Hemodynamic Response During Goal Directed Fluid Therapy in the OR

NCT ID: NCT02365688

Last Updated: 2017-07-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-06-30

Brief Summary

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The purpose of this study is to retrospectively evaluate the hemodynamic response to goal directed fluid therapy fluid during open abdominal surgery where goal directed fluid therapy is a standard of care after establishing a pre-incision baseline response to fluids.

Detailed Description

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Electronic and annotated observation data to support an algorithm library

Conditions

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Hemodynamic Instability

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Initial bolus pre-incision

Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded

Group Type OTHER

Initial bolus pre-incision

Intervention Type PROCEDURE

Measured hemodynamic response to pre-incision bolus

Interventions

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Initial bolus pre-incision

Measured hemodynamic response to pre-incision bolus

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Adults ≥18 years booked for an open abdominal procedure
2. American Society of Anaesthesiologists (ASA) Physical Status 1 - 3
3. Expected duration of surgical procedure to be ≥ 2 hours
4. Standard of care monitoring to include cardiac output

Exclusion Criteria

1. Open chest surgical procedure expected
2. Cardiac arrhythmia such as atrial fibrillation.
3. Right Ventricular Failure
4. Aortic regurgitation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic - MITG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy E Miller, MB ChB, FRCA

Role: PRINCIPAL_INVESTIGATOR

DUHS Department of Anestheiology

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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COVMOPR0436

Identifier Type: -

Identifier Source: org_study_id

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