Autonomic Cardiovascular Control for Elderly Surgery Patients

Delirium Clinical Trial

Official title:

Autonomic Cardiovascular Control for Elderly Surgery Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01698125
• Other study ID #: 2011/2498/REK nord
• Status: Terminated
• Phase: N/A
• First received: September 27, 2012
• Last updated: April 14, 2014
• Start date: October 2012
• Est. completion date: November 2012

Study information

• Verified date: April 2014
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Committees for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Delirium

Intervention

Procedure:
• Abdominal surgery
Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Ullevaal	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	South-Eastern Norway Regional Health Authority

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Barthel Activities of Daily Living (ADL) Scale	Score from 0-20 points	Baseline	No
Secondary	Nottingham Extended Activity of Daily Living (NEADL) Scale	Score from 0-66 points.	Baseline	No
Secondary	Cumulative Illness Rating Scale	Total score from 0-56.	Baseline	No
Secondary	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	No
Secondary	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.	No
Secondary	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	No
Secondary	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	No
Secondary	Gait speed	Measuring comfortable gait speed at length of 4 meters, best result of 2 tests. Result in meter per second.	Baseline	No