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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Withdrawn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
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Peritoneal Neoplasms focused on measuring Echocardiography, HIPEC

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    July 14, 2010
    Last Updated
    August 9, 2023
    Sponsor
    University of Nebraska
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    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

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

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