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NCT Number: NCT02562105

Prognosis of Hematological Cancer Patient Underwent Mechanical Ventillation

This observational cohort aimed to re-evaluate the outcome of hematologic cancer patients admitted to the intensive care unit of Mansoura oncology center through a cohort study as regards their need for mechanical ventilation during two years.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mansoura Cancer Therapy Center

Al Mansurah, Dakahlia Governorate, 050, Egypt

About this study

It has been believed for many years that the scene of cancer patients requiring mechanical ventilation is frustrating. The needed life support measures drain much of health resources and add a significant burden on the patient's family. Many factors have been responsible for the high mortality rates among hematologic cancer patients admitted to intensive care unit. Among of these factors, the invasive treatments that are frequently employed in today's intensive care unit. These procedures give chance for development of severe infection and multiple organ failure which are common events in immune-compromised patients (e.g. neutropenia) and in those exposed to chemotherapy. The most common form of organ failure in those patients is acute respiratory failure which is a major predictor of mortality in that population. The prognosis of such failure may vary depending on its causes and severity, co morbidity, associated acute organ failure and characters of the underlying malignancy. After the recent advances in the field of intensive care and shedding light on the benefits of the noninvasive ventilation in immune-compromised patients, the overall survival rate of cancer patients admitted to intensive care unit are improving.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Critical ill hematological cancer patient
  • Requiring mechanical ventilation

Exclusion criteria

  • Patients with acute coronary syndrome.
  • Patients with cancer remission more than 5 years.

Treatment and study plan

mechanical ventilation

Procedure

requiring mechanical ventilation at admission to ICU for one day or more during the study period

Primary outcomes

  1. Survival

    Time frame: through study completion, an average of 30 days after admission to intensive care unit

    Continuing to live

Secondary outcomes

  1. Sequential Organ Failure Assessment score

    Time frame: up to 24 hours after admission to the intensive care unit

    Sequential Organ Failure Assessment (SOFA) Score

  2. Simplified Acute Physiology Score II

    Time frame: up to 24 hours after admission to the intensive care unit

    Simplified Acute Physiology Score (SAPS II)

  3. Mode of mechanical ventilation

    Time frame: up to 24 hours after admission to the intensive care unit

    synchronised intermittent, pressure-controlled, volume-controlled, pressure support, continuous positive airway pressure, volume guarantee, adjusted pressure release ventilation, or adaptive proportional assist ventilation

  4. lowest Pa02/FiO2

    Time frame: up to 24 hours after admission to the intensive care unit

    PaO2 "arterial oxygen tension"/FiO2 "inspired fraction of oxygen" ratio

  5. Reason for need of ventilatory support

    Time frame: up to 24 hours after admission to the intensive care unit

    Advanced malignancy, respiratory muscle weakness, respiratory failure, lung metastasis, coma, sepsis, multi-organs failure

Other outcomes

  1. Associated comorbidities

    Time frame: up to 24 hours after admission to the intensive care unit

    Like as sepsis, acute respiratory distress syndorme, or leukopenia

  2. Cancer status

    Time frame: up to 24 hours after admission to the intensive care unit

    Early or advanced stage

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

In a Developing Country; What is the Fate of Hematologic Cancer Patients Requiring Mechanical Ventilation for More Than One Day? A Prospective Cohort Study

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 29, 2015
Registry last updated
Sep 29, 2015

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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