Ignite Creation Date:
2024-05-06 @ 12:30 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03779373
Status:
WITHDRAWN
Last Update Posted:
2019-05-14
First Post:
2018-12-16
Brief Title:
Assisted Fluid Management in Patients Undergoing Major Abdominal and Orthopedic Surgery
Sponsor:
Erasme University Hospital
Organization:
Erasme University Hospital
Study Overview
Official Title:
Manual Versus Assisted Fluid Management in Patients Undergoing Major Abdominal and Orthopedic Surgery A Randomized Controlled Trial
Status:
WITHDRAWN
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Change of hospital when the study will be done We will redo the clinical trial to have the good sponsor for the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AFM
Brief 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
Detailed 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 implementationHaemodynamic 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None