Intraoperative fluid therapy for patients undergoing elective liver resection
A Randomized, Blinded, Multicentre Non-inferiority Study Comparing the Acid-base Effects of Plasmalyte and Hartmann’s solution in Patients undergoing Liver Resection
Austin Hospital
50 participants
Apr 1, 2010
Interventional
Conditions
Summary
Acid-base disorders are frequently associated with liver dysfunction and may occur in patients undergoing partial liver resection. Liver resection decreases the working liver mass and causes a variable degree of liver insufficiency that in turn, may cause or aggravate metabolic acidosis. The quantitative acid-base effects of fluid therapy during liver resection are unclear with few reported studies. For patients undergoing liver resection, the most frequently administered intravenous crystalloid (clear) fluids are Hartmann’s solution, Normal Saline, and to a lesser extent, Plasmalyte. Normal Saline is not considered an acceptable fluid for prolonged perioperative administration due to its high chloride content that results in hyperchloremic metabolic acidosis. Therefore, both Hartmann’s Solution and Plasmalyte, being more “balanced” solutions compared to Normal Saline, remain the fluids of choice for patients undergoing hepatic resection. However there are no studies to determine which of these fluid has a more favourable acid-base profile. We propose to conduct a prospective, multicentre-centre, blinded, randomized non-inferiority trial to test whether Plasmalyte solution is associated with similar or improved metabolic status (non-inferiority) than Hartmann’s solution. Adult patients undergoing elective hepatic resection will be randomized to receive either Plasmalyte or Hartmann’s solution for all crystalloid fluid therapy during elective liver resection surgery. Primary aim: to examine the effect of Plasmalyte or Hartmann’s solution on acid-base status (measured by base excess). Secondary aims: to compare changes in plasma lactate concentration, effect on NGAL (a novel marker for acute kidney injury), need for blood and blood products, need for mechanical ventilation and its duration, length of hospital stay and survival to hospital discharge. Another factor that may affect acid-base status after liver resection is perioperative kidney injury. In research conducted in the Intensive Care Unit at Austin Hospital, it was found that a new marker for early postoperative kidney injury called NGAL (neutrophil gelatinase associated lipocalin) can be used to predict acute kidney injury in patients undergoing major cardiac surgery. From the published data, the incidence of acute kidney injury after elective hepatic resection is between 10-15%. The value of NGAL after liver resection has not been examined, therefore we also propose to examine if the acid-base status effects of the study fluids have any influence on the incidence of postoperative acute kidney injury. Number of recruiting hospitals: 3 (Austin Hospital, Monash Medical Centre, Peter MaCallum Cancer Centre) Number of patients planned for involvement at each hospital: 15- 20
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Interventions
The intravenous fluids most frequently used in perioperative care in Australia are Hartmann’s solution, Normal Saline, and to a lesser extent, Plasmalyte. One mechanism where perioperative fluid therapy can change acid-base status is when a high chloride concentration found in fluids like Normal Saline causes a hyperchloremic metabolic acidosis. For this reason, Normal Saline is no longer considered a suitable intraoperative fluid replacement therapy for many major surgical procedures, and Hartmann’s Solution and Plasmalyte have become the crystalloid solutions of choice. These solutions are now termed “balanced” solutions as they contain less chloride and have more favourable acid-base profiles. The quantitative acid-base effects of fluid therapy during liver resection however is unclear and there are few studies directly comparing Hartmann’s solution and Plasmalyte in this setting. In this study all participants undergoing hepatic resection will be randomised to receive either Hartmanns's solution or Plasmalyte solution for intraoperative crystalloid fluid replacement therapy. General anaesthesia will be managed by a group of specialist anaesthetists using a protocol designed to standardise patient care for patients undergoing hepatic resection at our institution. Induction of anaesthesia will consists of a balanced technique, and anaesthesia and analgesia will be provided as part of routine care. Routine monitoring will include continuous electrocardiography, pulse oximetry, capnography, invasive arterial blood pressure, central venous pressure, urine output and core body temperature. Intra-operative normothermia will be maintained with warm fluids and a forced-air warming device. Intravenous fluid protocol: Preoperatively. Patients will be fasted as per Hospital protocols. Clear oral fluids (water, tea/coffee with no milk products, clear apple juice) are allowed up to 4 hours before surgery. Prior to anaesthesia and surgery patients will not receive any additional intravenous fluid boluses. Intraoperatively: Patients will receive their allocated fluid, Hartmann’s solution or Plasmalyte as the sole crystalloid during their surgery. The fluids will be provided in deidentified bags, provided by Baxter Healthcare, to will blind the anaesthetist to the allocated fluid. As per standard practice for patients undergoing liver at our institution, the administration of fluids will be reduced and central venous pressure will be maintained at less than 6 mmHg for the duration of hepatic parenchymal resection. After hepatic resection, an infusion of warm crystalloid fluids will be administered to render patients euvolaemic. The crystalloid fluid solution will be infused at a maintenance rate 1.5-2 ml/kg/hr. Additional crystalloid boluses to replace surgical blood loss will consist of ~3 mls of crystalloid solution for every 1 ml of blood lost. Urine output will be maintained at greater than 0.5 ml/kg/h, and systolic blood pressure maintained within 20% of the pre-operative value. The use of water to control plasma sodium, dextrose for the treatment of hypoglycaemia, and blood products to correct anaemia or coagulopathy will be at the discretion of treating clinicians and in accordance with hospital protocols. The anaesthetist managing the patient may choose to use colloid in addition to the crystalloid. To avoid the acid-base effects of different colloids being a confounder in this study, the colloid used in this study will be 20% Albumex (CLS) . We think this is a rational choice as it is supplied free of charge by CSL laboratory to all hospitals in Australia, and has a favorable acid base profile for use in liver surgery. At the completion of surgery the use of the trial fluid (Hartmanns or Plasmalyte) will discontinue and postoperative intravenous fluid therapy (type/amount and duration) will be continued at the discretion of the attending surgeon and perioperative clinician.
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ACTRN12610000147088