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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02562105
Other study ID # 15.05.42
Secondary ID
Status Completed
Phase N/A
First received September 23, 2015
Last updated September 27, 2015
Start date January 2015
Est. completion date September 2015

Study information

Verified date September 2015
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority Egypt: Ministry of Higher Education
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date September 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Mansoura Cancer Therapy Center Mansoura Dakahlia

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Other Associated comorbidities Like as sepsis, acute respiratory distress syndorme, or leukopenia up to 24 hours after admission to the intensive care unit Yes
Other Cancer status Early or advanced stage up to 24 hours after admission to the intensive care unit Yes
Primary Survival Continuing to live through study completion, an average of 30 days after admission to intensive care unit Yes
Secondary Sequential Organ Failure Assessment score Sequential Organ Failure Assessment (SOFA) Score up to 24 hours after admission to the intensive care unit Yes
Secondary Simplified Acute Physiology Score II Simplified Acute Physiology Score (SAPS II) up to 24 hours after admission to the intensive care unit Yes
Secondary Mode of mechanical ventilation synchronised intermittent, pressure-controlled, volume-controlled, pressure support, continuous positive airway pressure, volume guarantee, adjusted pressure release ventilation, or adaptive proportional assist ventilation up to 24 hours after admission to the intensive care unit No
Secondary lowest Pa02/FiO2 PaO2 "arterial oxygen tension"/FiO2 "inspired fraction of oxygen" ratio up to 24 hours after admission to the intensive care unit Yes
Secondary Reason for need of ventilatory support Advanced malignancy, respiratory muscle weakness, respiratory failure, lung metastasis, coma, sepsis, multi-organs failure up to 24 hours after admission to the intensive care unit No
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