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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03612687
Other study ID # 03-14-03E
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2014
Est. completion date November 2014

Study information

Verified date July 2018
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a pilot study with the primary objective to validate the use of advanced minimally invasive hemodynamic monitoring with the PreSep™ Central Venous Oximetry Catheter, the Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management in Hepatobiliary and Pancreas Surgery. All of these devices and monitors are FDA approved devices and routinely used in the perioperative setting for these cases.


Description:

Surgical procedures involving the liver and pancreas are complex and involve paying close attention to hemodynamics to keep the patient stable through the duration of the case. Volume overload in liver and pancreas surgery leads to more intraoperative blood loss and rapid volume shifts make the patient unstable and more difficult to manage. Traditional methods of invasive monitoring to determine cardiac output and stroke volume include the placement of a pulmonary artery catheter and an arterial line. With the addition of the FloTrac™ Sensor to the arterial line and the Vigileo™ monitor; a pulmonary artery catheter would be no longer required. The minimally invasive cardiac output monitor connected to the central venous catheter will generate detailed information of cardiac function and fluid status and thereby help monitor and manage the hemodynamics of the patient intraoperatively. The information obtained from the Vigileo™ will be compared to the regular data normally available in patients undergoing hepatobiliary surgery to determine the advantages of using the system to aid in fluid management of the patient.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 2014
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Adult male and female patients admitted to Carolinas Medical Center (CMC) with the need for the following surgical procedures: liver resection, distal pancreatectomy and splenectomy, and pancreaticoduodenectomy. Exclusion Criteria: 1. Indication for emergency surgery, including pancreatic debridement in an acute setting; ruptured hepatic adenomas/hepatocellular carcinomas 2. Suspected inability to comply with trial procedures or understand consent 3. Employee at the investigational center, relative or spouse of the investigators 4. Patients incarcerated at the time of surgery 5. Females who are pregnant or breastfeeding 6. Planned use of Cell Saver during surgical procedure

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Minimally invasive hemodynamic monitoring
Use of advanced minimally invasive hemodynamic monitoring with PreSep™ Central Venous Oximetry Catheter, Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management

Locations

Country Name City State
United States Carolinas Medical Center Charlotte North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of intraoperative complications Cardiocirculatory, respiratory, neurological, renal, infectious and major bleeding events Intraoperative period
Secondary Extubation time Measurement of time to extubation (hours) up to 48 hours
Secondary Incidence of postoperative blood transfusions Volume of blood transfused following surgical procedure (mL) up to 10 days
Secondary Incidence of postoperative complications Rate of pre-specified postoperative complications (number of patients affected) up to 10 days
Secondary ICU length of stay Intensive Care Unit (ICU) length of stay (days) up to 3 days
Secondary Length of hospital stay Time to discharge from hospital (days) up to 10 days
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