Passive Leg Raise Induced Stroke Volume Changes in Elderly Prior to Elective Surgery Measured by LiDCOplusTM
1 other identifier
interventional
10
1 country
1
Brief 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) .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 22, 2016
CompletedFirst Posted
Study publicly available on registry
November 30, 2016
CompletedDecember 1, 2016
November 1, 2016
1.3 years
November 22, 2016
November 30, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Investigate whether there is an association between a positive response to passive leg raise on stroke volume and post spinal anesthesia.
30 minutes
Study Arms (1)
Passive Leg Raise (PLR)
OTHERThe patient is placed in a 45 degree recumbent position. Stroke volume is measured in ml. Intervention:The patient is placed horizontal and the legs are passively raised to 45 degrees. Measurement:The effect of the PLR on Stroke Volume is measured. Thereafter the patient is repositioned to the initial position and Stroke Volume is measured again.
Interventions
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.
Eligibility Criteria
You may qualify if:
- patients ≥80 years of age, undergoing elective urologic surgical procedure
You may not qualify if:
- age \<80 years, severe aortic insufficiency, first case of the day on the operation program, unavailability of research personnel and contraindication to Lithium.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karolinska University Hospital
Huddinge, 14186, Sweden
Study Officials
- PRINCIPAL INVESTIGATOR
Sigridur Kalman, Professor
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 22, 2016
First Posted
November 30, 2016
Study Start
October 1, 2013
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
December 1, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share