Trial Information

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 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.