Comparison of Plasmalyte 148® and Saline for Fluid Resuscitation and Intravenous Fluid Therapy in Critically Ill Adults

GI-CCT7587

The aim of PLUS is to conduct a multi-centre, blinded, randomised, controlled trial (RCT) to determine whether fluid resuscitation and therapy with a "balanced" crystalloid solution (Plasma-Lyte 148®) decreases 90-day mortality in critically ill patients requiring fluid resuscitation when compared with the same treatment using 0.9% sodium chloride (saline)

2017-09-01

2021-03-30

2021-06-30

Completed

Early phase I

5037

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 5037, 'type': 'ACTUAL'}}

2023-08-08