Performance of Non-Invasive Monitors During ANH | NCT02179827

Studies
Performance of Non-Invasive Monitors During ANH

NCT02179827

Sponsor

University of California, Davis

Status

Withdrawn

Last Update Posted

Apr 27, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Baseline
Hemodilution

Interventions

Not provided

Countries

United States

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

Apr 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study never commenced, and is now closed.

Expanded Access Info

Start Date

Nov 2022Estimated

Primary Completion Date

Nov 2023Estimated

Completion Date

Nov 2024Estimated

First Submitted Date

Mar 11, 2014

First Submission Date that Met QC Criteria

Jun 30, 2014

First Posted Date

Jul 2, 2014Estimated

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

Apr 26, 2022

Last Update Posted Date

Apr 27, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The aim of this study is to assess the responsiveness of the standard minimally invasive hemodynamic monitors used in the operating room to known changes in the intravascular volume status that occur during blood removal and volume replacement with three different standard fluids used during ANH.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in cardiac output	Metrics: Cardiac output stroke volume Stroke volume: variation	Baseline (Supine) Volume Replaced (S/P ANH)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Those surgical procedures where ANH is included in the surgical plan and consent is obtained

Exclusion Criteria:

Severe or symptomatic COPD, emphysema, renal, hepatic or coronary artery disease as defined by the American College of Cardiology (Cannon et al., 2001).
Esophageal pathology (diverticulum, hiatal hernia, esophageal cancer, esophageal surgery), which introduces risks associated with the placement of the esophageal Doppler.
Ascites.
BMI >35
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients scheduled for elective procedures requiring normovolemic hemodilution

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UC Davis Health System		Sacramento	California	95832	United States