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

NCT01225757 | Withdrawn DMC

• 1 other identifier: 0168-10-FB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peritoneal Neoplasms; Echocardiography Guided Fluid Management

Keywords

Echocardiography; HIPEC

Outcome Measures

Primary Outcomes (1)

• 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.

  One day (intraoperative period)

Secondary Outcomes (4)

• Time to extubation

  An average of up to two weeks

• Intensive care unit and hospital length of stay

  An average of up to two weeks

• Post operative oxygen requirements

  An average of up to two weeks

• Cardiac complications

  An average of up to two weeks

Study Arms (2)

Echocardiography

EXPERIMENTAL

These patients will have echocardiography guided fluid management

Device: Echocardiogram

Traditional fluid management

ACTIVE COMPARATOR

Fluid management will be guided by monitoring of central venous pressure and urine output.

Device: Echocardiogram

Interventions

Echocardiogram DEVICE

Echocardiography will be utilized during the procedure to guide fluid management.

Also known as: Phillips Echocardiography machines

Echocardiography; Traditional fluid management

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead

MeSH Terms

Conditions

Peritoneal Neoplasms

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Amy L Duhachek-Stapelman, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: October 21, 2010
• Study Start: November 1, 2010
• Primary Completion: August 31, 2011
• Study Completion: August 31, 2011
• Last Updated: August 14, 2023

Record last verified: 2023-08