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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01046331
Other study ID # 688
Secondary ID N01HR56179HSN268
Status Completed
Phase N/A
First received January 8, 2010
Last updated April 13, 2016
Start date October 2009
Est. completion date October 2010

Study information

Verified date November 2010
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

The demographic characteristics, clinical features, course, and outcomes of severe H1N1 influenza infection requiring intensive care have not been defined rigorously and systematically. While the majority of patients in early reports of critically ill novel influenza A (H1N1) have respiratory involvement, up to 10-20% may present with non-respiratory organ failures, such as shock, seizures, or acute renal failure. The burden of disease and resource utilization of these patients remains largely unknown. The purpose of this surveillance registry is to characterize the demographics, clinical features, outcomes, and resource utilization of patients with H1N1 influenza infection who require intensive care.


Recruitment information / eligibility

Status Completed
Enrollment 894
Est. completion date October 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Admission to an intensive care unit at a participating site with confirmed or suspected Novel H1N1 Influenza infection

Exclusion Criteria:

- Influenza-like illness due to non-influenza disease and negative testing for influenza

Study Design

Observational Model: Cohort


Related Conditions & MeSH terms


Locations

Country Name City State
United States Alaska Native Medical Center Anchorage Alaska
United States The Children's Hospital at Providence Anchorage Alaska
United States Children's Healthcare of Atlanta at Egleston Atlanta Georgia
United States Denver's Children Hospital Aurora Colorado
United States Dell Children's Medical Center of Central Texas Austin Texas
United States Johns Hopkins Bayview Medical Center Baltimore Maryland
United States Johns Hopkins Children's Center Baltimore Maryland
United States Johns Hopkins Hospital Baltimore Maryland
United States Union Memorial Hospital Baltimore Maryland
United States University of Maryland Shock Trauma Center Baltimore Maryland
United States Earl K. Long Medical Center Baton Rouge Louisiana
United States Our Lady of the Lake Regional Medical Center Baton Rouge Louisiana
United States Boston Medical Center Boston Massachusetts
United States Children's Hospital Boston Boston Massachusetts
United States Children's Hospital of Montefiore Bronx New York
United States University of North Carolina Chapel Hill North Carolina
United States University of Virginia Children's Medical Center Charlottesville Virginia
United States University of Virginia Medical Center Charlottesville Virginia
United States Children's Memorial Hospital Chicago Illinois
United States Cleveland Clinic Foundation Cleveland Ohio
United States MetroHealth Medical Center Cleveland Ohio
United States University Hospitals of Cleveland Cleveland Ohio
United States Nationwide Children' Hospital Columbus Ohio
United States University of Texas Southwestern Children's Medical Center Dallas Texas
United States Centura St. Anthony Central Hospital Denver Colorado
United States Denver Health Medical Center Denver Colorado
United States Rose Medical Center Denver Colorado
United States University of Colorado Health Sciences Center Denver Colorado
United States Duke University Children's Hospital Durham North Carolina
United States Duke University Medical Center Durham North Carolina
United States Durham Regional Medical Center Durham North Carolina
United States Providence Hospital Everett Washington
United States University of San Francisco-Fresno Medical Center Fresno California
United States Helen DeVos Children's Hospital Grand Rapids Michigan
United States Moses Cone Health System Greensboro North Carolina
United States Wesley Long Community Hospital Greensboro North Carolina
United States Connecticut Children's Medical Center Hartford Connecticut
United States Penn State Children's Hospital Hershey Pennsylvania
United States Kapi'olani Center for Women and Children Honolulu Hawaii
United States Baylor College of Medicine Houston Texas
United States Texas Children's Hospital Houston Texas
United States Mayo Clinic at Jacksonville Jacksonville Florida
United States Darthmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Arkansas Children's Hiospital Little Rock Arkansas
United States Children's Hospital Los Angeles Los Angeles California
United States Kosair Children's Hospital Louisville Kentucky
United States Holt'z Children's Hospital Miami Florida
United States Miami Children's Hospital Miami Florida
United States Children's Hospital of Wisconsin Milwaukee Wisconsin
United States Children's Hospital and Clinics of Minnesota Minneapolis Minnesota
United States University of Minnesota Children's Hospital Minneapolis Minnesota
United States Intermountain Medical Center Murray Utah
United States Monroe Carell Children's Hospital at Vanderbilt Nashville Tennessee
United States Vanderbilt University Medical Center Nashville Tennessee
United States Yale-New Haven Children's Hospital New Haven Connecticut
United States Medical Center of Louisiana New Orleans Louisiana
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Tulane University Health Sciences Center New Orleans Louisiana
United States Children's Hospital and Research Center Oakland Oakland California
United States McKay-Dee Hospital Ogden Utah
United States Children's Hospital of Nebraska Omaha Nebraska
United States Children's Hospital of Orange County Orange California
United States The Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Phoenix Children's Hospital Phoenix Arizona
United States Doernbecher Children's Hospital Portland Oregon
United States Utah Valley Regional Medical Center Provo Utah
United States University of Rochester Medical Center Rocherster New York
United States Rochester Methodist Hospital Rochester Minnesota
United States St. Mary's Hospital, Mayo Clinic Rochester Minnesota
United States University of California, Davis Medical Center Sacramento California
United States LDS Hospital Salt Lake City Utah
United States Primary Children's Medical Center Salt Lake City Utah
United States UCSF Children's Medical Center San Francisco California
United States UCSF-Moffitt Hospital San Francisco California
United States UCSF-San Francisco General Hospital San Francisco California
United States University of California, San Francisco (UCSF)-Moffitt Hospital San Francisco California
United States Harborview Medical Center Seattle Washington
United States Seattle Children's Hospital Seattle Washington
United States University of Washington Seattle Washington
United States Baystate Medical Center Springfield Massachusetts
United States SSM Cardinal Glennon Children's Medical Center St. Louis Missouri
United States St. Louis Children's Hospital St. Louis Missouri
United States Children's Hospital at St. Francis Tulsa Oklahoma
United States Children's National Medical Center Washington District of Columbia
United States Washington Hospital Center Washington DC District of Columbia
United States Wake Forest University Baptist Medical Center Winston Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

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