Plasma-Lyte 148® versUs Saline Study

Launched by THE GEORGE INSTITUTE · Mar 22, 2016

Keywords

ClinConnect Summary

Fluid resuscitation is a fundamental component of the management of acutely and critically ill patients and the choice of fluid is a longstanding issue of debate.

Worldwide, 0.9% saline has traditionally been the most widely used resuscitation fluid, however its use is increasingly challenged by emerging evidence that suggests its high chloride content may have clinically important adverse effects and that resuscitation with so-called "balanced" or "buffered" crystalloids (such as Plasma-Lyte 148®) offer patients better outcomes.

Given the limitations of current evidence, there is now a s...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The patient will receive fluid resuscitation defined as a bolus of fluid, prescribed to be administered over one hour or less to increase or maintain intravascular volume that is in addition to maintenance fluids, or specific fluids used to replace non-physiological fluid losses
• • The patient is expected to be in the ICU the day after tomorrow
• • The patient is not expected to be well enough to be eating tomorrow
• • An arterial or central venous catheter is in situ, or placement is imminent as part of routine management
• • Both Plasma-Lyte 148® and 0.9% saline are considered equally appropriate for the patient
• • The requirement for fluid resuscitation is supported by at least one of seven pre-specified clinical signs: heart rate \> 90 beats per minute; systolic blood pressure \< 100 mmHg or mean arterial pressure \< 75 mmHg; central venous pressure \< 10 mmHg; pulmonary artery wedge pressure \< 12 mmHg; capillary refill time \> 1 second; OR urine output \< 0.5 ml/kg for at least one hour
• Exclusion Criteria:
• • Age less than 18 years
• • Patients who have received more than 500mls of fluid resuscitation (as defined above) prescribed in the ICU during this current ICU admission
• • Patients transferred directly from another ICU who have received more than 500mls of fluid resuscitation (as defined above) during that ICU admission
• • Contraindication to either study fluid e.g. previous allergic reaction to Plasma-Lyte 148®
• • Patients admitted to the ICU with specific fluid requirements: the treatment of burns; following liver transplantation surgery; for correction of specific electrolyte abnormalities
• • Patients with traumatic brain injury or those considered at risk of developing cerebral oedema
• • Patients in whom death is deemed imminent and inevitable
• • Patients with an underlying disease process with a life expectancy of \<90 days
• • Patients in whom it is unlikely the primary outcome can be ascertained
• • Patients who have previously been enrolled in PLUS
• • Known or suspected pregnancy

Trial Officials