Severe Pandemic H1N1 Infection in ICU: Comparative Resource Utilization

This study is ongoing, but not recruiting participants.

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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 1, 2011

Last Updated Date

July 3, 2012

Start Date ^ICMJE

October 2009

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01485237 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Severe Pandemic H1N1 Infection in ICU: Comparative Resource Utilization

Official Title ^ICMJE

Severe Pandemic H1N1 Infection in ICU: Comparative Resource Utilization

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition ^ICMJE

Novel H1N1 Influenzal Acute Respiratory Infection

Intervention ^ICMJE

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.

Study Group/Cohort (s)

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

Intervention: Other: We will compare the resources used by both groups
Severe pneumonia in adults not H1N1
Patients admitted to the hospital and/or ICU with viral pneumonia, bacterial pneumonia, septic shock, ARDS in Winnipeg

Intervention: Other: We will compare the resources used by both groups

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

400

Estimated Completion Date

December 2012

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

> 18years,
Suspected or confirmed influenza (Appendix A)
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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01485237

Other Study ID Numbers ^ICMJE

pandemic001, H2009:175

Has Data Monitoring Committee

Responsible Party

Dr. Anand Kumar, University of Manitoba

Study Sponsor ^ICMJE

University of Manitoba

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Principal Investigator:

Anand Kumar, MD

Health Sciences Centre, Winnipeg

Information Provided By

University of Manitoba

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top