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

NCT01225757 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-08-14

No results posted yet for this study

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

Interventions

DEVICE

Echocardiogram

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

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Amy L Duhachek-Stapelman, MD · University of Nebraska

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-08-31
Completion
2011-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01225757 on ClinicalTrials.gov