Clinical trial NCT02562105: Prognosis of Hematological Cancer Patient Underwent Mechanical Ventillation
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematological Malignancy
Acute Respiratory Failure
Mechanical Ventilation
Keywords: Intensive care unit
Hematological malignancy
Acute respiratory failure
Prognosis
Mechanical ventilation
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hematological cancer patients admitted to ICU of oncology center, Mansoura University

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Survival
timeFrame: through study completion, an average of 30 days after admission to intensive care unit
Secondary outcomes:
measure: Sequential Organ Failure Assessment score
timeFrame: up to 24 hours after admission to the intensive care unit
measure: Simplified Acute Physiology Score II
timeFrame: up to 24 hours after admission to the intensive care unit
measure: Mode of mechanical ventilation
timeFrame: up to 24 hours after admission to the intensive care unit
measure: lowest Pa02/FiO2
timeFrame: up to 24 hours after admission to the intensive care unit
measure: Reason for need of ventilatory support
timeFrame: up to 24 hours after admission to the intensive care unit
Other outcomes:
measure: Associated comorbidities
timeFrame: up to 24 hours after admission to the intensive care unit
measure: Cancer status
timeFrame: up to 24 hours after admission to the intensive care unit
Locations:
city: Mansoura
country: Egypt
facility: Mansoura Cancer Therapy Center
state: Dakahlia
Study officials:
affiliation: Mansoura University, College of Medicine
name: Dr.Enas A Abd El motlb, MD
role: PRINCIPAL_INVESTIGATOR
References: