HypovolemiaPhase 4PLUSNCT02721654
Plasma-Lyte 148® versUs Saline Study
A Phase 4 study testing Plasma-Lyte 148® and 0.9% sodium chloride in people with Hypovolemia, run by The George Institute at 51 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypovolemia
- What is being tested?
- Plasma-Lyte 148® and 0.9% sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,037 participants
- Where
- 51 sitesin 2 countries
- Study dates
- 1 Sep 2017to 30 Jun 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
51 sites in 2 countries.
51 sites in 2 countries
Australia39 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
The Wesley Hospital
Auchenflower, Queensland, 4066
Ballarat Health Services
Ballarat, Victoria, 3350
Bendigo Hospital
Bendigo, Victoria, 3550
Blacktown Hospital
Blacktown, New South Wales, 2148
Box Hill Hospital
Box Hill, Victoria, 3128
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
The Sutherland Hospital
Caringbah, New South Wales, 2229
Monash Medical Centre
Clayton, Victoria, 3168
Concord Repatriation General Hospital
Concord, New South Wales, 2139
Dandenong Hospital
Dandenong, Victoria, 3175
Footscray Hospital, Western Health
Footscray, Victoria, 3011
Frankston Hospital
Frankston, Victoria, 3199
Gosford Hospital
Gosford, New South Wales, 2250
Austin Hospital
Heidelberg, Victoria, 3084
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Royal Hobart Hospital
Hobart, Tasmania, 7000
Hornsby Ku-ring-gai Hospital
Hornsby, New South Wales, 2077
St George Hospital
Kogarah, New South Wales, 2217
Launceston General Hospital
Launceston, Tasmania, 7250
Liverpool Hospital
Liverpool, New South Wales, 2170
St John of God Murdoch Hospital
Murdoch, Western Australia, 6150
Fiona Stanley Hospital
Murdoch, Western Australia, 6165
Royal Melbourne Hospital
Parkville, Victoria, 3050
Nepean
Penrith, New South Wales, 2751
Redcliffe Hospital
Redcliffe, Queensland, 4020
Maroondah Hospital
Ringwood East, Victoria, 3135
Robina Hospital
Robina, Queensland, 4226
Mater Misericordiae
South Brisbane, Queensland, 4101
Gold Coast University Hospital
Southport, Queensland, 4215
Sunshine Hospital, Western Health
St Albans, Victoria, 3021
Royal North Shore Hospital
St Leonards, New South Wales
Toowoomba Hospital
Toowoomba, Queensland, 4350
Wagga Wagga Rural Referral Hospital
Wagga Wagga, New South Wales, 2650
The Sydney Adventist Hospital
Wahroonga, New South Wales, 2076
Calvary Mater Newcastle
Waratah, New South Wales, 2298
Westmead Hospital
Westmead, New South Wales, 2145
Wollongong Hospital
Wollongong, New South Wales, 2500
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
New Zealand12 sites
Auckland City Hospital (CVICU)
Auckland, 1023
Auckland City Hospital (DCCM)
Auckland, 1142
Middlemore Hospital
Auckland, 1640
Christchurch Hospital
Christchurch, Canterbury, 8140
Waikato Hospital
Hamilton, 3240
Hawkes Bay
Hastings, Camberley, 4120
Hutt Hospital
Lower Hutt, Wellington Region, 5014
Nelson Hospital
Nelson, 7010
Wellington Hospital
Newtown, Wellington Region, 6021
Rotorua Hospital
Rotorua, Bay of Plenty, 3010
North Shore Hospital
Takapuna, Auckland, 740
Tauranga Hospital
Tauranga, 3110
About this study
Official title: Comparison of Plasmalyte 148® and Saline for Fluid Resuscitation and Intravenous Fluid Therapy in Critically Ill Adults
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)
Read the detailed description
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 scientific, ethical and health economic imperative to provide an accurate and reliable estimate of the comparative risks versus benefit of Plasma-Lyte 148® versus 0.9% saline.
The PLUS study is a prospective, multi-centre, parallel group, concealed, blinded, randomised, controlled trial.
The study will test the hypothesis that in a heterogeneous population of critically ill adults, random assignment to Plasma-Lyte 148® for intravascular volume resuscitation and crystalloid fluid therapy in the Intensive Care Unit (ICU) results in different 90-day all-cause mortality when compared with random assignment to 0.9% sodium chloride (saline) for the same treatment.
Each patient who meets all inclusion criteria and no exclusion criteria will be randomised to receive either Plasma-Lyte 148® or 0.9% saline for all resuscitation episodes and for all compatible crystalloid therapy while in ICU for up to 90 days after randomisation. Other crystalloid fluids may be used as carrier fluids for the infusion of any drug for which either Plasma-Lyte 148® or 0.9% saline is considered incompatible.The study treatments will be supplied in identical 1000 ml bags and treatment assignment will be concealed.
The volume of study fluid being administered will be titrated against clinical endpoints determined by the treating clinicians and reviewed as clinically appropriate during the period of resuscitation and ICU treatment.
- Conditions
- Hypovolemia
- Being tested
- Plasma-Lyte 148®, 0.9% sodium chloride
- Keywords
- Plasma-Lyte, Sodium chloride, Saline, Fluid resuscitation, Intravenous fluid therapy, Critically ill, Critical care
- Medical subject headings
- Hypovolemia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma-Lyte 148®Drug
Also called Balanced crystalloid solution
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.
