Goal is to use two non-invasive techniques (continuous cardiac output monitoring and impedance measurement) to investigate the possibility of cardiac output measurement and impedance measurement to reduce the fluid intake with 30% reduction while…
ID
Source
Brief title
Condition
- Other condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Health condition
circulatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reducing positive fluid balance 30%. Differences in plasma electrolytes and
differences in measured responses inflammattoire including cytokines and CRP.
Secondary outcome
Secondary endpoints: use of inotropes and diuretics, observation of occurrence
of complications, duration of mechanical ventilation and ICU stay.
Background summary
Previous research has shown that liberal perioperative hydration can lead to an
increase in wound healing disorders and ischemic changes with edema and greater
risk of anastomotic leakage. It is likely that a liberal perioperative fluid
policy also contributes to these postoperative complications.
During HIPEC postoperative inflammatory responses exist induced by the surgery
itself, the surgical trauma and chemical trauma of chemotherapy. This response
is often accompanied by increased fluid requirements. In this study, both the
monitored fluid requirements and administration as well as the inflammatory
response are part of this observational study.
Study objective
Goal is to use two non-invasive techniques (continuous cardiac output
monitoring and impedance measurement) to investigate the possibility of cardiac
output measurement and impedance measurement to reduce the fluid intake with
30% reduction while maintaining normal hemodynamics. The question is whether
this more restrictive fluid policy also affects the inflammatory response.
Study design
In total, 32 patients are included. we will use a web-based program to
randomize betweena policy with standard monitoring and fluid replacements or
with continuous noninvasive cardiac output measurement and impedance
measurement adapted "restrictive" fluid policy.
Study burden and risks
To non-invasive cardiac output monitoring is no additional risk than the risks
of placing a central venous line and arterial line. These forms of surveillance
are standard hemodynamic monitoring for a HIPEC procedure.
The advantage is that patients may have a shorter hospital stay in the ICU,
less diuretic use and a lower risk of wound healing problems or anastomotic
leaks.
Koekoekslaan 1
3430 EM Nieuwegein
Nederland
Koekoekslaan 1
3430 EM Nieuwegein
Nederland
Listed location countries
Age
Inclusion criteria
age > 18 years
carcinomatosis peritonei
Hipec procedure
Exclusion criteria
no sinusrhythm (No validity of Flowtrac)
Left ventricle dysfunction (severe LVEF < 40%)
seveare coronairy artery disease
Suboptimal macroscopic debulking and aborting the HIPEC procedure
preoperative diuretic use
Design
Recruitment
Medical products/devices used
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 | NL36185.100.11 |