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Abdominal Aortic Aneurysm UncomplicatedPhase 1NCT01681251

Goal Directed Therapy for Patients Undergoing Major Vascular Surgery

A Phase 1 study testing Fluid titrated with the use of arterial pulse contour cardiac output monitor if SVV >13% and Fluid titrated at the discretion of the attending anesthesiologist in people with Abdominal Aortic Aneurysm Uncomplicated, run by University of Manitoba at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Abdominal Aortic Aneurysm Uncomplicated
What is being tested?
Fluid titrated with the use of arterial pulse contour cardiac output monitor if SVV >13% and Fluid titrated at the discretion of the attending anesthesiologist
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCanada
Study dates
Aug 2010to Oct 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of Manitoba

    Winnipeg, Manitoba, R3T2N2

Other trials in Canada

About this study

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.

Read the 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.

Being tested
Fluid titrated with the use of arterial pulse contour cardiac output monitor if SVV >13%, Fluid titrated at the discretion of the attending anesthesiologist

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

  • Fluid titrated at the discretion of the attending anesthesiologistOther

    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.

Study groups in NCT01681251
Study groupRoleWhat they receive
InterventionExperimentalFluid titrated with the use of arterial pulse contour cardiac output monitor if SVV >13%
Receives: Other: Fluid titrated with the use of arterial pulse contour cardiac output monitor if SVV >13%
ControlActive comparatorFluid titrated at the discretion of the attending anesthesiologist.
Receives: Other: Fluid titrated at the discretion of the attending anesthesiologist

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Length of Stay

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

    Measured: Up to 180 days.

Secondary outcomes (8)
  1. Total Crystalloid Use

    Measured: 5 days

  2. Total Colloid Use

    Measured: 5 days

  3. Requirement for red blood cell transfusion

    Measured: 7 days

  4. Fluid balance

    Measured: 7 days

  5. Urine output

    Measured: 7 days

  6. Serum creatinine

    Measured: 7 days

  7. Postoperative complications

    Including: myocardial infarction, sepsis, pneumonia, renal failure, bleeding, ICU admission.

    Measured: 28 days

  8. Neutrophil gelatinase associated lipocalnin (NGAL) levels

    Measured: Pre-op, immediately post op, 6 hours post-op and 24 hours post-op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2012 (estimated)
  2. Study startAug 2010
  3. Primary completionJun 2013
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01681251
Sponsor's protocol ID
B2009:135
Status last verified
Nov 2013
First submitted
18 May 2011
Last updated
11 Nov 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 26275521
  • 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.

    PubMed 26062689

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fluid titrated with the use of arterial pulse contour cardiac output monitor if SVV >13% and Fluid titrated at the discretion of the attending anesthesiologist in people with Abdominal Aortic Aneurysm Uncomplicated, run by University of Manitoba at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of Stay (time frame: Up to 180 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01681251, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2013.

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