NCT03803813

Brief Summary

To investigate the incidence and outcome of sepsis in critical patients undergoing craniotomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
907

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2017

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2018

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

August 5, 2021

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

December 26, 2018

Last Update Submit

August 3, 2021

Conditions

Sepsis

Keywords

sepsisseptic shockinfectioncraniotomyoutcome

Outcome Measures

Primary Outcomes (1)

  • Incidence of sepsis

    The incidence of sepsis in critical patients undergoing craniotomy

    28 days

Study Arms (2)

sepsis group

Patients have developed sepsis at ICU admission or during their ICU stay.

non-sepsis group

Patients do not develope sepsis at ICU admission or during their ICU stay.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients over 18 years of age and have undergone craniotomy in intensive care will be screened for sepsis at admission or during their ICU stay, whereas those who stay in the ICU for \<24 hrs for routine postoperative surveillance will be excluded.

You may qualify if:

  • years or older
  • ICU length of stay ≥ 24 hours
  • after craniotomy

You may not qualify if:

  • \<18 years
  • ICU length of stay \< 24 hours
  • Patients or their immediate family members refuse to participate in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tian Tan hospital

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

SepsisShock, SepticInfections

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Jian-Xin Zhou, MD

    Beijing Tiantan Hospital, Capital Medical Universtity

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 26, 2018

First Posted

January 15, 2019

Study Start

January 1, 2017

Primary Completion

December 31, 2018

Study Completion

June 30, 2020

Last Updated

August 5, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)