Primary objective: To evaluate the expected increase of the Microvascular Flow Index perioperative using a SDF-imaging device and the systemic inflammatory response by measuring inflammation biomarkers.Secondary objective: To learn more about the…
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To describe gastrointestinal microcirculation and cytokine kinetics (CRP, white
blood cell, IL-6, IL-8, IL 10 and TNF-* levels) in blood samples during and
after CS-HIPEC procedure.
Secondary outcome
Body (core) temperature, Cardiac output (CO), Stroke volume (SV), Stroke Volume
Variation (SVV), these later parameters are automatically measured by the
flow-trac/vigileo and thus only accesable when an arterial catherter is
inserted.
Background summary
Cytoreductive Surgery (CS) with Hyperthermic IntraPEritoneal Chemotherapy
(HIPEC) is associated with postoperative morbidity like abdominal sepsis.
Postoperative levels of systemic inflammation biomarkers (cytokines) have been
found to correlate with the magnitude of surgery. Pro- and anti-inflammatory
cytokines, such as interleukin-6 (IL-6), IL-8 and Tumor Necrosis Factor-*, are
crucial mediators in this process. Microcirculatory distress may form one of
the earliest stages of sepsis progressing into multiple organ failure.
Sidestream dark field (SDF) imaging is a promising, non-invasive method to
visualize the microcirculation and assess the degree of microvascularisation.
In previous studies, sublingually measured microvascular alterations in
patients with severe sepsis have been shown to correlate with worse outcome.
Clinical research on microcirculation has gained much interest in the last
years. We hypothesize that an inflammatory response develops following
CS-HIPEC. To our knowledge, no study has been performed to evaluate this
inflammatory response and the effects on the intestinal microcirculation during
and after CS-HIPEC procedure.
Study objective
Primary objective: To evaluate the expected increase of the Microvascular Flow
Index perioperative using a SDF-imaging device and the systemic inflammatory
response by measuring inflammation biomarkers.
Secondary objective: To learn more about the pathogenesis of gastrointestinal
microvascular alterations due to systemic inflammation. This knowledge may aid
us to develop future intervention strategies, aimed at improving peripheral
microvascular flow, which could be beneficial for patient outcome.
Study design
A prospective, single centre, observational, clinical study.
Study burden and risks
The extent of burden and risk associated with participation in this study is
very limited. Using Sidestream Dark Field imaging during a laparotomy is a
non-invasive technique requiring a minimal amount of time. Most serum samples
can be collected from the intraoperative placed arterial line. For
postoperative follow-up two venous punctures are needed to collect remaining
blood samples. A venous puncture is a well known minimal invasive procedure
with limited burden for the participants of this research.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
* Patients > 18 years of age
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Undergoing a CS-HIPEC procedure for colorectal carcinoma
Chemotherapeutic agent used for HIPEC is Mitomycin-C
Signed informed consent
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
* Age <18 years
* Atrial fibrillation (because of possible interference with FloTrac*/Vigileo* cardiac output monitor)
* Left ventricular ejection fraction *30%
* Serious pulmonary disease (resting pO2 <90% at room air)
* Renal failure (clearance <30 ml/min as calculated using the Modification of Diet in Renal Disease formula)
* Inadequate bone marrow function (ANC *1.5 x 109/L and/or platelet count * 100 x 109/L)
* Pre-existing liver failure (Serum bilirubin * 2 x ULN, and/or ALAT and ASAT * 3 x ULN or need for partial hepatectomy during CS
* History of auto-immune or chronic inflammatory disease and/or on immunomodulatory medication
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 | NL48369.100.14 |