Plasma-Lyte 148® versUs Saline Study
PLUS
Comparison of Plasmalyte 148® and Saline for Fluid Resuscitation and Intravenous Fluid Therapy in Critically Ill Adults
2 other identifiers
interventional
5,037
2 countries
51
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2017
Longer than P75 for phase_4
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2016
CompletedFirst Posted
Study publicly available on registry
March 29, 2016
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedAugust 8, 2023
August 1, 2023
3.6 years
March 15, 2016
August 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Death from all causes
At 90 days after randomisation
Secondary Outcomes (10)
Mean and peak serum creatinine concentration
First seven days
ICU, hospital and 28 day all-cause mortality
28 days and 6 months after randomisation
Duration of ICU stay
28 days and 90 days after randomisation
Duration of Hospital stay
28 days and 90 days after randomisation
Proportion of patients newly treated with renal replacement therapy
up to 90 days after randomisation.
- +5 more secondary outcomes
Study Arms (2)
Plasma-Lyte 148®
EXPERIMENTALFollowing randomisation, each study participant will receive either Plasma-Lyte 148® or 0.9% saline alone for all resuscitation episodes and for all compatible intravenous crystalloid therapy while in ICU (for up to 90 days).
0.9% sodium chloride
ACTIVE COMPARATORFollowing randomisation, each study participant will receive either Plasma-Lyte 148® or 0.9% saline alone for all resuscitation episodes and for all compatible intravenous crystalloid therapy while in ICU (for up to 90 days).
Interventions
Plasma-Lyte 148 (approx pH 7.4) IV infusion is a sterile, clear nonpyrogenic isotonic solution \& when administered intravenously it is a source of water, electrolytes \& calories. Plasma-Lyte 148 intravenous infusion is indicated as a source of water \& electrolytes or as an alkalinising agent.
The active ingredient is sodium chloride formulated in Water for Injections. The chemical name is sodium chloride with molecular formula NaCl. Sodium Chloride (0.9%) intravenous infusion preparation is a sterile \& non-pyrogenic solution \& is indicated for extracellular fluid replacement \& in the management of metabolic alkalosis in the presence of fluid loss, \& for restoring or maintaining the concentration of sodium \& chloride ions. As sodium chloride intravenous infusion is administered to the systemic circulation by intravenous infusion, the bioavailability (absorption) of the active components is complete (100 per cent).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Blacktown Hospital
Blacktown, New South Wales, 2148, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
The Sutherland Hospital
Caringbah, New South Wales, 2229, Australia
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Gosford Hospital
Gosford, New South Wales, 2250, Australia
Hornsby Ku-ring-gai Hospital
Hornsby, New South Wales, 2077, Australia
St George Hospital
Kogarah, New South Wales, 2217, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Nepean
Penrith, New South Wales, 2751, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Wagga Wagga Rural Referral Hospital
Wagga Wagga, New South Wales, 2650, Australia
The Sydney Adventist Hospital
Wahroonga, New South Wales, 2076, Australia
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Wollongong Hospital
Wollongong, New South Wales, 2500, Australia
The Wesley Hospital
Auchenflower, Queensland, 4066, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Redcliffe Hospital
Redcliffe, Queensland, 4020, Australia
Robina Hospital
Robina, Queensland, 4226, Australia
Mater Misericordiae
South Brisbane, Queensland, 4101, Australia
Gold Coast University Hospital
Southport, Queensland, 4215, Australia
Toowoomba Hospital
Toowoomba, Queensland, 4350, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Launceston General Hospital
Launceston, Tasmania, 7250, Australia
Ballarat Health Services
Ballarat, Victoria, 3350, Australia
Bendigo Hospital
Bendigo, Victoria, 3550, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Dandenong Hospital
Dandenong, Victoria, 3175, Australia
Footscray Hospital, Western Health
Footscray, Victoria, 3011, Australia
Frankston Hospital
Frankston, Victoria, 3199, Australia
Austin Hospital
Heidelberg, Victoria, 3084, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Maroondah Hospital
Ringwood East, Victoria, 3135, Australia
Sunshine Hospital, Western Health
St Albans, Victoria, 3021, Australia
St John of God Murdoch Hospital
Murdoch, Western Australia, 6150, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6165, Australia
North Shore Hospital
Takapuna, Auckland, 740, New Zealand
Rotorua Hospital
Rotorua, Bay of Plenty, 3010, New Zealand
Hawkes Bay
Hastings, Camberley, 4120, New Zealand
Christchurch Hospital
Christchurch, Canterbury, 8140, New Zealand
Hutt Hospital
Lower Hutt, Wellington Region, 5014, New Zealand
Wellington Hospital
Newtown, Wellington Region, 6021, New Zealand
Auckland City Hospital (CVICU)
Auckland, 1023, New Zealand
Auckland City Hospital (DCCM)
Auckland, 1142, New Zealand
Middlemore Hospital
Auckland, 1640, New Zealand
Waikato Hospital
Hamilton, 3240, New Zealand
Nelson Hospital
Nelson, 7010, New Zealand
Tauranga Hospital
Tauranga, 3110, New Zealand
Related Publications (1)
Finfer S, Micallef S, Hammond N, Navarra L, Bellomo R, Billot L, Delaney A, Gallagher M, Gattas D, Li Q, Mackle D, Mysore J, Saxena M, Taylor C, Young P, Myburgh J; PLUS Study Investigators and the Australian New Zealand Intensive Care Society Clinical Trials Group. Balanced Multielectrolyte Solution versus Saline in Critically Ill Adults. N Engl J Med. 2022 Mar 3;386(9):815-826. doi: 10.1056/NEJMoa2114464. Epub 2022 Jan 18.
PMID: 35041780DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Simon Finfer, Professor
The George Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2016
First Posted
March 29, 2016
Study Start
September 1, 2017
Primary Completion
March 30, 2021
Study Completion
June 30, 2021
Last Updated
August 8, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share