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Clinical Trials/NCT03442907
NCT03442907
Completed
N/A

Intraoperative Blood Pressure Management Based on the Individual Blood Pressure Profile: Impact on Postoperative Organ Function

Universitätsklinikum Hamburg-Eppendorf1 site in 1 country368 target enrollmentMarch 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Blood Pressure
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Enrollment
368
Locations
1
Primary Endpoint
Composite endpoint: Incidence of POCD or delirium
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The aim of this research project is to find out whether a personalized definition of the lower blood pressure threshold based on the individual blood pressure profile by means of preoperative 24-hour blood pressure measurement can reduce organ damage (brain, kidney, heart) through reduced blood flow during surgery.

Registry
clinicaltrials.gov
Start Date
March 1, 2018
End Date
January 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Pregnancy
  • Emergency procedures
  • Surgery requiring controlled hypotension (e.g., aneurysm)
  • Cerebrovascular events in the past medical history
  • Patients of cardiac surgery, vascular surgery, neurosurgery, and transplantation surgery
  • Pre-existing dementia (anamnesis)
  • kidney transplant
  • dialysis-dependent renal insufficiency (KDIGO criteria)
  • no patient consent
  • failure to meet the inclusion criteria

Outcomes

Primary Outcomes

Composite endpoint: Incidence of POCD or delirium

Time Frame: 3rd-7th postoperative day

POCD is measured on the basis of a neuropsychological test battery and the delirium on the basis of the CAM-ICU test.

Secondary Outcomes

  • Kidney function(24, 48 and 72 hrs after surgery)
  • cardiac ischemia(6 hours after surgery)
  • length of hospital stay(30 days)
  • 30-day morbidity(30 days)
  • 30-day mortality(30 days)

Study Sites (1)

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