Impact of Sleep Apnea on Sepsis Mortality

Sepsis Clinical Trial

Official title:

The Impact of Sleep Apnea on the Mortality of Sepsis - A Retrospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03654456
• Other study ID #: 2018-06-019AC
• Status: Recruiting
• Start date: May 28, 2018
• Est. completion date: May 27, 2019

Study information

• Verified date: May 2019
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Kun-Ta Chou, M.D
• Phone: 886922407055
• Email: ale1371[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: May 27, 2019
• Est. primary completion date: May 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Mortality
• Sepsis
• Sleep Apnea Syndromes
• Toxemia

Intervention

Biological:
• OSA
The diagnosis of OSA (obstructive sleep apnea) relies on polysomnographic data showing an apnea-hypopnea index at least 5/hr with compatible symptoms.

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	percentage of sepsis patients died of sepsis	up to 40 days
Secondary	Survival time	Survival time is defined as the length from the date when sepsis is diagnosed to date of discharge or death	up to 40 days
Secondary	Mortality	percentage of sepsis patients died of sepsis	7-day
Secondary	Mortality	percentage of sepsis patients died of sepsis	28-day