NCT03442907

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
368

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

1.6 years

First QC Date

January 19, 2018

Last Update Submit

January 23, 2021

Conditions

Blood PressureIntraoperative HypotensionPostoperative Complications

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Kidney function

    24, 48 and 72 hrs after surgery

  • cardiac ischemia

    6 hours after surgery

  • length of hospital stay

    30 days

  • 30-day mortality

    30 days

  • 30-day morbidity

    30 days

Study Arms (2)

Study group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

24 hour blood pressure measurement, fluids, vasopressorsPROCEDURE

Targeting individual blood blood pressure values during surgical procedures

Study group
Standard of CarePROCEDURE

Treatment according to Standard of care at the Department of Anaesthesiology, University Medical Centre Hamburg Eppendorf

Control group

Eligibility Criteria

Age50 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Impossibility of 24-h blood pressure measurement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hamburg, 20246, Germany

Location

Related Publications (1)

  • Nicklas JY, Bergholz A, Dake F, Pham HHD, Rabe MC, Schlichting H, Skrovanek S, Flick M, Kouz K, Fischer M, Olotu C, Izbicki JR, Mann O, Fisch M, Schmalfeldt B, Frosch KH, Renne T, Krause L, Zollner C, Saugel B. Personalised blood pressure management during major noncardiac surgery and postoperative neurocognitive disorders: a randomised trial. BJA Open. 2024 Jul 1;11:100294. doi: 10.1016/j.bjao.2024.100294. eCollection 2024 Sep.

    PMID: 39050403DERIVED

MeSH Terms

Conditions

Postoperative Complications

Interventions

Fluid TherapyVasoconstrictor AgentsStandard of Care

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsCardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2018

First Posted

February 22, 2018

Study Start

March 1, 2018

Primary Completion

October 10, 2019

Study Completion

January 31, 2020

Last Updated

January 26, 2021

Record last verified: 2021-01

Locations

DE(1)