Passive Leg Raise Induced Stroke Volume Changes in Elderly Prior to Elective Surgery Measured by LiDCOplusTM

Fluid Therapy Clinical Trial

Official title:

Passive Leg Raise Induced Stroke Volume Changes in Elderly Prior to Elective Surgery Measured by LiDCOplusTM to Guide Fluid Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02977390
• Other study ID #: ANE-HS 2013-06
• Status: Completed
• Phase: N/A
• First received: November 22, 2016
• Last updated: November 30, 2016
• Start date: October 2013
• Est. completion date: January 2015

Study information

• Verified date: November 2016
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

This is a pilot study to investigate whether patients at advanced age are fluid responders via a reversible fluid challenge, the passive leg raise test. This will be measured with a non-invasive cardiac output monitor, the LiDCO (LiDCO Hemodynamic monitoring) .

Description:

The intervention is as simple as a passive leg raise with measurement of effect on Stroke volume.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 80 Years and older

Eligibility

Inclusion Criteria:

• patients =80 years of age, undergoing elective urologic surgical procedure

Exclusion Criteria:

• age <80 years, severe aortic insufficiency, first case of the day on the operation program, unavailability of research personnel and contraindication to Lithium.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cardiovascular System
• Fluid Therapy
• Stroke
• Stroke Volume

Intervention

Other:
• Passive leg raise
By tilting the patient's bed from sitting 45 degrees to supine with legs tilted up 45 degrees we recruit the blood volume in the legs and can measure a reversible fluid challenge on stroke volume.

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Huddinge

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess passive leg raise responsiveness in spontaneously breathing aged patients.	Stroke volume changes in ml and as per cent change compared to baseline	Within 1 minute of the intervention	No
Secondary	Investigate whether there is an association between a positive response to passive leg raise on stroke volume and post spinal anesthesia.	Post spinal bloodpressure per cent change or 30 mmHg decrease	30 minutes	No