Ignite Creation Date:
2024-05-05 @ 9:20 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00869297
Status:
COMPLETED
Last Update Posted:
2011-04-19
First Post:
2009-03-24
Brief Title:
Goal Directed Fluid Therapy in Free Flap Patients
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
Goal Directed Fluid Therapy for Microvascular Free Flap Reconstruction Following Mastectomy A Pilot Study
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fluid management of surgical patients has changed dramatically in recent years Recent studies have shown that so called restrictive fluid strategies can improve outcomes such as length of stay and time to fitness for discharge Furthermore new monitoring technologies have been developed that allow the clinician to better monitor the effects of intravenous fluid therapy
The fluid management of free flap reconstruction surgery is controversial As vasoactive agent use during the anesthetic is not the preferred intervention for the treatment of hypotension fluid therapy is often administered to correct hemodynamic instability A liberal fluid strategy may predispose the flap to edema venous congestion and ultimately flap failure A restrictive fluid strategy however has at this institution anecdotally been reported to lead to a higher incidence of deep venous thrombosis DVT and pulmonary embolus PE Thus there is clinical equipoise as to the optimal fluid management for these patients
Non-invasive cardiac output CO monitoring based on the arterial pulse contour is a nascent technological advance that has been widely validated in the operating theatre The calculation of CO is based on the assumption that stroke volume is proportional to the integral of the area under the arterial pressure versus time curve With these monitors the variation in stroke volume during mechanical ventilation is also calculated and this can be utilized as an estimate of the patients volume status A stroke volume variation SVV of less than 15 has been shown to be indicative that a patient is no longer volume responsive
In our study we plan to recruit patients undergoing microvascular free flap reconstruction Patients will be randomized to either standard care or goal directed fluid therapy
All patients will receive a pre-operative 5 ml kg-1 bolus of normal saline Subsequently all patients will then receive lactated ringers at a rate of 5 ml kg-1 hr-1 Patients in the intervention group will have their CO and SVV monitored by a Flo-Trac pulse contour monitor Edwards Life Sciences Irvine CA Patients in the intervention group will receive 6 tetrastarch boluses Voluven Fresenius Kabi Hamburg Germany if their SVV exceeds 15 Patients in the control arm will receive fluid at a rate and type at the discretion of the attending anesthesiologist to maintain hemodynamic stability and a urine output of 05 ml kg-1 hr-1
Intra-operative variables studied will include total fluid administered colloid and crystalloid urine output SVV and CO both at the start and end of surgery Postoperative variables examined will be urine output daily fluid balance days 0-3 incidence of DVT PE pulmonary edema rate of re-operation daily serum creatinine chloride and bicarbonate concentration and incidence of flap failure
Measurements of flap oxygenation and water content will be made with near infrared spectroscopy at baseline and during the immediate post-operative period days 1-7
We hypothesize that the goal directed group would have more intra-operative colloid given with a reduced incidence of adverse outcomes
The fluid management of free flap reconstruction surgery is controversial As vasoactive agent use during the anesthetic is not the preferred intervention for the treatment of hypotension fluid therapy is often administered to correct hemodynamic instability A liberal fluid strategy may predispose the flap to edema venous congestion and ultimately flap failure A restrictive fluid strategy however has at this institution anecdotally been reported to lead to a higher incidence of deep venous thrombosis DVT and pulmonary embolus PE Thus there is clinical equipoise as to the optimal fluid management for these patients
Non-invasive cardiac output CO monitoring based on the arterial pulse contour is a nascent technological advance that has been widely validated in the operating theatre The calculation of CO is based on the assumption that stroke volume is proportional to the integral of the area under the arterial pressure versus time curve With these monitors the variation in stroke volume during mechanical ventilation is also calculated and this can be utilized as an estimate of the patients volume status A stroke volume variation SVV of less than 15 has been shown to be indicative that a patient is no longer volume responsive
In our study we plan to recruit patients undergoing microvascular free flap reconstruction Patients will be randomized to either standard care or goal directed fluid therapy
All patients will receive a pre-operative 5 ml kg-1 bolus of normal saline Subsequently all patients will then receive lactated ringers at a rate of 5 ml kg-1 hr-1 Patients in the intervention group will have their CO and SVV monitored by a Flo-Trac pulse contour monitor Edwards Life Sciences Irvine CA Patients in the intervention group will receive 6 tetrastarch boluses Voluven Fresenius Kabi Hamburg Germany if their SVV exceeds 15 Patients in the control arm will receive fluid at a rate and type at the discretion of the attending anesthesiologist to maintain hemodynamic stability and a urine output of 05 ml kg-1 hr-1
Intra-operative variables studied will include total fluid administered colloid and crystalloid urine output SVV and CO both at the start and end of surgery Postoperative variables examined will be urine output daily fluid balance days 0-3 incidence of DVT PE pulmonary edema rate of re-operation daily serum creatinine chloride and bicarbonate concentration and incidence of flap failure
Measurements of flap oxygenation and water content will be made with near infrared spectroscopy at baseline and during the immediate post-operative period days 1-7
We hypothesize that the goal directed group would have more intra-operative colloid given with a reduced incidence of adverse outcomes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None