Personalized Blood Pressure Management (IMPROVE)

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

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 Overview

• Status: Completed
• Conditions: Postoperative Complications; Blood Pressure; Intraoperative Hypotension
• Intervention / Treatment: Procedure: 24 hour blood pressure measurement, fluids, vasopressors; Procedure: Standard of Care

• Study Type: Interventional
• Enrollment (Actual): 368
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Klinik und Poliklinik für Anästhesiologie, Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; 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; Targeting individual blood blood pressure values during surgical procedures
Active Comparator: Control group; 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; Treatment according to Standard of care at the Department of Anaesthesiology, University Medical Centre Hamburg Eppendorf

What is the study measuring?

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
30-day mortality		30 days
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 morbidity	European perioperative outcome definitions	30 days

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): October 10, 2019
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 23, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hypotension; Postoperative Complications; Vasoconstrictor Agents
• Other Study ID Numbers: IMPROVE-1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No