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Completed

NCT Number: NCT03060174

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

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.

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Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

monitoring and non-medical prophylaxis of delirium

Other

Primary outcomes

  1. postoperative cognitive deficit (POCD)

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

    measured by neuropsychological test battery, analysis

Secondary outcomes

  1. incidence and severity of postoperative delirium

    Time frame: from the day of operation until the 7th postoperative day

    measured 3 times per day via CAM-ICU

  2. number of patients with cardiac complications

    Time frame: day of operation until 7th postoperative day

    daily documentation of cardiac complications (central venous oxygen saturation, myocardial infarction, acute heart failure, others)

  3. length of hospital stay

    Time frame: from day of admission until day of discharge, up to 24 weeks

  4. mortality

    Time frame: 1 year

  5. health related quality of life

    Time frame: 3 months, 1 year after operation

    Short Form Health Survey (SF-12)

  6. number of patients with respiratory complications

    Time frame: day of operation until 7th postoperative day

    daily documentation of pulmonary complications (pneumonia, pulmonary oedema, others),

  7. number of patients with renal complications

    Time frame: day of operation until 7th postoperative day

    daily documentation of renal complications (creatinine, haemo(dia)filtration or haemodialysis)

  8. number of patients with complications in the immunosystem

    Time frame: day of operation until 7th postoperative day

    daily documentation of parameters mirroring the immune answer (C-reactive protein, leukocytes, procalcitonin)

Other outcomes

  1. anxiety and depressive symptoms on HADS-D

    Time frame: 7 days, 3 months, 1 year after operation

    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).

  2. postoperative pain scores on the numeric rating scale (NRS)

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

    scale

  3. haemoglobin (Anaemia) on a score

    Time frame: intraoperative

    Score Hb < 6 g/dl, 6-7.99 g/dl, 8-9.99 g/dl, > 9.99 g/dl

  4. blood loss

    Time frame: intraoperative

    estimated blood loss in milliliter

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Acronym: DelPOCD

Important dates

Study start
2014
Primary completion
2018
Study completion
2021
First posted
Feb 23, 2017
Registry last updated
Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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