Personalized Blood Pressure Management

Study Overview
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Brief Summary
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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.

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

Conditions
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Blood Pressure, Intraoperative Hypotension, Postoperative Complications

Intervention / Treatment
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* Procedure: 24 hour blood pressure measurement, fluids, vasopressors
* Procedure: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria age ≥ 50 years ASA II-IV (Classification of the American Society of Anesthesiologists for the assessment of the perioperative risk depending on the underlying diseases) duration of intervention in general anesthesia at least 90 minutes 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>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. | Procedure: 24 hour blood pressure measurement, fluids, vasopressors<br>* Targeting individual blood blood pressure values during surgical procedures<br>|
| Active Comparator: Control group<br>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. | Procedure: Standard of Care<br>* Treatment according to Standard of care at the Department of Anaesthesiology, University Medical Centre Hamburg Eppendorf<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint: Incidence of POCD or delirium | POCD is measured on the basis of a neuropsychological test battery and the delirium on the basis of the CAM-ICU test. | 3rd-7th postoperative day | 

Secondary Outcome Measures

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