Autonomic Cardiovascular Control for Elderly Surgery Patients

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.

Study Overview

• Status: Terminated
• Conditions: Delirium
• Intervention / Treatment: Procedure: Abdominal surgery

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.

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital, Ullevaal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for abdominal surgery at Oslo University Hospital.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Abdominal surgery; Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital	Procedure: Abdominal surgery; Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in orthostatic cardiovascular responses	Change in orthostatic cardiovascular responses (head-up tilt test) pre- and postoperatively in patients with and without postoperative delirium will be evaluated based on measurements of heart rate, systolic blood pressure (BP), mean BP, diastolic BP, stroke index, total peripheral resistance index, end-diastolic volume index, and acceleration index.	Baseline and postoperatively at surgical ward (expected second postoperative day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barthel Activities of Daily Living (ADL) Scale	Score from 0-20 points	Baseline
Nottingham Extended Activity of Daily Living (NEADL) Scale	Score from 0-66 points.	Baseline
Cumulative Illness Rating Scale	Total score from 0-56.	Baseline
Dementia	Simple cognitive tests preformed preoperatively, including MMSE, Clock Drawing Test, Trail making A and B and Ten word memory test. Also IQCODE when reliable information is present.	Baseline
Delirium	Daily assessing the patient using the Confusion Assessment Method (CAM), shortened version.	Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days.
Cortisol	Looking for differences in levels of cortisol in saliva (morning samples) pre-and postoperatively in patients developing delirium compared to patients not developing delirium.	Baseline and second postoperative day
Severity of delirium	Daily assessing the patient using MDAS (the memorial delirium assessment scale). Total score from 0-30.	Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days
Gait speed	Measuring comfortable gait speed at length of 4 meters, best result of 2 tests. Result in meter per second.	Baseline

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: South-Eastern Norway Regional Health Authority
• Investigators: Study Director: Torgeir B Wyller, MD, Prof, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: September 27, 2012
• First Submitted That Met QC Criteria: September 28, 2012
• First Posted (Estimate): October 2, 2012

Study Record Updates

• Last Update Posted (Estimate): April 15, 2014
• Last Update Submitted That Met QC Criteria: April 14, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Delirium; Abdominal surgery; Autonomic cardiovascular control; Tilt-test
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: 2011/2498/REK nord