Know Cancer

or
forgot password

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)


N/A
19 Years
N/A
Not Enrolling
Both
Peritoneal Neoplasms, Echocardiography Guided Fluid Management

Thank you

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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Fluid administration decrease

Outcome Description:

The amount of fluid administered during the intraoperative period will be monitored and recorded. The outcome measure of interest is the difference between fluid given in the standard group vs the echo guided fluid management group.

Outcome Time Frame:

One day (intraoperative period)

Safety Issue:

No

Principal Investigator

Amy L Duhachek-Stapelman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska

Authority:

United States: Institutional Review Board

Study ID:

168-10-FB

NCT ID:

NCT01225757

Start Date:

November 2010

Completion Date:

November 2013

Related Keywords:

  • Peritoneal Neoplasms
  • Echocardiography Guided Fluid Management
  • Echocardiography
  • HIPEC
  • Neoplasms
  • Peritoneal Neoplasms

Name

Location

The Nebraska Medical CenterOmaha, Nebraska  68198