Severe Pandemic H1N1 Infection in ICU: Comparative Resource Utilization

Novel H1N1 Influenzal Acute Respiratory Infection Clinical Trial

Official title:

Severe Pandemic H1N1 Infection in ICU: Comparative Resource Utilization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01485237
• Other study ID #: pandemic001
• Secondary ID: H2009:175
• Status: Completed
• Phase: N/A
• First received: December 1, 2011
• Last updated: December 1, 2015
• Start date: October 2009
• Est. completion date: December 2012

Study information

• Verified date: November 2015
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Infection
• Novel H1N1 Influenzal Acute Respiratory Infection
• Respiratory Tract Infections

Intervention

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.

Locations

Country	Name	City	State
Canada	Health Sciences Centre, Winnipeg	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	GlaxoSmithKline

Country where clinical trial is conducted

Canada,