Hemodynamic Response During Goal Directed Fluid Therapy in the OR

Hemodynamic Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02365688
• Other study ID #: COVMOPR0436
• Status: Terminated
• Phase: N/A
• First received: September 9, 2014
• Last updated: February 15, 2016
• Start date: September 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Electronic and annotated observation data to support an algorithm library

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hemodynamic Instability

Intervention

Procedure:
• Initial bolus pre-incision
Measured hemodynamic response to pre-incision bolus

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic hemodynamic response to fluid resuscitation	Physiological parameters compared before and after fluid bolus for fluid resuscitation. Invasive Blood Pressure (IBP), Stoke volume, cardiac output and other hemodynamic parameters.	12 months	No