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Goal Directed Therapy for Patients Undergoing Major Vascular Surgery

Primary Purpose

Abdominal Aortic Aneurysm Uncomplicated

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Fluid titrated with the use of arterial pulse contour cardiac output monitor if SVV >13%
Fluid titrated at the discretion of the attending anesthesiologist
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm Uncomplicated

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists physical class I-III patients over the age of 18 years
  • Presenting for elective open repair of abdominal aortic aneurysms.

Exclusion Criteria:

  • Weight >120kg
  • Known or suspected valvular aortic insufficiency
  • Renal Dysfunction (serum creatinine >150 μmol/l)
  • Pre-existing bowel dysfunction
  • Active congestive heart failure

Sites / Locations

  • University of Manitoba

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Fluid titrated with the use of arterial pulse contour cardiac output monitor if SVV >13%

Fluid titrated at the discretion of the attending anesthesiologist.

Outcomes

Primary Outcome Measures

Length of Stay
Patients will be assessed for fitness for hospital discharge. This will be used to calculate the length of stay.

Secondary Outcome Measures

Total Crystalloid Use
Total Colloid Use
Requirement for red blood cell transfusion
Fluid balance
Urine output
Serum creatinine
Postoperative complications
Including: myocardial infarction, sepsis, pneumonia, renal failure, bleeding, ICU admission.
Neutrophil gelatinase associated lipocalnin (NGAL) levels

Full Information

First Posted
May 18, 2011
Last Updated
November 7, 2013
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT01681251
Brief Title
Goal Directed Therapy for Patients Undergoing Major Vascular Surgery
Official Title
Goal Directed Therapy for Patients Undergoing Major Vascular Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
The management and delivery of intravenous fluids during surgical operations is one of the important duties for anesthesiologists. There is a growing body of evidence that fluid overload in surgical patients is associated with decreased wound healing, slower return of gut function, anastomotic breakdown, pulmonary edema and post-operative visual changes. In the United States, abdominal aortic aneurysms are diagnosed in 190,000 people per year, and over 50,000 of those have the aneurysm repaired5. Recent advances in endovascular techniques have allowed many of these patients to forego an open repair. However, because of technical difficulties, many patients still require an open repair. The most common cause of morbidity in these patients is related to post-operative gastrointestinal tract dysfunction. This usually involves an adynamic ileus that the patients develop on the fourth post-operative day. This delays their tolerance of enteral foods and lengthens their hospital stay and hospital costs. It also has the potential of causing more morbidity in that patients may require total parenteral nutrition while awaiting return of bowel function. There are several causes of this gastrointestinal morbidity including direct mechanical trauma to the bowel during surgery and activation of the inflammatory cascade. These factors are unfortunately not modifiable by the team caring for the patient. One factor that is modifiable is the amount and type of intravenous fluids administered to the patient. Typically, anesthesiologists decide on the amount of fluid to administer to patients based on parameters such as heart rate, blood pressure and urine output. These are unfortunately unreliable in determining a patient's volume status, as these parameters can be within the normal range, and a patient might still have inadequate perfusion to their vital organs. Further, clinician's reliance on blood pressure as a target for fluid administration ignores the fact that organs require blood flow as well as pressure to function optimally. Until recently, the only way to measure blood flow was with the insertion of a pulmonary artery catheter. Based on several studies showing a lack of benefit of this invasive procedure, it has fallen out of favor in the non-cardiac arena. Newer monitors of cardiac output that can be attached to a patients arterial catheter (commonly placed for major surgical procedures) offer an alternative method for clinicians to measure cardiac output. One of these monitors, the FloTrac system (Edwards Life Sciences, Irvine CA), utilizes the arterial pulse contour to calculate cardiac output (CO) and the stroke volume variation (SVV) as a monitor of volume status. In patients who are mechanically ventilated there is a phasic variation in CO and stroke volume based on the ventilatory cycle. Large changes in stroke volume during the ventilatory cycle may indicate hypovolemia in patients. The administration of intravenous fluid to these patients results in a decrease in the SVV. Thus, the SVV can be use a volume monitor and used to titrate intravenous therapy. There have been several trials (mostly in colonic resection surgery) that have looked at such goal directed therapy with this and similar devices and have found a decrease in patient morbidity and length of stay. All of these studies have in common the use of a minimally invasive CO monitor and a reliance on colloids as the predominant fluid utilized during the case. The utilization of SVV to determine volume status is a novel approach to fluid management in surgical patients. As stated above, clinicians' historical reliance on pressures (such as as blood pressure and central venous pressure) to estimate intravascular volume status is based on an incomplete understanding on the factors that govern organ blood flow. To this end, the investigators will also assess several parameters during this study in an attempt to ascertain which is the best at predicting fluid responsiveness. Fluid responsiveness is defined as the ability to predict if a given patient will increase their CO to a fluid bolus. To date this has not been looked at in a systematic fashion. There is also evidence to suggest that such goal directed therapy reduces the degree of inflammation that invariably occurs after operations of this magnitude. It is hypothesized that by resuscitating the endothelium more effectively with intravenous fluids that remain in the intravascular space longer, there is less endothelial damage and thus less inflammation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm Uncomplicated

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Fluid titrated with the use of arterial pulse contour cardiac output monitor if SVV >13%
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Fluid titrated at the discretion of the attending anesthesiologist.
Intervention Type
Other
Intervention Name(s)
Fluid titrated with the use of arterial pulse contour cardiac output monitor if SVV >13%
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Fluid titrated at the discretion of the attending anesthesiologist
Intervention Description
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.
Primary Outcome Measure Information:
Title
Length of Stay
Description
Patients will be assessed for fitness for hospital discharge. This will be used to calculate the length of stay.
Time Frame
Up to 180 days.
Secondary Outcome Measure Information:
Title
Total Crystalloid Use
Time Frame
5 days
Title
Total Colloid Use
Time Frame
5 days
Title
Requirement for red blood cell transfusion
Time Frame
7 days
Title
Fluid balance
Time Frame
7 days
Title
Urine output
Time Frame
7 days
Title
Serum creatinine
Time Frame
7 days
Title
Postoperative complications
Description
Including: myocardial infarction, sepsis, pneumonia, renal failure, bleeding, ICU admission.
Time Frame
28 days
Title
Neutrophil gelatinase associated lipocalnin (NGAL) levels
Time Frame
Pre-op, immediately post op, 6 hours post-op and 24 hours post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists physical class I-III patients over the age of 18 years Presenting for elective open repair of abdominal aortic aneurysms. Exclusion Criteria: Weight >120kg Known or suspected valvular aortic insufficiency Renal Dysfunction (serum creatinine >150 μmol/l) Pre-existing bowel dysfunction Active congestive heart failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duane J Funk, MD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T2N2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26275521
Citation
Brinkman R, HayGlass KT, Mutch WA, Funk DJ. Acute Kidney Injury in Patients Undergoing Open Abdominal Aortic Aneurysm Repair: A Pilot Observational Trial. J Cardiothorac Vasc Anesth. 2015 Oct;29(5):1212-9. doi: 10.1053/j.jvca.2015.03.027. Epub 2015 Apr 1.
Results Reference
derived
PubMed Identifier
26062689
Citation
Funk DJ, HayGlass KT, Koulack J, Harding G, Boyd A, Brinkman R. A randomized controlled trial on the effects of goal-directed therapy on the inflammatory response open abdominal aortic aneurysm repair. Crit Care. 2015 Jun 10;19(1):247. doi: 10.1186/s13054-015-0974-x.
Results Reference
derived

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Goal Directed Therapy for Patients Undergoing Major Vascular Surgery

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