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

Postoperative Delirium Clinical Trial

— DelPOCD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03060174
• Other study ID #: PV4654
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: May 2021

Study information

• Verified date: October 2021
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 638
• Est. completion date: May 2021
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Delirium
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction
• Postoperative Delirium

Intervention

Other:
• monitoring and non-medical prophylaxis of delirium

Locations

Country	Name	City	State
Germany	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

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	postoperative pain scores on the numeric rating scale (NRS)	scale	day of operation until 7th postoperative day, 3 months, 1 year after operation
Other	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
Other	blood loss	estimated blood loss in milliliter	intraoperative
Primary	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	incidence and severity of postoperative delirium	measured 3 times per day via CAM-ICU	from the day of operation until the 7th postoperative day
Secondary	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
Secondary	length of hospital stay		from day of admission until day of discharge, up to 24 weeks
Secondary	mortality		1 year
Secondary	health related quality of life	Short Form Health Survey (SF-12)	3 months, 1 year after operation
Secondary	number of patients with respiratory complications	daily documentation of pulmonary complications (pneumonia, pulmonary oedema, others),	day of operation until 7th postoperative day
Secondary	number of patients with renal complications	daily documentation of renal complications (creatinine, haemo(dia)filtration or haemodialysis)	day of operation until 7th postoperative day
Secondary	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