Autonomic Cardiovascular Control for Elderly Surgery Pati... | NCT01698125

Studies
Autonomic Cardiovascular Control for Elderly Surgery Patients

NCT01698125

Sponsor

Oslo University Hospital

Status

Terminated

Last Update Posted

Apr 15, 2014Estimated

Enrollment

3Actual

Phase

Not provided

Conditions

Delirium

Interventions

Abdominal surgery

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Practical circumstances made it too difficult to carry out as planned.

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Sep 27, 2012

First Submission Date that Met QC Criteria

Sep 28, 2012

First Posted Date

Oct 2, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2014

Last Update Posted Date

Apr 15, 2014Estimated

Name	Class
South-Eastern Norway Regional Health Authority	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Abdominal surgery		Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital	Procedure: Abdominal surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Abdominal surgery	Procedure	Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital	Abdominal surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Barthel Activities of Daily Living (ADL) Scale	Score from 0-20 points	Baseline
Nottingham Extended Activity of Daily Living (NEADL) Scale	Score from 0-66 points.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Patients scheduled for abdominal surgery at Oslo University Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Torgeir B Wyller, MD, Prof	Oslo University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital, Ullevaal		Oslo			Norway

Condition Browse Module

MeSH Terms

ID	Term
D003693	Delirium

Ancestor Terms

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided