Clinical trial NCT01698125: Autonomic Cardiovascular Control for Elderly Surgery Patients
Official title: Autonomic Cardiovascular Control for Elderly Surgery Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Delirium
Keywords: Delirium
Autonomic cardiovascular control
Abdominal surgery
Tilt-test
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
First posted: 2012-10-02
Enrollment: 3
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for abdominal surgery at Oslo University Hospital.

Brief summary: The purpose of this study is to study aspects of autonomic cardiovascular control and the level of stress hormones and inflammatory markers in saliva or serum, in elderly patients exposed to elective, major abdominal surgery, with or without postoperative delirium, to explore the hypothesis that delirium may be the result of aberrant stress responses.

Detailed description: Patients admitted for elective, major, abdominal surgery will be tested with a head-up tilting to 20 degrees for 15 minutes preoperatively and again on the second postoperative day. Haemodynamic variables will be registered by the device TaskForceMonitor which monitors heart rate (HR), electrocardiography (ECG), blood pressure and stroke volume continuously and non-invasively.

Background variables (including demographics, comorbidity and simple cognitive tests) and daily variables (including delirium assessments) will be registered.

Blood and saliva samples will be drawn preoperatively and postoperatively to measure levels of stress hormones and inflammatory markers.

Eligibility criteria: Inclusion Criteria:

* Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital

Exclusion Criteria:

* Absence of a valid informed consent or assent, or consent from a legal proxy
* Patients with atrial fibrillation or a pacemaker rhythm
* Polyneuropathy
* Current treatment with beta-blockers, calcium-blockers or cholinesterase inhibitors
* Competing research project

Primary outcomes:
measure: Change in orthostatic cardiovascular responses
timeFrame: Baseline and postoperatively at surgical ward (expected second postoperative day)
Secondary outcomes:
measure: Barthel Activities of Daily Living (ADL) Scale
timeFrame: Baseline
measure: Nottingham Extended Activity of Daily Living (NEADL) Scale
timeFrame: Baseline
measure: Cumulative Illness Rating Scale
timeFrame: Baseline
measure: Dementia
timeFrame: Baseline
measure: Delirium
timeFrame: Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days.
measure: Cortisol
timeFrame: Baseline and second postoperative day
measure: Severity of delirium
timeFrame: Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days
measure: Gait speed
timeFrame: Baseline
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Ullevaal
Study officials:
affiliation: Oslo University Hospital
name: Torgeir B Wyller, MD, Prof
role: STUDY_DIRECTOR
References: