Goal Directed Therapy for Patients Undergoing Major Vascular Surgery
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|ClinicalTrials.gov Identifier: NCT01681251|
Recruitment Status : Completed
First Posted : September 7, 2012
Last Update Posted : November 11, 2013
The management and delivery of intravenous fluids during surgical operations is one of the important duties for anesthesiologists.
The goal of this study was to determine if goal directed fluid therapy, titrated using the FloTrac monitor's measurement of stroke volume variation results in a decrease in the length of stay of patients undergoing open abdominal aneurysm repair.
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Aortic Aneurysm Uncomplicated||Other: Fluid titrated with the use of arterial pulse contour cardiac output monitor if SVV >13% Other: Fluid titrated at the discretion of the attending anesthesiologist||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Goal Directed Therapy for Patients Undergoing Major Vascular Surgery|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||October 2013|
Fluid titrated with the use of arterial pulse contour cardiac output monitor if SVV >13%
Other: Fluid titrated with the use of arterial pulse contour cardiac output monitor if SVV >13%
Following induction of anesthesia, Voluven boluses of 250ml will be given if SVV increases above 10%. Further Voluven boluses will be given in 250ml aliquots should the SVV increase to greater than 10%. If a total of 55ml/kg of Voluven is given, the fluid will be changed to lactated ringers and no further colloid will be given, as this is the maximum dose recommend by the manufacturer.
Vasoactive agents (type and dose at the discretion of the attending anesthesiologist) may be given to maintain a mean arterial pressure that the clinical team feels adequate to maintain adequate organ perfusion. In the intervention group, however, vasoactive agents will not be given unless fluid administration has resulted in a maximal value of SV.
Active Comparator: Control
Fluid titrated at the discretion of the attending anesthesiologist.
Other: Fluid titrated at the discretion of the attending anesthesiologist
In the control group, the data from the FloTrac monitor will not be available to the anesthesia care provider. Fluid replacement will be at a rate and of a type that is entirely up to the anesthesiologist; the only stipulation being that Voluven is to be used should the provider desire to use a colloid solution.
- Length of Stay [ Time Frame: Up to 180 days. ]Patients will be assessed for fitness for hospital discharge. This will be used to calculate the length of stay.
- Total Crystalloid Use [ Time Frame: 5 days ]
- Total Colloid Use [ Time Frame: 5 days ]
- Requirement for red blood cell transfusion [ Time Frame: 7 days ]
- Fluid balance [ Time Frame: 7 days ]
- Urine output [ Time Frame: 7 days ]
- Serum creatinine [ Time Frame: 7 days ]
- Postoperative complications [ Time Frame: 28 days ]Including: myocardial infarction, sepsis, pneumonia, renal failure, bleeding, ICU admission.
- Neutrophil gelatinase associated lipocalnin (NGAL) levels [ Time Frame: Pre-op, immediately post op, 6 hours post-op and 24 hours post-op ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681251
|University of Manitoba|
|Winnipeg, Manitoba, Canada, R3T2N2|
|Principal Investigator:||Duane J Funk, MD||University of Manitoba|