NCT02562105

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2015

Completed
Last Updated

September 29, 2015

Status Verified

September 1, 2015

Enrollment Period

7 months

First QC Date

September 23, 2015

Last Update Submit

September 27, 2015

Conditions

Hematological MalignancyAcute Respiratory FailureMechanical Ventilation

Keywords

Intensive care unitHematological malignancyAcute respiratory failurePrognosisMechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Survival

    Continuing to live

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

Secondary Outcomes (5)

  • Sequential Organ Failure Assessment score

    up to 24 hours after admission to the intensive care unit

  • Simplified Acute Physiology Score II

    up to 24 hours after admission to the intensive care unit

  • Mode of mechanical ventilation

    up to 24 hours after admission to the intensive care unit

  • lowest Pa02/FiO2

    up to 24 hours after admission to the intensive care unit

  • Reason for need of ventilatory support

    up to 24 hours after admission to the intensive care unit

Other Outcomes (2)

  • Associated comorbidities

    up to 24 hours after admission to the intensive care unit

  • Cancer status

    up to 24 hours after admission to the intensive care unit

Study Arms (1)

Mechanical ventilation

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

Procedure: Mechanical ventilation

Interventions

Mechanical ventilationPROCEDURE

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

Mechanical ventilation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hematological cancer patients admitted to ICU of oncology center, Mansoura University

You may qualify if:

  • Critical ill hematological cancer patient
  • Requiring mechanical ventilation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura Cancer Therapy Center

Al Mansurah, Dakahlia Governorate, 050, Egypt

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Study Officials

  • Dr.Enas A Abd El motlb, MD

    Mansoura University, College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 23, 2015

First Posted

September 29, 2015

Study Start

January 1, 2015

Primary Completion

August 1, 2015

Study Completion

September 1, 2015

Last Updated

September 29, 2015

Record last verified: 2015-09

Locations

EG(1)