Postoperative Inflammation Clinical Trial
Official title:
Volume Replacement With HES 130/0.4 Attenuates Inflammatory Response to Major Abdominal Surgery Compared to Ringer's Lactate (RL); the Effect on Cytokines and Matrix Metalloproteinases
Various stimuli such as trauma, infection and major surgery may alter the physiologic immune
balance and initiate systemic inflammatory processes. This pathophysiological event is
characterized by the release of potent inflammatory mediators into the circulation.
Among these, pro- and anti-inflammatory cytokines such as interleukin-6 (IL-6), IL-8 or
IL-10, ICAM-1 play a dominant role as local or systemic regulators in the acute inflammatory
response. Recent studies have also investigated the role of matrix metalloproteinases (MMPs)
in the inflammatory response. The MMPs constitute a family of enzymes that are structurally
related neutral proteinases. MMPs can degrade essentially all extracellular matrix (ECM)
components and play an important role in wound healing and remodeling of the ECM. The
Tissutal Inhibitor MetalloProteine (TIMPs) are important regulator of MMPs activity.
The inflammatory response coming of surgery mainly affects surgical patients' outcome. Many
factors may attributed to this response, such as the kind of operation, the extent of
surgical trauma, the patient's medical history and therapy, as well as the type of
anesthesia used. Apart from that, the kind of fluids administered for volume replacement was
revealed to alter the inflammatory processes. Several studies have addressed on this issue
mainly involved abdominal surgery and provided compelling evidence that perioperative fluid
optimization produces benefits for the patient, with regard to inflammatory biomarkers such
as cytokines, matrix metalloproteinases, intercellular adhesion molecule-1(ICAM-1). They
support that the different volume replacement strategies, using only crystalloids or
combination of crystalloids with colloids (HES 130/0,4), may have important impact on immune
response. However, the relevant studies investigated different inflammatory biomarkers, and
usually involved either metalloproteinases, and their inhibitors (TIMPs) or cytokines.
In our study we investigated the hypothesis that intra- and postoperative volume replacement
with HES attenuates inflammatory response to elective abdominal surgery compared to RL fluid
therapy. For this purpose both metalloproteinases, MMP-9, MMP-13, their inhibitor, TIMP-1,
cytokines, IL-6, IL-8 and the intercellular adhesion molecule-1, ICAM-1 were investigated
postoperatively. Their changes during the first 24 postoperative hours consisted our primary
outcomes.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)
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