Personalized Blood Pressure Management

Universitätsklinikum Hamburg-Eppendorf368 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

368

Conditions

Blood Pressure Intraoperative Hypotension Postoperative Complications

Interventions

24 hour blood pressure measurement, fluids, vasopressorsPROCEDURE

Targeting individual blood blood pressure values during surgical procedures

Standard of CarePROCEDURE

Treatment according to Standard of care at the Department of Anaesthesiology, University Medical Centre Hamburg Eppendorf

Eligibility

Sex: ALLMin age: 50 YearsMax age: 110 Years

Medical Language ↔ Plain English

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

Locations (1)

Klinik und Poliklinik für Anästhesiologie, Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Outcomes

Primary Outcomes

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.

Time frame: 3rd-7th postoperative day

Secondary Outcomes

Kidney function

Glomerular filtration rate; calculated 24h, 48h and 72h after surgery (Cockcroft-Gault equation)

Time frame: 24, 48 and 72 hrs after surgery

cardiac ischemia

high-sensitive troponin T measurements are performed prior and 6 hours after surgery

Time frame: 6 hours after surgery

length of hospital stay

Time frame: 30 days

30-day mortality

Time frame: 30 days

30-day morbidity

European perioperative outcome definitions

Time frame: 30 days

Data from ClinicalTrials.gov

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