0.9% sodium chlorideDrug
Also called Saline
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).
| Study group | Role | What they receive |
|---|---|---|
| Plasma-Lyte 148® | Experimental | Following 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). Receives: Drug: Plasma-Lyte 148® |
| 0.9% sodium chloride | Active comparator | Following 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). Receives: Drug: 0.9% sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death from all causes
Measured: At 90 days after randomisation
Secondary outcomes (10)
Mean and peak serum creatinine concentration
Measured: First seven days
ICU, hospital and 28 day all-cause mortality
Measured: 28 days and 6 months after randomisation
Duration of ICU stay
Measured: 28 days and 90 days after randomisation
Duration of Hospital stay
Measured: 28 days and 90 days after randomisation
Proportion of patients newly treated with renal replacement therapy
Measured: up to 90 days after randomisation.
Duration of mechanical ventilation in ICU
Measured: 90 days after randomisation
Proportion of patients treated with and duration of treatment with vasoactive drugs
Measured: 90 days after randomisation
Quality of life assessment using the EQ-5D-5L questionnaire
Measured: At 6 months after randomisation
Maximum post-randomisation increase in serum creatinine in ICU during the index hospital admission.
Measured: 90 days after randomisation
Healthcare services usage during the six months after randomisation by healthcare record linkage using state and national data linkage units
Measured: During the six months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study start1 Sep 2017
- Primary completion30 Mar 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypovolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5,037 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Australian and New Zealand Intensive Care Society Clinical Trials Group, Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Simon Finfer, Professor, Study chair, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721654
- Sponsor's protocol ID
- GI-CCT7587
- Other IDs
- U1111-1178-8334
- Acronym
- PLUS
- Status last verified
- Aug 2023
- First submitted
- 15 Mar 2016
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 35041780
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Plasmalyte 148® and Saline for Fluid Resuscitation and Intravenous Fluid Therapy in Critically Ill Adults
- ClinicalTrials.gov ID
- NCT02721654
- Acronym / sponsor ID
- PLUS / GI-CCT7587
- Conditions
- Hypovolemia
- Keywords
- Plasma-Lyte, Sodium chloride, Saline, Fluid resuscitation, Intravenous fluid therapy, Critically ill, Critical care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,037 participants (actual)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- Australian and New Zealand Intensive Care Society Clinical Trials Group, Baxter Healthcare Corporation
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 29 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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 scientific, ethical and health economic imperative to provide an accurate and reliable estimate of the comparative risks versus benefit of Plasma-Lyte 148® versus 0.9% saline.
The PLUS study is a prospective, multi-centre, parallel group, concealed, blinded, randomised, controlled trial.
The study will test the hypothesis that in a heterogeneous population of critically ill adults, random assignment to Plasma-Lyte 148® for intravascular volume resuscitation and crystalloid fluid therapy in the Intensive Care Unit (ICU) results in different 90-day all-cause mortality when compared with random assignment to 0.9% sodium chloride (saline) for the same treatment.
Each patient who meets all inclusion criteria and no exclusion criteria will be randomised to receive either Plasma-Lyte 148® or 0.9% saline for all resuscitation episodes and for all compatible crystalloid therapy while in ICU for up to 90 days after randomisation. Other crystalloid fluids may be used as carrier fluids for the infusion of any drug for which either Plasma-Lyte 148® or 0.9% saline is considered incompatible.The study treatments will be supplied in identical 1000 ml bags and treatment assignment will be concealed.
The volume of study fluid being administered will be titrated against clinical endpoints determined by the treating clinicians and reviewed as clinically appropriate during the period of resuscitation and ICU treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plasma-Lyte 148® | Experimental | Drug: Plasma-Lyte 148®Following 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 comparator | Drug: 0.9% sodium chlorideFollowing 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma-Lyte 148®Also: Balanced crystalloid solutionPlasma-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. | Drug | Plasma-Lyte 148® |
| 0.9% sodium chlorideAlso: SalineThe 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). | Drug | 0.9% sodium chloride |
Primary outcome
Death from all causes
Time frame: At 90 days after randomisation
10 secondary outcomes
Mean and peak serum creatinine concentration
Time frame: First seven days
ICU, hospital and 28 day all-cause mortality
Time frame: 28 days and 6 months after randomisation
Duration of ICU stay
Time frame: 28 days and 90 days after randomisation
Duration of Hospital stay
Time frame: 28 days and 90 days after randomisation
Proportion of patients newly treated with renal replacement therapy
Time frame: up to 90 days after randomisation.
Duration of mechanical ventilation in ICU
Time frame: 90 days after randomisation
Proportion of patients treated with and duration of treatment with vasoactive drugs
Time frame: 90 days after randomisation
Quality of life assessment using the EQ-5D-5L questionnaire
Time frame: At 6 months after randomisation
Maximum post-randomisation increase in serum creatinine in ICU during the index hospital admission.
Time frame: 90 days after randomisation
Healthcare services usage during the six months after randomisation by healthcare record linkage using state and national data linkage units
Time frame: During the six months after randomisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Derived from this study: PubMed 35041780Finfer 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Finfer, Professor study chair
The George Institute
51 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Plasma-Lyte 148® and 0.9% sodium chloride in people with Hypovolemia, run by The George Institute at 51 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death from all causes (time frame: At 90 days after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02721654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.