NCT03179033

Brief Summary

Left Ventricular Assist Device (LVAD) implantation is a common surgical procedure in patients with end-stage heart failure. Optimal fluid management is essential for adequate postoperative treatment. It is important to identify which patients will benefit from fluid administration. Passive leg raising (PLR) is a validated dynamic method to predict fluid responsiveness in patients with heart failure by inducing a transient increase in cardiac preload. Objective: To investigate the role of PLR on the management of patients following LVAD implantation in the postoperative period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
Last Updated

January 18, 2018

Status Verified

June 1, 2017

Enrollment Period

11 months

First QC Date

June 5, 2017

Last Update Submit

January 17, 2018

Conditions

Keywords

LVADPassive leg raising

Outcome Measures

Primary Outcomes (1)

  • Responsiveness to passive leg raising in patients early after LVAD implantation

    Change in LVAD flow due to passive leg raising

    5 minutes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with heart failure candidate for assist device implantation

You may qualify if:

  • Patients after VAD implantation

You may not qualify if:

  • Age under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba medical center

Ramat Gan, 00000, Israel

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2017

First Posted

June 7, 2017

Study Start

October 19, 2016

Primary Completion

August 30, 2017

Study Completion

August 30, 2017

Last Updated

January 18, 2018

Record last verified: 2017-06

Locations