Characteristics and Outcomes of Intensive Care Unit Patie... | NCT01011582

Studies
Characteristics and Outcomes of Intensive Care Unit Patients Admitted With Novel H1N1 Influenza or Seasonal Influenza

NCT01011582

Sponsor

Virginia Commonwealth University

Status

Completed

Last Update Posted

Jan 8, 2013Estimated

Enrollment

4Actual

Phase

Not provided

Conditions

H1N1 Influenza
Seasonal Influenza

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Nov 9, 2009

First Submission Date that Met QC Criteria

Nov 10, 2009

First Posted Date

Nov 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2013

Last Update Posted Date

Jan 8, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this research study is to collect information on problems that patients with the novel H1N1 influenza and/or the seasonal influenza experience. Novel H1N1 flu is also called the swine flu. Seasonal influenza is also called the regular flu. The purpose of this study is to collect information from patients who are infected with either the novel H1N1 or the seasonal flu and to determine what makes patients critically ill with these infections. The goal is to develop a registry that will aid investigators in determining specific markers that lead to development of severe illness in these infections.

Detailed Description

Patients admitted to the medical intensive care unit with either novel H1N1 infection or seasonal influenza infection may be eligible for participation.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

4Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome is to contrast patients infected with novel H1N1 influenza to those infected with seasonal influenza.		Patients will be evaluated until May 31, 2010

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients admitted to the medical intensive care unit with a diagnosis of novel H1N1 influenza infection or with a diagnosis of seasonal influenza infection.

Exclusion Criteria:

Prisoners
Refusal of study participation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients admitted to the medical intensive care unit at Virginia Commonwealth University Medical Center, Richmond, Virginia.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marjolein de Wit, M.D., M.S.	Virginia Commonwealth University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Commonwealth University Medical Center (formerly known as Medical College of Virginia)		Richmond	Virginia	23298	United States

Condition Browse Module

MeSH Terms

ID	Term
D009976	Orthomyxoviridae Infections

Ancestor Terms

ID	Term
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided