Comparison of Traditional and Echocardiography Guided Fluid Management During Cytoreductive Surgery With HIPEC
Primary Purpose
Peritoneal Neoplasms, Echocardiography Guided Fluid Management
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Echocardiogram
Sponsored by
About this trial
This is an interventional diagnostic trial for Peritoneal Neoplasms focused on measuring Echocardiography, HIPEC
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Echocardiography
Traditional fluid management
Arm Description
These patients will have echocardiography guided fluid management
Fluid management will be guided by monitoring of central venous pressure and urine output.
Outcomes
Primary Outcome Measures
Fluid administration decrease
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
The amount of time for participants to be extubated
Intensive care unit and hospital length of stay
Duration of stay in intensive care and overall time in hospital
Post operative oxygen requirements
The need, level and duration of any required post-operative oxygen
Cardiac complications
Post operative cardiac complications including tachyarrhythmias, heart failure and pulmonary edema
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01225757
Brief Title
Comparison of Traditional and Echocardiography Guided Fluid Management During Cytoreductive Surgery With HIPEC
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Logistical problems prior to the recruitment phase
Study Start Date
November 2010 (Anticipated)
Primary Completion Date
August 31, 2011 (Actual)
Study Completion Date
August 31, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Neoplasms, Echocardiography Guided Fluid Management
Keywords
Echocardiography, HIPEC
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Echocardiography
Arm Type
Experimental
Arm Description
These patients will have echocardiography guided fluid management
Arm Title
Traditional fluid management
Arm Type
Active Comparator
Arm Description
Fluid management will be guided by monitoring of central venous pressure and urine output.
Intervention Type
Device
Intervention Name(s)
Echocardiogram
Other Intervention Name(s)
Phillips Echocardiography machines
Intervention Description
Echocardiography will be utilized during the procedure to guide fluid management.
Primary Outcome Measure Information:
Title
Fluid administration decrease
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.
Time Frame
One day (intraoperative period)
Secondary Outcome Measure Information:
Title
Time to extubation
Description
The amount of time for participants to be extubated
Time Frame
An average of up to two weeks
Title
Intensive care unit and hospital length of stay
Description
Duration of stay in intensive care and overall time in hospital
Time Frame
An average of up to two weeks
Title
Post operative oxygen requirements
Description
The need, level and duration of any required post-operative oxygen
Time Frame
An average of up to two weeks
Title
Cardiac complications
Description
Post operative cardiac complications including tachyarrhythmias, heart failure and pulmonary edema
Time Frame
An average of up to two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy L Duhachek-Stapelman, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Comparison of Traditional and Echocardiography Guided Fluid Management During Cytoreductive Surgery With HIPEC
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