Comparison of Traditional and Echocardiography Guided Fluid Management During Cytoreductive Surgery With HIPEC



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:19 - Any
Updated:5/5/2014
Start Date:November 2010
End Date:November 2013

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Comparison of Traditional (Central Venous Pressure (CVP) and Urine Output Guided) Versus Echocardiography Guided Fluid Management in Patients Undergoing Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) is performed in
patients with peritoneal tumors. Classically, this procedure is prolonged in duration and
involves significant fluid shifts. Patients receive a large amount of volume replacement
during this procedure (between 10 and 20 liters). The traditional methods to monitor
adequacy of volume replacement are measurement of urine output and central venous pressure.
There are drawbacks of any method of intravascular volume status measurement which may lead
to over or under replacement of fluids. If fluid replacement is underestimated, the patient
may suffer from adverse effects such as hypotension and renal dysfunction. However, the
excessive administration of fluids may lead to other adverse events, including cardiac
dysrhythmias and heart failure. The hypothesis of this study is that patients in whom
volume status is maintained by utilizing a transesophageal echocardiogram will have better
maintenance of fluid status while avoiding intravascular volume overload.

Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) is a procedure
in which peritoneal surface tumors are removed followed by infusion of a heated
chemotherapeutic solution into the abdominal cavity. This procedure is typically 6-10 hours
in duration and is accompanied by significant fluid shifts and hemodynamic changes.
Patients frequently receive between 10 and 20 liters of fluid during the procedure. Patients
undergoing cytoreductive surgery with HIPEC also experience vasodilatation and a
hyperdynamic cardiac state during the hyperthermic period. Classically, the need for volume
replacement has been guided by following a patient's urine output (UOP) and the use of
central venous pressure (CVP). However, several studies have shown that CVP is not a
reliable measure of intravascular fluid status.

We hypothesize that patients undergoing echocardiography guided anesthesia management (EGAM)
will receive significantly less fluid during the operative period when compared to more
traditional fluid therapy guided by monitoring of urine output and central venous pressure.
In addition to the primary endpoint of a decrease in fluid administration, we would predict
a decrease in time to extubation, intensive care unit length of stay, hospital length of
stay, post operative oxygen requirements, post operative complications including
tachyarrhythmias, heart failure and pulmonary edema, and length of time to recovery of bowel
function.

Patients presenting for cytoreductive surgery with HIPEC will be randomized into one of two
groups, the echocardiography guided fluid management group or the traditional CVP/UOP fluid
guided group. For patients in the echocardiography arm, this monitor will be used to
optimize preload, contractility, heart rate and cardiac output. Patients in the CVP/UOP arm
will receive the current standard of fluid administration to maintain adequate urine output.
All patients presenting for the procedure will be offered an opportunity for admission into
the study. Exclusion criteria include any absolute contraindications to transesophageal
echocardiography, including cervical spine instability, esophageal strictures, webs or
rings, patient refusal, esophageal perforation, obstructive esophageal neoplasms (Savage
2004).

A follow-up evaluation will be completed during the remainder of the patient's
hospitalization to evaluate the previously discussed endpoints. The goal is to determine
the optimal fluid management strategy to decrease morbidity in the post-operative period in
patients undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy.

Inclusion Criteria:

- All patients undergoing cytoreductive surgery with hyperthermic intraperitoneal
chemotherapy who are 19 years of age and older will be eligible for inclusion in this
study.

Exclusion Criteria:

- Inability to give informed consent

- Absolute contraindications to transesophageal echocardiography, including cervical
spine instability, esophageal strictures, webs or rings, patient refusal, esophageal
perforation, obstructive esophageal neoplasms.

- Relative contraindications to transesophageal echocardiography esophageal
diverticulum, large hiatal hernias, recent esophageal or gastric surgery, esophageal
varices, history of dysphagia or odynophagia, cervical arthritis, history of
radiation to the mediastinum, deformities of the oral pharynx and severe
coagulopathy.
We found this trial at
1
site
4242 Dewey Ave
Omaha, Nebraska 68105
(800) 922-0000
Nebraska Medical Center Formed in 1997 by combining the operations of University Hospital, Bishop Clarkson...
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mi
from
Omaha, NE
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