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Autonomic Cardiovascular Control for Elderly Surgery Patients

Autonomic Cardiovascular Control for Elderly Surgery Patients

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01698125
Enrollment
3
Registered
2012-10-02
Start date
2012-10-31
Completion date
2012-11-30
Last updated
2014-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Keywords

Delirium, Autonomic cardiovascular control, Abdominal surgery, Tilt-test

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.

Interventions

PROCEDUREAbdominal surgery

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

Sponsors

South-Eastern Norway Regional Health Authority
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in orthostatic cardiovascular responsesBaseline 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

MeasureTime frameDescription
Nottingham Extended Activity of Daily Living (NEADL) ScaleBaselineScore from 0-66 points.
Cumulative Illness Rating ScaleBaselineTotal score from 0-56.
DementiaBaselineSimple 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.
Barthel Activities of Daily Living (ADL) ScaleBaselineScore from 0-20 points
CortisolBaseline and second postoperative dayLooking 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 deliriumBaseline and a minimum of 2 days after the second tilt-test, an expected average of 5 daysDaily assessing the patient using MDAS (the memorial delirium assessment scale). Total score from 0-30.
Gait speedBaselineMeasuring comfortable gait speed at length of 4 meters, best result of 2 tests. Result in meter per second.
DeliriumBaseline 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.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026