Autonomic Cardiovascular Control for Elderly Surgery Patients

Terminated

• Conditions: Delirium
• Interventions: Procedure: Abdominal surgery

• Registration Number: NCT01698125
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2012-09-27
• Study First Submitted QC: 2012-09-28
• Study Start: 2012-10
• Study First Posted: 2012-10-02
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-14
• Last Update Posted: 2014-04-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Abdominal surgery	Abdominal surgery	Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital

Primary Outcome Measures

Name	Time	Method
Change in orthostatic cardiovascular responses	Baseline and postoperatively at surgical ward (expected second postoperative day)	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.

Secondary Outcome Measures

Name	Time	Method
Cortisol	Baseline and second postoperative day	Looking for differences in levels of cortisol in saliva (morning samples) pre-and postoperatively in patients developing delirium compared to patients not developing delirium.
Severity of delirium	Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days	Daily assessing the patient using MDAS (the memorial delirium assessment scale). Total score from 0-30.
Delirium	Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days.	Daily assessing the patient using the Confusion Assessment Method (CAM), shortened version.
Gait speed	Baseline	Measuring comfortable gait speed at length of 4 meters, best result of 2 tests. Result in meter per second.
Barthel Activities of Daily Living (ADL) Scale	Baseline	Score from 0-20 points
Nottingham Extended Activity of Daily Living (NEADL) Scale	Baseline	Score from 0-66 points.
Cumulative Illness Rating Scale	Baseline	Total score from 0-56.
Dementia	Baseline	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.

Trial Locations

Locations (1)

Oslo University Hospital, Ullevaal; 🇳🇴 Oslo, Norway