NCT03654456

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2019

Completed
Last Updated

May 16, 2019

Status Verified

May 1, 2019

Enrollment Period

12 months

First QC Date

July 24, 2018

Last Update Submit

May 14, 2019

Conditions

Keywords

obstructive sleep apneasepsisoutcomeprognosissleep-disordered breathing

Outcome Measures

Primary Outcomes (1)

  • Mortality

    percentage of sepsis patients died of sepsis

    up to 40 days

Secondary Outcomes (3)

  • Survival time

    up to 40 days

  • Mortality

    7-day

  • Mortality

    28-day

Study Arms (2)

Sepsis patients with OSA

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

Biological: OSA

Sepsis patients without OSA

Sepsis patients who received a prior polysomnography showing an apnea-hypopnea index less than 5/hr

Interventions

OSABIOLOGICAL

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

Sepsis patients with OSA

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Younger than 20 years
  • Not compatible with a definition of sepsis
  • subjects with incomplete data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

Related Publications (2)

  • 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.

    PMID: 12682500BACKGROUND
  • 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.

MeSH Terms

Conditions

Sleep Apnea SyndromesSepsisSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kun-Ta Chou, M.D

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun-Ta Chou, M.D

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2018

First Posted

August 31, 2018

Study Start

May 28, 2018

Primary Completion

May 27, 2019

Study Completion

May 27, 2019

Last Updated

May 16, 2019

Record last verified: 2019-05

Locations