Personalized Blood Pressure Management (IMPROVE)

U

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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