Impact of Fluid and Passive Leg Raising on Cardiac Output... | NCT03179033

Studies
Impact of Fluid and Passive Leg Raising on Cardiac Output in Patients Undergoing Cardiac Surgery

NCT03179033

Sponsor

Sheba Medical Center

Status

Completed

Last Update Posted

Jan 18, 2018Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Artificial Heart Device User

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 19, 2016Actual

Primary Completion Date

Aug 30, 2017Actual

Completion Date

Aug 30, 2017Actual

First Submitted Date

Jun 5, 2017

First Submission Date that Met QC Criteria

Jun 5, 2017

First Posted Date

Jun 7, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2018

Last Update Posted Date

Jan 18, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Responsiveness to passive leg raising in patients early after LVAD implantation	Change in LVAD flow due to passive leg raising	5 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients after VAD implantation

Exclusion Criteria:

Age under 18

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with heart failure candidate for assist device implantation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba medical center		Ramat Gan		00000	Israel