Hemodynamic Response During Goal Directed Fluid Therapy in the OR

Correlation of Multiple Invasive and Non-Invasive Hemodynamic Monitored Modalities to Support Goal Directed Fluid Therapy During Open Abdominal Surgery

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.

Study Overview

• Status: Terminated
• Conditions: Hemodynamic Instability
• Intervention / Treatment: Procedure: Initial bolus pre-incision

Detailed Description

Electronic and annotated observation data to support an algorithm library

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Initial bolus pre-incision; Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded	Procedure: Initial bolus pre-incision; Measured hemodynamic response to pre-incision bolus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic Hemodynamic Response to Fluid Resuscitation	Physiological parameters compared before and after fluid bolus for fluid resuscitation.	Up to 6 hours but not to exceed duration of surgical procedure

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Timothy E Miller, MB ChB, FRCA, DUHS Department of Anestheiology

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: September 9, 2014
• First Submitted That Met QC Criteria: February 11, 2015
• First Posted (Estimate): February 19, 2015

Study Record Updates

• Last Update Posted (Actual): July 18, 2017
• Last Update Submitted That Met QC Criteria: June 20, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Open Abdominal Surgical Procedure
• Other Study ID Numbers: COVMOPR0436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data collected for new algorithm development