Novel H1N1 Influenzal Acute Respiratory InfectionNCT01485237
Severe Pandemic H1N1 Infection in ICU: Comparative Resource Utilization
An observational study of Novel H1N1 Influenzal Acute Respiratory Infection, run by University of Manitoba at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Novel H1N1 Influenzal Acute Respiratory Infection
- What is being tested?
- We will compare the resources used by both groups
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2009to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- > 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
Who cannot join
- 1. Age less than 18 years
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- We will compare the resources used by both groups
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
We will compare the resources used by both groupsOther
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 | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: We will compare the resources used by both groups |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study startOct 2009
- Primary completionDec 2010
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Novel H1N1 Influenzal Acute Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Dr. Anand Kumar, University of Manitoba
- Investigators
- Anand Kumar, MD, Principal investigator, Health Sciences Centre, Winnipeg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485237
- Sponsor's protocol ID
- pandemic001
- Other IDs
- H2009:175
- Status last verified
- Nov 2015
- First submitted
- 1 Dec 2011
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Pandemic H1N1 Infection in ICU: Comparative Resource Utilization
- ClinicalTrials.gov ID
- NCT01485237
- Acronym / sponsor ID
- pandemic001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Oct 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 5 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Severe H1N1 pneumonia in adult patients | – | Other: We will compare the resources used by both groupsSevere adult H1N1 pneumonia patients undergoing antiviral and oxygen therapy, mechanical ventilation and support with pulmonary rescue therapies ( nitric oxide, ECMO, HFO)in Winnipeg |
| Severe pneumonia in adults not H1N1 | – | Other: We will compare the resources used by both groupsPatients admitted to the hospital and/or ICU with viral pneumonia, bacterial pneumonia, septic shock, ARDS in Winnipeg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- > 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
Key exclusion criteria (1 listed)
- 1. Age less than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| We will compare the resources used by both groupsThe 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. | Other | Severe H1N1 pneumonia in adult patients, Severe pneumonia in adults not H1N1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anand Kumar, MD principal investigator
Health Sciences Centre, Winnipeg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Novel H1N1 Influenzal Acute Respiratory Infection, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.