Cancer Clinical Trial
Official title:
Use of an Advanced Minimally Invasive Hemodynamic Monitoring for Perioperative Fluid Management in Hepatobiliary and Pancreas Surgery: A Pilot Study
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 |
Verified date | July 2018 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Carolinas Medical Center | Charlotte | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
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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