Personalized Blood Pressure Management (IMPROVE)

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Postoperative Complications; Intraoperative Hypotension; Blood Pressure

Treatments: Procedure: Standard of Care; Procedure: 24 hour blood pressure measurement, fluids, vasopressors

Study type: Interventional

Funder types: Other

Identifiers

NCT03442907

IMPROVE-1.0

Details and patient eligibility

About

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.

Enrollment: 368 patients

Sex: All

Ages: 50 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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368 participants in 2 patient groups

Study group

Experimental group

Description:

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.

Treatment:

Procedure: 24 hour blood pressure measurement, fluids, vasopressors

Control group

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard of Care