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

September 27, 2012
April 14, 2014
October 2012
November 2012   (final data collection date for primary outcome measure)
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.
Change in orthostatic cardiovascular responses [ Time Frame: Baseline and 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.
Complete list of historical versions of study NCT01698125 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • Severity of delirium [ Time Frame: Baseline and for the duration of hospital stay, an expected average of 1 week. ] [ Designated as safety issue: No ]
    Using Memorial Delirium Assessment Scale (MDAS), total score from 0-30 points.
  • 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 for the duration of hospital stay, an expected average of 1 week. ] [ 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.
Not Provided
Not Provided
 
Autonomic Cardiovascular Control for Elderly Surgery Patients
Autonomic Cardiovascular Control for Elderly Surgery Patients

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Serum. Plasma. Saliva.

Non-Probability Sample

Patients scheduled for abdominal surgery at Oslo University Hospital.

Delirium
Procedure: Abdominal surgery
Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital
Abdominal surgery
Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital
Intervention: Procedure: Abdominal surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01698125
2011/2498/REK nord
No
Oslo University Hospital
Oslo University Hospital
South-Eastern Norway Regional Health Authority
Study Director: Torgeir B Wyller, MD, Prof Oslo University Hospital
Oslo University Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP