Autonomic Cardiovascular Control for Elderly Surgery Patients

This study has been terminated.
(Practical circumstances made it too difficult to carry out as planned.)
Sponsor:
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: April 14, 2014
Last verified: April 2014
  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.


Enrollment: 3
Study Start Date: October 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: April 14, 2014
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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014