Autonomic Cardiovascular Control for Elderly Surgery Patients
This study is currently recruiting participants.
Verified January 2013 by Oslo University Hospital
Sponsor:
Oslo University Hospital
Collaborator:
South-Eastern Norway Regional Health Authority
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01698125
First received: September 27, 2012
Last updated: January 23, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Delirium |
Procedure: Abdominal surgery |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Autonomic Cardiovascular Control for Elderly Surgery Patients |
Resource links provided by NLM:
Further study details as provided by Oslo University Hospital:
Primary Outcome Measures:
- Change in orthostatic cardiovascular responses [ Time Frame: Baseline and postoperatively at surgical ward (expected second postoperative day) ] [ Designated as safety issue: No ]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:
- Barthel Activities of Daily Living (ADL) Scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]Score from 0-20 points
- Nottingham Extended Activity of Daily Living (NEADL) Scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]Score from 0-66 points.
- Cumulative Illness Rating Scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]Total score from 0-56.
- Dementia [ Time Frame: Baseline ] [ Designated as safety issue: No ]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.
- Delirium [ Time Frame: Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days. ] [ Designated as safety issue: No ]Daily assessing the patient using the Confusion Assessment Method (CAM), shortened version.
- Cortisol [ Time Frame: Baseline and second postoperative day ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days ] [ Designated as safety issue: No ]Daily assessing the patient using MDAS (the memorial delirium assessment scale). Total score from 0-30.
- Gait speed [ Time Frame: Baseline ] [ Designated as safety issue: No ]Measuring comfortable gait speed at length of 4 meters, best result of 2 tests. Result in meter per second.
Biospecimen Retention: Samples With DNA
Serum. Plasma. Saliva.
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2012 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients scheduled for abdominal surgery at Oslo University Hospital.
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698125
Contacts
| Contact: Torgeir B Wyller, MD, Prof. | t.b.wyller@medisin.uio.no | |
| Contact: Karen R Hov, MD | karenroksundhov@gmail.com |
Locations
| Norway | |
| Oslo University Hospital, Ullevaal | Recruiting |
| Oslo, Norway | |
| Contact: Karen R Hov, MD karenroksundhov@gmail.com | |
| Principal Investigator: Karen R Hov, MD | |
Sponsors and Collaborators
Oslo University Hospital
South-Eastern Norway Regional Health Authority
Investigators
| Study Director: | Torgeir B Wyller, MD, Prof | Oslo University Hospital |
More Information
No publications provided
| Responsible Party: | Oslo University Hospital |
| ClinicalTrials.gov Identifier: | NCT01698125 History of Changes |
| Other Study ID Numbers: | 2011/2498/REK nord |
| Study First Received: | September 27, 2012 |
| Last Updated: | January 23, 2013 |
| Health Authority: | Norway: Regional Committees for Medical and Health Research Ethics |
Keywords provided by Oslo University Hospital:
|
Delirium Autonomic cardiovascular control Abdominal surgery Tilt-test |
Additional relevant MeSH terms:
|
Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013