Epidemiological Investigation of Sepsis in Obstetrics Admitted to ICU

Sponsor
Peking University Third Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05055388
Collaborator
Beijing Chao Yang Hospital (Other), Beijing Friendship Hospital (Other)
160
1
17.9
9

Study Details

Study Description

Brief Summary

Sepsis is still the main cause of maternal death, accounting for 11% of maternal deaths. Early identification of high risk factors of sepsis and early intervention can improve the prognosis of pregnant women with sepsis. At present, there is no epidemiological investigation report on sepsis in ICU in China.

Condition or Disease Intervention/Treatment Phase
  • Other: Multidrug-resistant bacteria

Detailed Description

Although great progress has been made in maternal care in China in recent years, the maternal mortality rate in China has remained high in the past three years, fluctuating from 19.6-20.1/100000, and there is still a large gap between China and developed countries (12.1/100000). Sepsis is still the main cause of maternal death, accounting for 11% of maternal deaths; Early identification of high risk factors of sepsis and early intervention can improve the prognosis of pregnant women with sepsis. At present, there is no epidemiological investigation report on sepsis in ICU in China. A total of 160 cases of maternal sepsis with ICU admission in any trimester of pregnancy or within 42 days of delivery were reviewed between January 1, 2008, and December 31, 2019. The demographic data including age and gestational age, mode of delivery, the maximal SOFA score, invasive operation before sepsis, sepsis focuses, intervention, microbial culture results, body temperature and blood routine were reviewed to investigate the incidence and mortality of maternal sepsis in intensive care unit, as well as the incidence of multidrug-resistant bacteria and the risk factors of multidrug resistance.

Study Design

Study Type:
Observational
Anticipated Enrollment :
160 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Epidemiological Investigation of Sepsis in Obstetrics Admitted to ICU From 2008 to 2016 in Beijing China: A First Multicenter Report
Actual Study Start Date :
Dec 3, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
May 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Group with sepsis complicated with multidrug-resistant bacteria

Obstetrics diagnosed with sepsis were divided to group with sepsis complicated with multidrug-resistant bacteria if microbial culture results showed multidrug-resistance.

Other: Multidrug-resistant bacteria
Multidrug resistance was defined as acquired non-susceptibility to at leas one agent in three or more antimicrobial categories.

Group with sepsis complicated with none multidrug-resistant bacteria

Obstetrics diagnosed with sepsis were divided to group with sepsis complicated with none multidrug-resistant bacteria if microbial culture results showed none-multidrug-resistance or no positive result of microbial culture.

Outcome Measures

Primary Outcome Measures

  1. The incidence of Maternal sepsis in intensive care unit [January 2008 to December 2019]

    The incidence of Maternal sepsis in ICU represents as proportion based on the total number of of maternal ICU admissions and is expressed per 100 deliveries.

  2. Sepsis related maternal mortality [January 2008 to December 2019]

    Sepsis related maternal mortality in hospitals represents as proportion based on the total number of maternal sepsis in intensive care units and is expressed per 100,000 deliveries.

  3. The incidence of multidrug resistance [January 2008 to December 2019]

    The incidence of multidrug resistance represents as proportion based on the total number of of maternal sepsis in ICU and is expressed per 100 deliveries. Multidrug resistance was defined as acquired non-susceptibility to at leas one agent in three or more antimicrobial categories.

Secondary Outcome Measures

  1. The length of ICU stay [January 2008 to December 2019]

    The date of transferring to wards or death minus the date of ICU admission

  2. Hospital length [January 2008 to December 2019]

    Discharge date minus admission date

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No

Inclusion Criteria: Obstetrics with sepsis in any trimester of pregnancy or within 42 days of delivery -

Exclusion Criteria: The electronic medical record is lost. Patients with incomplete infection data: if the temperature sheet is ambiguous and the temperature data is not recorded in the medical record.

-

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University Third Hospital Beijing Beijing China 100191

Sponsors and Collaborators

  • Peking University Third Hospital
  • Beijing Chao Yang Hospital
  • Beijing Friendship Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhao Zhiling, Deputy chief doctors, Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT05055388
Other Study ID Numbers:
  • LM2020443
First Posted:
Sep 24, 2021
Last Update Posted:
Sep 24, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 24, 2021