Impact of Sleep Apnea on Sepsis Mortality

• Conditions: Sleep Apnea Syndromes; Mortality; Sepsis
• Interventions: Biological: OSA

• Registration Number: NCT03654456
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Study Timeline

• Study Start: 2018-05-28
• Study First Submitted: 2018-07-24
• Study First Submitted QC: 2018-08-28
• Study First Posted: 2018-08-31
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-16
• Primary Completion: 2019-05-27
• Study Completion: 2019-05-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sepsis patients with OSA	OSA	Sepsis patients who received a prior polysomnography showing an apnea-hypopnea index at least 5/hr with compatible symptoms

Primary Outcome Measures

Name	Time	Method
Mortality	up to 40 days	percentage of sepsis patients died of sepsis

Secondary Outcome Measures

Name	Time	Method
Mortality	28-day	percentage of sepsis patients died of sepsis
Survival time	up to 40 days	Survival time is defined as the length from the date when sepsis is diagnosed to date of discharge or death

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan