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Completed

NCT Number: NCT01172132

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

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.

Completed

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Key information

Conditions

Hematological Malignancies Agranulocytosis Cytopenia Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Infections Inflammation Leukemia Leukocyte Disorders Leukopenia Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neutropenia Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Saint-Louis, AP-HP

Paris, 75475, France

About this study

  • To identify prognostic factors of short and medium term mortality, by underlining the respective weights of organ dysfunction and characteristics of underlined malignancy
  • Evaluate the health related quality of life of intensive care survivors(SF36)
  • Impact of intensive care on families burden (HADS, IES).
  • Assess clinicians' satisfaction ( intensivists, haematologists and intensive care nurses) in relation to medical decision-making.
  • Establish the relevance of antifungal treatments.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients who have already participated to TRIAL-OH

Treatment and study plan

Primary outcomes

  1. Survival status at one year

    Time frame: 1 year

    survival status (alive or death) at one year

Secondary outcomes

  1. Health related quality of life of patients and their relatives

    Time frame: day 90 and 1 year

  2. ICU mortality

    Time frame: 1 week (estimated mean time until ICU discharge)

    survival status at ICU discharge

  3. Survival status

    Time frame: day 90

  4. Hospital mortality

    Time frame: 3 weeks (estimated mean time until Hospital discharge)

    survival status at hospital discharge

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 29, 2010
Registry last updated
Apr 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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