Clinical trial NCT03654456: Impact of Sleep Apnea on Sepsis Mortality
Official title: The Impact of Sleep Apnea on the Mortality of Sepsis - A Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea Syndromes
Sepsis
Mortality
Keywords: obstructive sleep apnea
sepsis
outcome
prognosis
sleep-disordered breathing
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2018-08-31
Enrollment: 280
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sepsis Patients who had received a polysomnography at Taipei Veterans General Hospital during Jan. 1, 2001 to May 31, 2017 will be enrolled.

Brief summary: By clinical record review, this retrospective study aims to compare the mortality of sepsis patients with versus without obstructive sleep apnea, who were diagnosed and treated in Taipei Veterans General Hospital, Taiwan.

Detailed description: This retrospective study aims to compare the mortality of sepsis patients with versus without obstructive sleep apnea (OSA). Patients with a diagnosis of sepsis, who had received a prior polysomnography at Taipei Veterans General Hospital during Jan. 1, 2001 to May 31, 2017 will be enrolled. Obstructive sleep apnea (OSA) is defined by an apnea-hypopnea index at least 5/hr with compatible symptoms. Their clinical record will be reviewed and data including demography, polysomnography and details related to sepsis (source of infection, number of organ dysfunction at initial diagnosis of sepsis and survival time) will be collected. The start of the survival time (follow-up time) is the date when sepsis is diagnosed. The end of the survival time (follow-up time) is the date of death or end of hospitalization (date of discharge). Survival analyses will be performed.

Eligibility criteria: Inclusion Criteria:

1. Patients who received received a polysomnography at Taipei Veterans General Hospital during Jan. 1, 2001 to May 31, 2017
2. Patients who were admitted with a diagnosis of sepsis after the polysomnography
3. The diagnosis of sepsis fulfilling the clinical criteria

Exclusion Criteria:

1. Younger than 20 years
2. Not compatible with a definition of sepsis
3. subjects with incomplete data

Primary outcomes:
measure: Mortality
timeFrame: up to 40 days
Secondary outcomes:
measure: Survival time
timeFrame: up to 40 days
measure: Mortality
timeFrame: 7-day
measure: Mortality
timeFrame: 28-day
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Kun-Ta Chou, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; SCCM/ESICM/ACCP/ATS/SIS. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med. 2003 Apr;31(4):1250-6. doi: 10.1097/01.CCM.0000050454.01978.3B.
citation: Huang CY, Chen YT, Wu LA, Liu CJ, Chang SC, Perng DW, Chen YM, Chen TJ, Lee YC, Chou KT. Sleep apnoea patients have higher mortality when confronting sepsis. Eur J Clin Invest. 2014 Jan;44(1):38-45. doi: 10.1111/eci.12187. Epub 2013 Nov 11.