Hepatic Complication Clinical Trial
Official title:
Implications of Variable Intraoperative Fluid Strategies Upon the Hepatic Outcome in Hepatobiliary Surgery
compare the effect of two different protocol of fluid therapy in patients undergoing elective hepatobiliary surgery under general anesthesia regarding hemodynamics and SGPT change pre- and postoperative.
Fluid administration during and after surgery is an essential part of postoperative care to
maintain the patients' fluid and biochemical balance. Abdominal surgical procedures are
associated with dehydration from preoperative fasting , bowel preparation, and intra- and
postoperative fluid and electrolyte loss(1). So, perioperative fluid management has been a
topic of much debate over years and has intensified especially over the past several years.
The controversies include the type of fluid, the timing of administration and the volume
administrated. Following much discussions and ongoing controversy on colloids versus
crystalloids(2-5) and the ideal composition of the various intravenous solutions(6-8),the
main focus more recently has been on the volume of fluids.
Fluid therapy strategies have been developed and implemented in clinical practice over
several decades. The data suggest that aggressive or liberal intraoperative fluid
resuscitation is harmful during open abdominal operation, whereas a restrictive fluid
protocol has better outcomes, including fewer postoperative complications and a shorter
discharge time. (9-11).
However , a restrictive fluid regimen has several limitations (12). Overly restricted or
inadequate fluid administration may lead to insufficient intravascular volume, tissue
hypoperfusion, cellular oxygenation impairment and potential organ dysfunction(13), prolonged
recovery of bowel function, and impair tissue oxygenation, which might ultimately impair
wound healing including healing of anastomosis.(14, 15) Recently, The Pleth variability index
(PVI) derived from respiratory variations in peripheral perfusion index (PI) has been
suggested to be an effective dynamic indicator of fluid responsiveness. Different from other
invasive dynamic indices, PVI provides clinicians with a numerical value obtained
noninvasively. (16-18) PVI is calculated as [(PImax - PImin)/PImax] X 100, where PImax and
PImin represent the maximal and the minimal value, respectively, of the plethysmographic
perfusion index (PI) over one respiratory cycle (16, 19). PI is the ratio between pulsatile
and no pulsatile infrared light absorption from the pulse oximeter, and it is physiologically
equivalent to the amplitude of the plethysmographic waveform (20). A PVI value of >13% before
volume expansion discriminated between fluid responders and non-responders with 81%
sensitivity and 100% specificity.
An extremely important feature of fluid therapy is ability to modulate inflammatory response
in all its aspects with impact on a rate of neutrophil activation and modulation of cytokine
and adhesive molecules expression. Isotonic sodium chloride solution and Ringer's lactate
solution were shown to have pro-inflammatory properties while so called low volume therapy.
Saline solution seems to be the most pro-inflammatory infusion fluid exerting negative impact
on both macro- and microcirculation (21). Infusions of high volume of sodium chloride result
in elevated serum chloride levels leading to acid-base imbalance and increase of free
hydrogen ions (22).
Some available literature data show potential impact of Ringer's lactate therapy on induction
of inflammatory response (23) but other reports do not support such phenomenon (24). Acetates
similarly to lactates act as buffers and are easily broken down to bicarbonates. The
difference between them is that lactates are metabolized mainly in the liver while acetates
are metabolized in all body cells. The latter is especially beneficial in liver
insufficiency, lactic acidosis and microcirculation insufficiency leading to organ
hypoperfusion.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01888302 -
Sirolimus, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients At High Risk for Cholangiocarcinoma Recurrence After Liver Transplant or Surgery
|
Phase 1 | |
| Terminated |
NCT01907802 -
Dabrafenib in Treating Patients With Solid Tumors and Kidney or Liver Dysfunction
|
Phase 1 | |
| Active, not recruiting |
NCT02925689 -
Dabrafenib in Treating Patients With Solid Tumors and Kidney or Liver Dysfunction
|
Phase 1 |