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Autonomic Cardiovascular Control for Elderly Surgery Patients

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ClinicalTrials.gov Identifier: NCT01698125
Recruitment Status : Terminated (Practical circumstances made it too difficult to carry out as planned.)
First Posted : October 2, 2012
Last Update Posted : April 15, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Delirium 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 Design

Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Autonomic Cardiovascular Control for Elderly Surgery Patients
Study Start Date : October 2012
Primary Completion Date : November 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Change in orthostatic cardiovascular responses [ Time Frame: 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 :
  1. Barthel Activities of Daily Living (ADL) Scale [ Time Frame: Baseline ]
    Score from 0-20 points

  2. Nottingham Extended Activity of Daily Living (NEADL) Scale [ Time Frame: Baseline ]
    Score from 0-66 points.

  3. Cumulative Illness Rating Scale [ Time Frame: Baseline ]
    Total score from 0-56.

  4. Dementia [ Time Frame: 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.

  5. Delirium [ Time Frame: 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.

  6. Cortisol [ Time Frame: 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.

  7. Severity of delirium [ Time Frame: 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.

  8. Gait speed [ Time Frame: Baseline ]
    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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698125


Locations
Norway
Oslo University Hospital, Ullevaal
Oslo, Norway
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

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01698125     History of Changes
Other Study ID Numbers: 2011/2498/REK nord
First Posted: October 2, 2012    Key Record Dates
Last Update Posted: April 15, 2014
Last Verified: April 2014

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
Neurocognitive Disorders
Mental Disorders