Assisted Fluid Management vs Manual GDFT

Surgery Clinical Trial

Official title:

Assisted Versus Manual Goal Directed Fluid Therapy in Major Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141411
• Other study ID #: P2017/234 - B406201731981
• Status: Completed
• Phase: N/A
• First received: May 2, 2017
• Last updated: August 25, 2017
• Start date: May 10, 2017
• Est. completion date: August 24, 2017

Study information

• Verified date: April 2017
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Goal-directed fluid therapy (GDFT) strategies based on cardiac output (CO) optimization have been shown to benefit moderate- to high-risk surgery patients and have recently been recommended by professional societies in the UK, in France, and in Europe. However, despite the growing evidence, these strategies are often not implemented in current practice. One of the reasons for this lack of implementation is that GDFT strategies, like any other complex clinical protocol, require significant provider attention and vigilance for consistent implementation and it is well known that even under study conditions protocol compliance rates are often not greater than 50%. To overpass this problem, our CO monitoring devices (EV1000, Edwards Lifesciences) have now an incorporated assisted fluid management software. This software determines fluid responsiveness by estimating the predicted change in stroke volume and suggests to the anesthesiologist when fluid is required .

Description:

The aim of this study was to assess an assisted fluid management strategy in a moderate-to-high risk surgical cohort and compare that cohort to matched patients who received manual GDFT. Our hypothesis was that the assisted fluid management system would result in higher mean percentage time spent during surgery with a SVV < 13%

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 24, 2017
• Est. primary completion date: August 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients undergoing major abdominal surgery and requiring a CO monitoring for fluid management

Exclusion Criteria:

Emergency surgery Arrhythmia (e.g. atrial fibrillation) Aortic regurgitation

Related Conditions & MeSH terms

• Surgery

Locations

Country	Name	City	State
Belgium	Erasme	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage time spent with SVV < 13%	defined as preload independent state	intraoperative period
Secondary	amount of fluid administered	amount of cristalloid ( baseline ) AND fluid boluses (250 ml) received	intraoperative period
Secondary	amount of vasopressors required	amount of ephedrine, phenylephrine and norepinephrine	intraoperative period
Secondary	fluid balance	FLUID IN - FLUID OUT	intraoperative period
Secondary	incidence of major and minor complications	see study protocol NCT03039946 for the description of these complications	until 30 days post surgery
Secondary	PACU/ICU and hospital length of stay	time spent in ICU and PACU	until 30 days post surgery