Intestinal microvascular alterations and cytokine kinetics following cytoreductive surgery with hyperthermic intraperitoneal chemotherapy

Withdrawn

Conditions: gastrointestinal micorcirculation
gastrointestinal microvascularisation
10017998

Registration Number: NL-OMON40837

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 15

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To describe gastrointestinal microcirculation and cytokine kinetics (CRP, white<br /><br>blood cell, IL-6, IL-8, IL 10 and TNF-* levels) in blood samples during and<br /><br>after CS-HIPEC procedure. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Body (core) temperature, Cardiac output (CO), Stroke volume (SV), Stroke Volume<br /><br>Variation (SVV), these later parameters are automatically measured by the<br /><br>flow-trac/vigileo and thus only accesable when an arterial catherter is<br /><br>inserted.</p><br>