Study of Prevention of Postoperative Delirum to Reduce Incidence of Postoperative Cognitive Dysfunction

NCT03060174 | Completed

• 1 other identifier: PV4654
• Study Type: interventional
• Target: 638
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative cognitive dysfunction describes a condition where cognitive functions such as attention, perception, concentration, learning, abstract thinking and problem solving are impaired postoperatively. These changes can be resolved after weeks and months, but in some cases may be permanent. The aetiology is multifactorial. One risk factor for developing POCD is the occurrence of postoperative delirium. A total of 638 consecutive patients will be enrolled in the study. Patients will be followed up at 7 days, 3 months and 1 year postoperatively. The cognitive function will be tested and compared to tests done before surgery. Postoperatively (from the day of operation until the 7th day and except of day 6) the grade of sedation; agitation; signs of delirium; pain; cardiac; respiratory; renal and infectious complications will be recorded. As possible influencing factors, the investigators will document diagnosed depression; comorbidities; intraoperative blood loss; length of hospital stay; 1-year-mortality; number of operations/anaesthetics undergone after the initial operation. Parameters that could trigger either depressive symptoms, neurocognitive dysfunction, anxiety, fatigue or lack of concentration will be recorded. These include: anaemia, hypercalcaemia, thyroidal gland hormones, electrolytes, creatinine, urea, glomerular filtration rate, cortisone therapy and adrenal cortical insufficiency.

Conditions

Postoperative Cognitive Dysfunction; Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• postoperative cognitive deficit (POCD)

  measured by neuropsychological test battery, analysis

  change from baseline in cognitive function at day 7, 3 months and 1 year after operation

Secondary Outcomes (8)

• incidence and severity of postoperative delirium

  from the day of operation until the 7th postoperative day

• number of patients with cardiac complications

  day of operation until 7th postoperative day

• length of hospital stay

  from day of admission until day of discharge, up to 24 weeks

• mortality

  1 year

• health related quality of life

  3 months, 1 year after operation

Other Outcomes (4)

• anxiety and depressive symptoms on HADS-D

  7 days, 3 months, 1 year after operation

• postoperative pain scores on the numeric rating scale (NRS)

  day of operation until 7th postoperative day, 3 months, 1 year after operation

• haemoglobin (Anaemia) on a score

  intraoperative

Study Arms (2)

monitoring and non-medical prophylaxis of delirium

OTHER

The treatment group will receive monitoring and prophylaxis of delirium. The study arm designed to prevent delirium incorporates reorientation (watches, calendar, family photos, use of hearing aids, glasses and dentures, cognitive stimulation (newspaper, magazines, radio, television), early mobilisation, early enteral nutrition, early removal of drains or catheters, normalizing sleep-awake-rhythm.

Other: monitoring and non-medical prophylaxis of delirium

Standard

NO INTERVENTION

The standard group will receive standard monitoring and standard treatment. The indication, choice and dosage of the medication used to treat delirium will be at the discretion of the ward doctor and will not be influenced by this study. The chosen medication as well as its dosage will be documented.

Interventions

monitoring and non-medical prophylaxis of delirium OTHER

monitoring and non-medical prophylaxis of delirium

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 60 years
• Cardiac surgery (on-pump/off-pump, standard/minimal invasive)
• Written informed patient's consent

You may not qualify if:

• Non-German speaking or not their first language
• Illiteracy
• Mental disability
• Non-corrigible vision impairment
• Non-corrigible hearing impairment
• Illegal substance abuse (current or past history)
• Alcohol abuse (current or past history)
• Chronic benzodiazepine use
• Psychosis (current or past history)
• Parkinson Disease
• Dementia
• Multiple sclerosis
• Epilepsy (current or past history)
• Cerebral tumor (current or past history)
• Apoplexy or intracranial bleeding (current or past history)

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Department of Anaesthesiology and Intensive Care Medicine, University Hospital Hamburg Eppendorf, Univ.-Prof. Dr. med. Alwin E. Goetz and Prof. Dr. med. Christian Zoellner

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications; Emergence Delirium

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: February 23, 2017
• Study Start: May 1, 2014
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-10

Locations

DE (1)