Hemodynamic Response During Goal Directed Fluid Therapy in the OR

NCT02365688 | Terminated Results

• 1 other identifier: COVMOPR0436
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemodynamic Instability

Keywords

Open Abdominal Surgical Procedure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Initial bolus pre-incision

OTHER

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

Procedure: Initial bolus pre-incision

Interventions

Initial bolus pre-incision PROCEDURE

Measured hemodynamic response to pre-incision bolus

Initial bolus pre-incision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Open chest surgical procedure expected
• Cardiac arrhythmia such as atrial fibrillation.
• Right Ventricular Failure
• Aortic regurgitation

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Limitations and Caveats

Reference devices did not agree so trial terminated.

Results Point of Contact

• Title: Timothy Miller MB ChB, FRCA
• Organization: Duke University Medical Center, Department of Anesthesiology

timothy.miller2@duke.edu

(+1) 919 6819660

Study Officials

• Timothy E Miller, MB ChB, FRCA

  DUHS Department of Anestheiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: February 19, 2015
• Study Start: September 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 18, 2017
• Results First Posted: May 23, 2016

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)