Autonomic Cardiovascular Control for Elderly Surgery Patients

NCT ID: NCT01698125

Last Updated: 2014-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Abdominal surgery

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

Abdominal surgery

Intervention Type PROCEDURE

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

Interventions

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Abdominal surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South-Eastern Norway Regional Health Authority

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Torgeir B Wyller, MD, Prof

Role: STUDY_DIRECTOR

Oslo University Hospital

Locations

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Oslo University Hospital, Ullevaal

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2011/2498/REK nord

Identifier Type: -

Identifier Source: org_study_id

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