Novel Influenza A Surveillance Registry (H1N1)
Clinical Trials URL:
Study Type: Epidemiology Study
Prepared on August 14, 2012
Last Updated on August 15, 2012
Study Dates: October 2009 –October 2010
Consent: Unrestricted Consent
Commercial Use Restrictions: No
NHLBI Division: DLD
Collection Type: Open BioLINCC Study - See bottom of this webpage for request information
The purpose of this prospective surveillance registry was to characterize the demographics, clinical features, outcomes, and resource utilization of adult patients with H1N1 influenza infection who require intensive care.
There are no pertinent animal studies of H1N1 influenza. Human studies are limited to case reports or case series which report on relatively limited number of patients. These reports suggest that although severe disease requiring critical care is rare among patients with H1N1 infection, the patients who do require ICU care have a rapidly progressive course with high disease severity. Unlike typical influenza, where the extremes of age (i.e. elderly and very young) and those with underlying cardiopulmonary comorbidities are at increased risk of developing severe and potentially fatal infections, young otherwise healthy patients (including children of all ages), obese patients, and pregnant females appear to be at an increased risk for severe disease from the novel influenza A (H1N1) virus.
The study data consists of 892 subjects who were admitted to an intensive care unit at a participating site with confirmed or suspected Novel H1N1 Influenza infection. Subjects with influenza-like illness due to non-influenza disease and negative testing for influenza were excluded. This study does not include the data collected from a parallel study of children (<21 years of age) with confirmed or probable H1N1 virus; however, there are some patients less than 21 years of age in the dataset.
Patients were enrolled on the day of ICU admission and baseline demographics collected from the medical record. The presenting clinical features and lab values for organ function were also collected. APACHE III (or PRISM for children) and Sepsis-related Organ Failure Assessment (SOFA) scores were calculated for data present in the medical record on enrollment. Crude outcomes were collected weekly in order to have a real-time picture of the clinical course. At ICU discharge, death or day 28, more in-depth outcomes were collected. 60-day followup was collected for patients who remained hospitalized beyond day 28. In children remaining hospitalized beyond day 60, this information was collected at day 90. Cause of death was requested.