Avoidance of Delirium in Older Patients After Major Non-cardiac Surgery
ADOM
Can Perioperative Goal Directed Hemodynamic Management Reduce the Incidence of Delirium in Older Patients After Major Non-cardiac Surgery?
1 other identifier
interventional
172
1 country
1
Brief Summary
This study is designed to compare the incidence of postoperative delirium in older patients after major non-cardiac surgery with different perioperative hemodynamic managements: a goal directed hemodynamic management group and a control group
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 4, 2013
CompletedFirst Posted
Study publicly available on registry
April 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedApril 8, 2021
March 1, 2021
6.7 years
April 4, 2013
April 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of delirium until day 7 (CAM-Score and clinical diagnosis)
Delirium according to CAM-Score and clinical diagnosis
Before induction of anesthesia until 7 days after surgery
Secondary Outcomes (5)
Factors defining delirium
7 days
Short-term cognitive impairment
7 days
Mortality
1 year
Influence on brain oxygen saturation
until discharge from recovery room/ICU
Intra- and postoperative Measurements
Until discharge
Study Arms (2)
Group GDT
EXPERIMENTALGoal-directed Management according to pulse contour analysis (PulsioflexTM Monitoring)
Group Co
NO INTERVENTIONConventional fluid management
Interventions
Fluid and catecholamine management according to PulsioflexTM measurements
Eligibility Criteria
You may qualify if:
- Age ≥ 70 years
- Risk of perioperative delirium (Marcantonio) ≥6
You may not qualify if:
- Emergency surgery
- Valvular disorders grad II or higher
- History of major aortic surgery
- Major aortic surgery
- Repeated surgery (within 30 days before)
- Neurosurgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinik für Anästhesiologie Klinikum Rechts der Isar
Munich, 81675, Germany
Related Publications (2)
Marcantonio ER. Postoperative delirium: a 76-year-old woman with delirium following surgery. JAMA. 2012 Jul 4;308(1):73-81. doi: 10.1001/jama.2012.6857.
PMID: 22669559BACKGROUNDFuest KE, Servatius A, Ulm B, Schaller SJ, Jungwirth B, Blobner M, Schmid S. Perioperative Hemodynamic Optimization in Patients at Risk for Delirium - A Randomized-Controlled Trial. Front Med (Lausanne). 2022 Jul 13;9:893459. doi: 10.3389/fmed.2022.893459. eCollection 2022.
PMID: 35935775DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bettina Jungwirth, MD
Klinik für Anaesthesiologie Technische Universität München
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2013
First Posted
April 9, 2013
Study Start
April 1, 2013
Primary Completion
December 1, 2019
Study Completion
February 1, 2021
Last Updated
April 8, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share