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Personalized Blood Pressure Management (IMPROVE)

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ClinicalTrials.gov Identifier: NCT03442907
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

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.

Condition or disease Intervention/treatment Phase
Blood Pressure Intraoperative Hypotension Postoperative Complications Procedure: 24 hour blood pressure measurement, fluids, vasopressors Procedure: Standard of Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 368 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraoperative Blood Pressure Management Based on the Individual Blood Pressure Profile: Impact on Postoperative Organ Function
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : October 31, 2019

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




Primary Outcome Measures :
  1. Composite endpoint: Incidence of POCD or delirium [ Time Frame: 3rd-7th postoperative day ]
    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 :
  1. Kidney function [ Time Frame: 24, 48 and 72 hrs after surgery ]
    Glomerular filtration rate; calculated 24h, 48h and 72h after surgery (Cockcroft-Gault equation)

  2. cardiac ischemia [ Time Frame: 6 hours after surgery ]
    high-sensitive troponin T measurements are performed prior and 6 hours after surgery

  3. length of hospital stay [ Time Frame: 30 days ]
  4. 30-day mortality [ Time Frame: 30 days ]
  5. 30-day morbidity [ Time Frame: 30 days ]
    European perioperative outcome definitions



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Ages Eligible for Study:   50 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442907


Contacts
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Contact: Julia Nicklas, Dr +4940741018867 j.nicklas@uke.de
Contact: Bernd Saugel, Dr +4940741018866 b.saugel@uke.de

Locations
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Germany
Klinik und Poliklinik für Anästhesiologie, Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Bernd Saugel, MD    +4940741018866    b.saugel@uke.de   
Contact: Julia Nicklas, MD    +4940741018867    j.nicklas@uke.de   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03442907     History of Changes
Other Study ID Numbers: IMPROVE-1.0
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hypotension
Postoperative Complications
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Vasoconstrictor Agents