Through a non-invasive cardiac output measurement we want to investigate in this observational pilot study , if it is possible to reduce the fluid intake in the first 24 hours (both perioperatively and postoperatively) by 30 %
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is a 30% reduction in the amount of fluid administered
during the first 24 hours.
Secondary outcome
Secondary endpoints are differences in the number and type of postoperative
complications, ventilation and ICU and hospital length of stay, inflammatory
response measured by CRP and interleukin values.
Background summary
HIPEC is an operation consisting of a large macroscopic debulking and an
intraperitoneal hyperthermic phase The abdomen is washed with chemotherapy. The
procedure can be complicated by wound healing disorders and risk of seam leaks
after any anastomosis. Two of the components that are potentially involved are
a positive fluid balance and inflammation processes associated with a surgical
response.
Study objective
Through a non-invasive cardiac output measurement we want to investigate in
this observational pilot study , if it is possible to reduce the fluid intake
in the first 24 hours (both perioperatively and postoperatively) by 30 %
Study design
This is an observational pilot study randomized with a total of 40 patients.
Patients are randomized to a liberal policy with intra-arterial blood pressure,
fluid and central venous pressure measurement and a restrictive policy with the
same moisture monitoring. In the restrictive group, the arterial and central
venous line are connected to the Flowtrac / Vigileo for non invasive cardiac
output measurement. We also measure the inflammatory response through blood
tests to determine interleukins.
Study burden and risks
To non-invasive cardiac output monitoring are no additional risks than the
risks already associated with placing a central venous line and arterial line.
The advantage to longer term are shorter hospital stay in the ICU and a lower
risk of wound healing problems or seam leaks.
Koekoekslaan 1
3430 EM Nieuwegein
NL
Koekoekslaan 1
3430 EM Nieuwegein
NL
Listed location countries
Age
Inclusion criteria
patients 18 years and older who require HIPEC procedures
Exclusion criteria
LVEF <40%
preoperative arrythmia
severe coronary artery disease
no epidural analgesia
termination of HIPEC procedure
use of preoperative diuretics.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL37666.100.11 |