Personalized Blood Pressure Management

Not Applicable

Completed

• Conditions: Blood Pressure; Intraoperative Hypotension; Postoperative Complications
• Interventions: Procedure: 24 hour blood pressure measurement, fluids, vasopressors; Procedure: Standard of Care

• 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

Arm && Interventions

Group	Intervention	Description
Study group	24 hour blood pressure measurement, fluids, vasopressors	The intraoperative blood pressure target for all patients in the study group is the mean arterial pressure (+ 10mmHg maximum) derived from the prior 24-hour blood pressure measurement. To achieve the blood pressure target, fluid or vasoactive substances will be used.
Control group	Standard of Care	Study patients of the control group are treated according to the standard operating procedures (SOP) of the Department of Anaesthesiology, University Medical Centre Hamburg Eppendorf.

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