Study of Prevention of Postoperative Delirum to Reduce Incidence of Postoperative Cognitive Dysfunction (DelPOCD)

The Influence of Non-medication-based Prophylaxis of Postoperative Delirium on Postoperative Delirium and Cognitive Deficit

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium; Postoperative Cognitive Dysfunction
• Intervention / Treatment: Other: monitoring and non-medical prophylaxis of delirium

Detailed Description

The methods include a neuropsychological test battery: TAP 2.3 (attention), Trail Making Test (TMT )A+B (attention), Digit span (memory), (Visual Learning and Memory Test (VLMT) (memory), Regensburgerwortfluessigkeitstest/fluency (RWT) subtests (executive function), Mehrfach-Wortschatz-Intelligenztest/vocabulary (MWT-B) (premorbid IQ).

Other measures are Hospital Anxiety and Depression Scale (HADS-D) (depressive symptoms and anxiety), Mini Mental State Examination (MMSE) 2 (dementia), Confusion Assessment Method (CAM-ICU) (delirium), Richmond Agitation and Sedation Scale (RASS) (sedation and agitation), Numeric Rating Scale (NRS) (pain) and Short Form Health Survey (SF-12) (health related quality of life).

• Study Type: Interventional
• Enrollment (Anticipated): 638
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Department of Anaesthesiology and Intensive Care Medicine, University Hospital Hamburg Eppendorf, Univ.-Prof. Dr. med. Alwin E. Goetz and Prof. Dr. med. Christian Zoellner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)
• Severe traumatic brain injury (current or past history)
• Severe liver disease (Child Pugh B, C, liver insufficiency)
• Severe kidney disease with dialysis
• Mini Mental Status Examination < 24 points

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: monitoring and non-medical prophylaxis of delirium; 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
No Intervention: Standard; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality		1 year
incidence and severity of postoperative delirium	measured 3 times per day via CAM-ICU	from the day of operation until the 7th postoperative day
number of patients with cardiac complications	daily documentation of cardiac complications (central venous oxygen saturation, myocardial infarction, acute heart failure, others)	day of operation until 7th postoperative day
length of hospital stay		from day of admission until day of discharge, up to 24 weeks
health related quality of life	Short Form Health Survey (SF-12)	3 months, 1 year after operation
number of patients with respiratory complications	daily documentation of pulmonary complications (pneumonia, pulmonary oedema, others),	day of operation until 7th postoperative day
number of patients with renal complications	daily documentation of renal complications (creatinine, haemo(dia)filtration or haemodialysis)	day of operation until 7th postoperative day
number of patients with complications in the immunosystem	daily documentation of parameters mirroring the immune answer (C-reactive protein, leukocytes, procalcitonin)	day of operation until 7th postoperative day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
anxiety and depressive symptoms on HADS-D	The Hospital Anxiety and Depression Scale (HADS-D) is used to measure depressive symptoms. The 7 items are answered on a 4-point scale from 0 to 3 with a scale score varying between 0 and 21 (0-7 = normal, 8-10 = borderline, 11-14 = severe depressive symptoms, >15 very severe depressive symptoms).	7 days, 3 months, 1 year after operation
postoperative pain scores on the numeric rating scale (NRS)	scale	day of operation until 7th postoperative day, 3 months, 1 year after operation
haemoglobin (Anaemia) on a score	Score Hb < 6 g/dl, 6-7.99 g/dl, 8-9.99 g/dl, > 9.99 g/dl	intraoperative
blood loss	estimated blood loss in milliliter	intraoperative

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: June 16, 2014
• First Submitted That Met QC Criteria: February 17, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 24, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Delirium; Cognitive Dysfunction; Postoperative Cognitive Complications
• Other Study ID Numbers: PV4654