NCT04117867

Brief Summary

The aim of this study is to investigate the association between the severity and duration of intraoperative hypotension and the incidence of perioperative stroke after non-cardiac and non-neurologic surgeries.The secondary aim of this study is to confirm the potential risk factors of the perioperative stroke.

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
70,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 7, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

December 30, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

December 4, 2020

Status Verified

December 1, 2020

Enrollment Period

1.8 years

First QC Date

September 27, 2019

Last Update Submit

December 3, 2020

Conditions

Perioperative ComplicationIntraoperative Hypotension

Outcome Measures

Primary Outcomes (4)

  • Incidence of perioperative stroke

    Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs

    Within 24 hours after surgery

  • Incidence of perioperative stroke

    Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs

    Within 3 days after surgery

  • Incidence of perioperative stroke

    Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs

    Within 7 days after surgery

  • Incidence of perioperative stroke

    Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs

    Within 30 days after surgery

Secondary Outcomes (5)

  • Rate of death

    Within 24 hours after surgery

  • Rate of death

    Within 3 days after surgery

  • Rate of death

    Within 7 days after surgery

  • Rate of death

    Within 30 days after surgery

  • Expense of Healthe care and social service

    Through study completion, an average of 14 days

Study Arms (1)

Intraoperative hypotension

Behavioral: Patiens with intraoperative hypotension

Interventions

Patiens with intraoperative hypotensionBEHAVIORAL

In this study, we will use four previously defined thresholds for intraoperative hypotension: two absolute thresholds (MAP less than 50 mmHg and MAP less than 60 mmHg) and two relative thresholds to the baseline MAP (a decrease of 30% or more and a decrease of 40% or more). A definition of baseline value most frequently reported was the arterial blood pressure before the induction of anesthesia. Therefore, the baseline MAP used in calculating the relative thresholds is defined as the mean MAP of all available blood pressure measurements before induction of anesthesia in the operating room.

Intraoperative hypotension

Eligibility Criteria

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

All patients who underwent surgical procedures under anesthesia at Qianfoshan Hospital, First Hospital affiliated to Shandong First Medical University during the period from January, 2013, to October, 2019, will be included.

You may qualify if:

  • Patients underwent surgeries in First hospital affiliated to Shandong First Medical University from January 2013 to October 2019
  • Age\>18 or older

You may not qualify if:

  • Patients received local infiltration anesthesia
  • Patients underwent total intravenous anesthsia without tracheal intubation or Laryngeal Mask Airway insertion
  • Major vascular operation
  • Neurologic surgery
  • Cariac surgery
  • Intraoperative blood pressure measurements or postoperative neuroimagings measurements are not available
  • History of severe neurological or psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First affiliated hospital of Shandong First Medical University

Jinan, Shandong, China

RECRUITING

Study Officials

  • Yuelan Wang, Doctor

    Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuelan Wang, Doctor

CONTACT

+86053189268535qylvmeng@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 27, 2019

First Posted

October 7, 2019

Study Start

December 30, 2019

Primary Completion

November 1, 2021

Study Completion

November 1, 2022

Last Updated

December 4, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

CN(1)