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?

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

Study Overview

• Status: Completed
• Conditions: Delirium
• Intervention / Treatment: Device: PulsioflexTM Monitoring

Detailed Description

Delirium is a common postoperative complication in the elderly. The incidence depends on several factors like the comorbidities of the patient and the type of surgery. Mortality is almost twofold increased after two years for patients suffering from delirium after surgery. Different studies showed that with a multimodal strategy it was possible to reduce the risk of delirium. As several different organ systems are involved in the development of delirium the patient's hemodynamic state seems to be important and is a target point of intervention. Also sufficient perfusion and oxygen delivery is essential in order to avoid impairment of the brain. Recent studies showed that goal directed hemodynamic management can reduce all kind of postoperative complications and improve outcome. However, whether the use of goal-directed hemodynamic management also improves the neurological outcome and reduces the rates of postoperative delirium has not been studied yet.

Aim of this study is to investigate the impact of goal directed hemodynamic management using pulse contour analysis on the incidence of delirium in older patients undergoing non-cardiac surgery, presenting with an intermediate to high risk for delirium. This risk will be assessed preoperatively using a score suggested by Marcantonio.

Patients will be randomized in one of two groups, the goal-directed therapy group and the control group. In the goal-directed therapy (GDT) group hemodynamic management is performed according to an established algorithm obtained by pulse contour analysis. To prove our theory that goal-directed therapy influences the brain by increasing oxygen supply we will use near infrared spectroscopy, which is safe and non-invasive, in our patients. The hemodynamic management is continued in the recovery room or at the intensive care unit according to the mentioned algorithm. The intervention will be terminated as soon as patients fulfil the standard criteria for discharge from recovery room or intensive care.

In the control group hemodynamic management is performed according to heart rate and blood pressure without using extended monitoring.

As the actual incidence has a significant impact on the number needed per group, we are going to perform an interims analysis after 100 included patients according to the O'Brian-Fleming technique. Is the difference of delirium between the two groups significant with an α < 0,002 the study will be finished. Otherwise, the sample size needed per group will be determined assuming an α = 0,048, a two-tailed test and a power of 80%.

UPDATE 19-10-2016:

The interims-analysis of incidences after 100 patients revealed, that 86 patients per group will be needed (α = 0,048, power 80%).

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 81675
    • Klinik für Anästhesiologie Klinikum Rechts der Isar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 70 years
• Risk of perioperative delirium (Marcantonio) ≥6

Exclusion Criteria:

• Emergency surgery
• Valvular disorders grad II or higher
• History of major aortic surgery
• Major aortic surgery
• Repeated surgery (within 30 days before)
• Neurosurgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group GDT; Goal-directed Management according to pulse contour analysis (PulsioflexTM Monitoring)	Device: PulsioflexTM Monitoring; Fluid and catecholamine management according to PulsioflexTM measurements
No Intervention: Group Co; Conventional fluid management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors defining delirium	Duration of delirium, total amount of haloperidol administered	7 days
Short-term cognitive impairment	Mini Mental State on day 7	7 days
Mortality	in-hospital mortality, mortality after one year	1 year
Influence on brain oxygen saturation	Influence of GDT on the frontal oxygen saturation of the brain assessed with Near-InfraRed-Spectroscopy (NIRS)-Monitoring	until discharge from recovery room/ICU
Intra- and postoperative Measurements	Time until discharge, total fluids and amount of catecholamines administered, incidence of overall postoperative complications	Until discharge

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Investigators: Principal Investigator: Bettina Jungwirth, MD, Klinik für Anaesthesiologie Technische Universität München

Publications and helpful links

General Publications

• 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.
• Fuest 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: April 4, 2013
• First Submitted That Met QC Criteria: April 4, 2013
• First Posted (Estimate): April 9, 2013

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: postoperative delirium; hemodynamic management; goal directed therapy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: ADOM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No