Last updated on February 2019

Plasma-Lyte 148 versUs Saline Study

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hypovolemia
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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 previously received fluid resuscitation (as defined above) prescribed in the ICU during this current ICU admission
  • Patients transferred directly from another ICU who have received 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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.