Personalized Blood Pressure Management

Not Applicable

Completed

• Conditions: Blood Pressure; Intraoperative Hypotension; Postoperative Complications

• Registration Number: NCT03442907
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-19
• Study First Submitted QC: 2018-02-16
• Study First Posted: 2018-02-22
• Study Start: 2018-03-01
• Primary Completion: 2019-10-10
• Study Completion: 2020-01-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-23
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 368

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
• Impossibility of 24-h blood pressure measurement

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite endpoint: Incidence of POCD or delirium	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 Outcome Measures

Name	Time	Method
Kidney function	24, 48 and 72 hrs after surgery	Glomerular filtration rate; calculated 24h, 48h and 72h after surgery (Cockcroft-Gault equation)
cardiac ischemia	6 hours after surgery	high-sensitive troponin T measurements are performed prior and 6 hours after surgery
length of hospital stay	30 days
30-day morbidity	30 days	European perioperative outcome definitions
30-day mortality	30 days

Trial Locations

Locations (1)

Klinik und Poliklinik für Anästhesiologie, Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany