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

This study has been withdrawn prior to enrollment.
(Logistical problems prior to the recruitment phase.)
Sponsor:
Information provided by (Responsible Party):
Amy Duhachek-Stapelman, MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01225757
First received: July 14, 2010
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Peritoneal Neoplasms
Echocardiography Guided Fluid Management
Device: Echocardiogram

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Fluid administration decrease [ Time Frame: One day (intraoperative period) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Time to extubation [ Time Frame: An average of up to two weeks ] [ Designated as safety issue: No ]
  • Intensive care unit and hospital length of stay [ Time Frame: An average of up to two weeks ] [ Designated as safety issue: No ]
  • Post operative oxygen requirements [ Time Frame: An average of up to two weeks ] [ Designated as safety issue: No ]
  • Cardiac complications [ Time Frame: An average of up to two weeks ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: November 2010
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Echocardiography
These patients will have echocardiography guided fluid management
Device: Echocardiogram
Echocardiography will be utilized during the procedure to guide fluid management.
Other Name: Phillips Echocardiography machines
Active Comparator: Traditional fluid management
Fluid management will be guided by monitoring of central venous pressure and urine output.
Device: Echocardiogram
Echocardiography will be utilized during the procedure to guide fluid management.
Other Name: Phillips Echocardiography machines

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225757

Locations
United States, Nebraska
The Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Amy L Duhachek-Stapelman, MD University of Nebraska
  More Information

No publications provided

Responsible Party: Amy Duhachek-Stapelman, MD, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT01225757     History of Changes
Other Study ID Numbers: 168-10-FB
Study First Received: July 14, 2010
Last Updated: May 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Echocardiography
HIPEC

Additional relevant MeSH terms:
Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases

ClinicalTrials.gov processed this record on August 27, 2014