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Personalized Blood Pressure Management (IMPROVE)

Primary Purpose

Blood Pressure, Intraoperative Hypotension, Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
24 hour blood pressure measurement, fluids, vasopressors
Standard of Care
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Pressure

Eligibility Criteria

50 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study group

Control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 19, 2018
Last Updated
January 23, 2021
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT03442907
Brief Title
Personalized Blood Pressure Management
Acronym
IMPROVE
Official Title
Intraoperative Blood Pressure Management Based on the Individual Blood Pressure Profile: Impact on Postoperative Organ Function
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
October 10, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Intraoperative Hypotension, Postoperative Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
368 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
24 hour blood pressure measurement, fluids, vasopressors
Intervention Description
Targeting individual blood blood pressure values during surgical procedures
Intervention Type
Procedure
Intervention Name(s)
Standard of Care
Intervention Description
Treatment according to Standard of care at the Department of Anaesthesiology, University Medical Centre Hamburg Eppendorf
Primary Outcome Measure Information:
Title
Composite endpoint: Incidence of POCD or delirium
Description
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 Outcome Measure Information:
Title
Kidney function
Description
Glomerular filtration rate; calculated 24h, 48h and 72h after surgery (Cockcroft-Gault equation)
Time Frame
24, 48 and 72 hrs after surgery
Title
cardiac ischemia
Description
high-sensitive troponin T measurements are performed prior and 6 hours after surgery
Time Frame
6 hours after surgery
Title
length of hospital stay
Time Frame
30 days
Title
30-day mortality
Time Frame
30 days
Title
30-day morbidity
Description
European perioperative outcome definitions
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Klinik und Poliklinik für Anästhesiologie, Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

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Personalized Blood Pressure Management

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