhD Saint-Louis Hospital, Paris, France
  More Information

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01172132     History of Changes
Other Study ID Numbers: AOM 08235
Study First Received: June 18, 2010
Last Updated: November 19, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Leukemia
Lymphoma
Bone-Marrow Transplant
Neutropenia
Acute respiratory failure
 Mechanical ventilation
Post ICU burden
ICU triage
Dialysis
Septic shock

Additional relevant MeSH terms:
Neoplasms
Critical Illness
Hematologic Neoplasms
Disease Attributes
 Pathologic Processes
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013