Autonomic Cardiovascular Control for Elderly Surgery Patients

NCT01698125 | Terminated

• 1 other identifier: 2011/2498/REK nord
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in orthostatic cardiovascular responses

  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.

  Baseline and postoperatively at surgical ward (expected second postoperative day)

Secondary Outcomes (8)

• Barthel Activities of Daily Living (ADL) Scale

  Baseline

• Nottingham Extended Activity of Daily Living (NEADL) Scale

  Baseline

• Cumulative Illness Rating Scale

  Baseline

• Dementia

  Baseline

• Delirium

  Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days.

Study Arms (1)

Abdominal surgery

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

Procedure: Abdominal surgery

Interventions

Abdominal surgery PROCEDURE

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

Abdominal surgery

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for abdominal surgery at Oslo University Hospital.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• South-Eastern Norway Regional Health Authority: collaborator

Study Sites (1)

Oslo University Hospital, Ullevaal

Oslo, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum. Plasma. Saliva.

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Torgeir B Wyller, MD, Prof

  Oslo University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2012
• First Posted: October 2, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 15, 2014

Record last verified: 2014-04

Locations

NO (1)