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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01172132
First Posted: July 29, 2010
Last Update Posted: April 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  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:


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

Primary Outcome Measures:
  • Survival status at one year [ Time Frame: 1 year ]
    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 ]
  • ICU mortality [ Time Frame: 1 week (estimated mean time until ICU discharge) ]
    survival status at ICU discharge

  • Survival status [ Time Frame: day 90 ]
  • Hospital mortality [ Time Frame: 3 weeks (estimated mean time until Hospital discharge) ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01172132     History of Changes
Other Study ID Numbers: AOM 08235
First Submitted: June 18, 2010
First Posted: July 29, 2010
Last Update Posted: April 18, 2016
Last Verified: November 2011

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:
Critical Illness
Disease Attributes
Pathologic Processes