Assisted Fluid Management in Patients Undergoing Major Abdominal and Orthopedic Surgery

Goal Directed Fluid Therapy Clinical Trial

— AFM  

Official title:

Manual Versus Assisted Fluid Management in Patients Undergoing Major Abdominal and Orthopedic Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03779373
• Other study ID #: 2018-A03365-50
• Status: Withdrawn
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: July 30, 2020

Study information

• Verified date: May 2019
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare a group of patients managed with a manual GDFT protocol (using the EV1000 monitoring device; Edwards Lifesciences, Irvine, USA) to a group of patients managed using a decision support system for GDFT guidance (implemented on the same EV1000 monitoring) in patients undergoing major abdominal and orthopedic surgery.

Description:

Many trials have indicated that goal-directed fluid therapy (GDFT) strategies may benefit high-risk surgical patients but these strategies are infrequently implemented. It has also been shown that without any goal or protocol for fluid resuscitation, large inter- and intra-provider variability exist and have been correlated with marked variations in patient outcomes. Even under ideal study conditions, strict adherence to GDFT protocols is hampered by the workload and concentration required for consistent implementation.Haemodynamic monitors and protocols alone do not enable optimal fluid titration to be provided consistently to all patients - there must also be appropriate and timely interpretation and intervention.

To address this problem of consistency and protocol adherence, a clinical decision support system, "Assisted Fluid Management" (AFM), has been designed to help ease some of the workload associated with GDFT protocol implementation. The AFM system (released on the European market in March 2017) may help increase GDFT protocol adherence while leaving direction and guidance in the hands of the care providers. This system can suggest fluid bolus administration, analyse the effects of the bolus, and continually re-assess the patient for further fluid requirements.

A recent published study demonstrated that the implementation of the AFM for GDFT guidance resulted in a significantly longer period during surgery with a SVV <13% with a reduced total amount of fluid administered without any difference in postoperative complications. Therefore the goal of this randomized controlled trial is to compare a manual GDFT approach ( standard of care actually in the department) versus an Assisted fluid management approach (using the AFM mode) on the incidence of minor postoperative complications.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 30, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• All adult patients in the operating room scheduled for a major abdominal & orthopedic surgery requiring a cardiac output monitoring (EV1000).

• Written informed consent received before surgery.

Exclusion Criteria:

• Minor Patients.

• No french speaking.

• Atrial fibrillation or severe arythmia.

Related Conditions & MeSH terms

• Goal Directed Fluid Therapy

Intervention

Other:
• Use of a decision support system on the EV1000 monitor (AFM mode)
The way to administer fluid is based on the same monitoring device but will differ by the way fluid is given ( following a manual GDFT protocol versus following recommendation from an active clinical deicsion support system for fluid administration called AFM (assisted fluid management)

Locations

Country	Name	City	State
France	Joosten Alexandre	Paris	Kremlin Bicetre

Sponsors (2)

Lead Sponsor	Collaborator
Erasme University Hospital	APHP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite criteria of minor postoperative complications	This composite score includes 8 items : postoperative nausea and vomiting; delirium and confusion; Infection of surgical site; urinary infection; acute kidney injury (KDIGO I & II classiciation); paralytic ileus; other infection (skin, catheter, unknown etc); Readmission to the hospital within 30 days postoperative	30 days postsurgery
Secondary	Percentage of Time spent during the procedure with a stroke volume variation < 13%	Percentage of Time spent during the procedure with a stroke volume variation < 13%	Postoperative day 1
Secondary	Percentage of Time spent during the procedure with a Cardiac index >2.5l/min/m2	Percentage of Time spent during the procedure with a Cardiac index >2.5l/min/m2	Postoperative day 1
Secondary	composite criteria of major postoperative complications	This composite score includes 14 items : stoma dehiscence; Peritonitis; Sepsis; wound dehiscence; bleeding requiring a redo surgery; pulmonary embolism; pulmonary edema; Pneumonia; acute coronary syndrome; atrial fibrillation; stroke; Dialysis; non scheduled redo surgery; 30days mortality (all causes)	30 days postsurgery
Secondary	cardiac index over the procedure	average cardiac index over the surgery	Postoperative day 1
Secondary	stroke volume over the procedure	average stroke volume over the procedure	Postoperative day 1
Secondary	stroke volume variation over the procedure	average stroke volume variation over the procedure	Postoperative day 1
Secondary	Total Fluid received during the procedure	amount of fluid received during surgery	Postoperative day 1
Secondary	Net fluid balance	Net fluid balance at the end of the ICU stay	Postoperative day 1
Secondary	Postoperative acute care unit or intensive care unit length of stay	Postoperative acute care unit or intensive care unit length of stay	30 days postsurgery
Secondary	Hospital length of stay	hospital length of stay	30 days postsurgery