Personalized Blood Pressure Management

Blood Pressure Clinical Trial

— IMPROVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03442907
• Other study ID #: IMPROVE-1.0
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: January 2021
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: January 31, 2020
• Est. primary completion date: October 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Hypotension
• Intraoperative Hypotension
• Postoperative Complications

Intervention

Procedure:
• 24 hour blood pressure measurement, fluids, vasopressors
Targeting individual blood blood pressure values during surgical procedures
• Standard of Care
Treatment according to Standard of care at the Department of Anaesthesiology, University Medical Centre Hamburg Eppendorf

Locations

Country	Name	City	State
Germany	Klinik und Poliklinik für Anästhesiologie, Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

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