NCT02977390

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
Last Updated

December 1, 2016

Status Verified

November 1, 2016

Enrollment Period

1.3 years

First QC Date

November 22, 2016

Last Update Submit

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)

OTHER

The 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.

Other: Passive leg raise

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.

Passive Leg Raise (PLR)

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

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

Location

Study Officials

  • Sigridur Kalman, Professor

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

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

Locations