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Trial record 33 of 80731 for:    measured

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

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ClinicalTrials.gov Identifier: NCT02977390
Recruitment Status : Completed
First Posted : November 30, 2016
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Sigridur Kalman, Karolinska Institutet

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) .

Condition or disease Intervention/treatment Phase
Stroke Volume Cardiovascular System Fluid Therapy Other: Passive leg raise Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Passive Leg Raise Induced Stroke Volume Changes in Elderly Prior to Elective Surgery Measured by LiDCOplusTM to Guide Fluid Therapy
Study Start Date : October 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Arm Intervention/treatment
Passive Leg Raise (PLR)

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
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.




Primary Outcome Measures :
  1. Assess passive leg raise responsiveness in spontaneously breathing aged patients. [ Time Frame: Within 1 minute of the intervention ]
    Stroke volume changes in ml and as per cent change compared to baseline


Secondary Outcome Measures :
  1. Investigate whether there is an association between a positive response to passive leg raise on stroke volume and post spinal anesthesia. [ Time Frame: 30 minutes ]
    Post spinal bloodpressure per cent change or 30 mmHg decrease



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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02977390


Locations
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Sweden
Karolinska University Hospital
Huddinge, Sweden, 14186
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Sigridur Kalman, Professor Karolinska Institutet

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Responsible Party: Sigridur Kalman, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02977390     History of Changes
Other Study ID Numbers: ANE-HS 2013-06
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases