Severe Pandemic H1N1 Infection in ICU: Comparative Resource Utilization

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University of Manitoba.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Dr. Anand Kumar, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01485237
First received: December 1, 2011
Last updated: July 3, 2012
Last verified: July 2012
  Purpose

The main purpose of this study is to review the resource utilization of severe adult H1N1 pneumonia undergoing antiviral and oxygen therapy, mechanical ventilation and support with pulmonary rescue therapies ( nitric oxide, ECMO, HFO) in critically ill patients in Winnipeg. Secondary objectives include, comparison of resource utilization to other similar disorders (viral pneumonia, bacterial pneumonia, septic shock, ARDS). The investigators will also look at the percentage of patients that required ICU care as compared to those who could be cared for on medical wards. The investigators will determine the resources used by both groups and compare. Finally the investigators will record the frequency of chronic comorbidities in hospitalized adult H1N1 patients.


Condition Intervention
Novel H1N1 Influenzal Acute Respiratory Infection
Other: We will compare the resources used by both groups

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Severe Pandemic H1N1 Infection in ICU: Comparative Resource Utilization

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Enrollment: 400
Study Start Date: October 2009
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Severe H1N1 pneumonia in adult patients
Severe adult H1N1 pneumonia patients undergoing antiviral and oxygen therapy, mechanical ventilation and support with pulmonary rescue therapies ( nitric oxide, ECMO, HFO)in Winnipeg
Other: We will compare the resources used by both groups
The main purpose of this study is to review the resource utilization. Secondary objectives include, comparison of resource utilization to other similar disorders (viral pneumonia, bacterial pneumonia, septic shock, ARDS). We will also look at the percentage of patients that required ICU care as compared to those who could be cared for on medical wards. We will determine the resources used by both groups and compare. Finally we will record the frequency of chronic comorbidities in hospitalized adult H1N1 patients.
Severe pneumonia in adults not H1N1
Patients admitted to the hospital and/or ICU with viral pneumonia, bacterial pneumonia, septic shock, ARDS in Winnipeg
Other: We will compare the resources used by both groups
The main purpose of this study is to review the resource utilization. Secondary objectives include, comparison of resource utilization to other similar disorders (viral pneumonia, bacterial pneumonia, septic shock, ARDS). We will also look at the percentage of patients that required ICU care as compared to those who could be cared for on medical wards. We will determine the resources used by both groups and compare. Finally we will record the frequency of chronic comorbidities in hospitalized adult H1N1 patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with severe adult H1N1 pneumonia undergoing antiviral and oxygen therapy, mechanical ventilation and support with pulmonary rescue therapies ( nitric oxide, ECMO, HFO) in critically ill patients in Winnipeg. Patients with other similar disorders (viral pneumonia, bacterial pneumonia, septic shock, ARDS)that may require some of the same treatments.

Criteria

Inclusion Criteria:

  1. > 18years,
  2. Suspected or confirmed influenza (Appendix A)
  3. Requirement for ICU admission due to respiratory distress or critical illness defined as one of:a) Inspired oxygen need of >50% for at least 4 hours (For FiO2 for non-intubated patients see Appendix B) b) mechanical ventilation c) Patient is receiving inotrope or vasopressor

Exclusion Criteria:

1. Age less than 18 years

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485237

Locations
Canada, Manitoba
Health Sciences Centre, Winnipeg
Winnipeg, Manitoba, Canada, R3A 1R9
Sponsors and Collaborators
University of Manitoba
GlaxoSmithKline
Investigators
Principal Investigator: Anand Kumar, MD Health Sciences Centre, Winnipeg
  More Information

No publications provided

Responsible Party: Dr. Anand Kumar, Intensivist, University of Manitoba
ClinicalTrials.gov Identifier: NCT01485237     History of Changes
Other Study ID Numbers: pandemic001, H2009:175
Study First Received: December 1, 2011
Last Updated: July 3, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Communicable Diseases
Infection
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 30, 2014