Avoidance of Delirium in Older Patients After Major Non-cardiac Surgery

NCT ID: NCT01827501

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2021-02-28

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

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%).

Conditions

Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group GDT

Goal-directed Management according to pulse contour analysis (PulsioflexTM Monitoring)

Group Type: EXPERIMENTAL

PulsioflexTM Monitoring

Intervention Type: DEVICE

Fluid and catecholamine management according to PulsioflexTM measurements

Group Co

Conventional fluid management

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PulsioflexTM Monitoring

Fluid and catecholamine management according to PulsioflexTM measurements

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bettina Jungwirth, MD

Role: PRINCIPAL_INVESTIGATOR

Klinik für Anaesthesiologie Technische Universität München

Locations

Klinik für Anästhesiologie Klinikum Rechts der Isar

Munich, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 22669559 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35935775 (View on PubMed)

Other Identifiers

ADOM

Identifier Type: -

Identifier Source: org_study_id