NCT03938480

Brief Summary

Intraoperative hypotension is common in non cardiac surgery. longer duration of intraoperative hypotension is related with postoperative morbidity and mortality. however, with the change of hypotension criteria, the duration threshold also change. the relationship of different hypotension criteria and its duration is unclear. This study is to explore the their relationship.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 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, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2019

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2019

Completed
Last Updated

June 4, 2019

Status Verified

June 1, 2019

Enrollment Period

5 months

First QC Date

May 2, 2019

Last Update Submit

June 3, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • major adverse events

    including acute cardiac infarction, heart failure, cardiac death, stroke, kidney injury

    30 days postoperatively in hospital

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The analysis set of this study was adults (age ≥ 18 years old) who underwent elective non-cardiac surgery from January 1, 2012, to December 31, 2017.

You may qualify if:

  • adults underwent elective non-cardiac surgery

You may not qualify if:

  • cardiac surgeries; kidney surgeries; obstetric surgeries; local infiltration anesthesia; surgeries without arterial pressure monitoring; perioperative data missing; patients with more than one operation within a year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PKU 1st hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

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

Study Record Dates

First Submitted

May 2, 2019

First Posted

May 6, 2019

Study Start

January 1, 2019

Primary Completion

May 20, 2019

Study Completion

May 22, 2019

Last Updated

June 4, 2019

Record last verified: 2019-06

Locations