Prognosis of Hematological Cancer Patient Underwent Mechanical Ventillation

• Sponsor: Mansoura University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02562105
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Duration (Months): 8
• Patients Per Site Per Month: 6.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematological Malignancy; Acute Respiratory Failure; Mechanical Ventilation	Procedure: Mechanical ventilation

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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 Start Date: Jan 1, 2015
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Mechanical ventilation requiring mechanical ventilation at admission to ICU for one day or more during the study period	Procedure: Mechanical ventilation; requiring mechanical ventilation at admission to ICU for one day or more during the study period

Outcome Measures

Primary Outcome Measures

1. Survival [through study completion, an average of 30 days after admission to intensive care unit]

   Continuing to live

Secondary Outcome Measures

1. Sequential Organ Failure Assessment score [up to 24 hours after admission to the intensive care unit]

   Sequential Organ Failure Assessment (SOFA) Score

2. Simplified Acute Physiology Score II [up to 24 hours after admission to the intensive care unit]

   Simplified Acute Physiology Score (SAPS II)

3. Mode of mechanical ventilation [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 [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 [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 Outcome Measures

1. Associated comorbidities [up to 24 hours after admission to the intensive care unit]

   Like as sepsis, acute respiratory distress syndorme, or leukopenia

2. Cancer status [up to 24 hours after admission to the intensive care unit]

   Early or advanced stage

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura Cancer Therapy Center	Mansoura	Dakahlia	Egypt	050

Sponsors and Collaborators

• Mansoura University

Investigators

• Principal Investigator: Dr.Enas A Abd El motlb, MD, Mansoura University, College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Enas Aly Abd El motlb, Assistant professor, Mansoura University
• ClinicalTrials.gov Identifier: NCT02562105
• Other Study ID Numbers: 15.05.42
• First Posted: Sep 29, 2015
• Last Update Posted: Sep 29, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by Enas Aly Abd El motlb, Assistant professor, Mansoura University: Intensive care unit; Hematological malignancy; Acute respiratory failure; Prognosis; Mechanical ventilation
• Additional relevant MeSH terms: Neoplasms; Hematologic Neoplasms; Respiratory Insufficiency

Study Results

No Results Posted as of Sep 29, 2015