A Phase 3 interventional study of Plasma-Lyte 148 (approx. pH 7.4) IV Infusion and 0.9% SODIUM CHLORIDE 9g/L injection BP in End Stage Kidney Disease, Delayed Graft Function and Kidney Transplant; Complications, sponsored by The University of Queensland. Completed at 18 sites in 2 countries. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by The University of Queensland · Phase 3, Interventional, and Treatment
End-stage kidney disease (ESKD) is a significant, expensive health problem. Kidney transplantation improves survival, quality of life, and is much cheaper than dialysis treatment for ESKD. However sometimes kidney transplants from a deceased donor function poorly after surgery, and a period of continued dialysis is needed, a condition known as delayed graft function (DGF). In addition to complicating recovery, DGF can adversely affect long-term kidney function and the health of the recipient.
Intravenous fluids given during and after transplantation (usually 0.9% sodium chloride or saline) are critical to preserve kidney transplant function, but there is evidence that 0.9% saline may not be the safest fluid to use due to its high chloride content.
BEST Fluids is a randomised controlled trial that aims to find out whether using a balanced low-chloride solution - Plasma-Lyte 148® - as an alternative to normal saline in deceased donor kidney transplantation, will improve kidney transplant function, reduce the impact of DGF, and improve long-term outcomes for patients.
End-stage kidney disease is a significant public health problem worldwide, and its treatment imposes a high healthcare burden and cost. Kidney transplantation is considered the best treatment for ESKD, offering improved survival and quality of life at significantly lower cost that dialysis. However, many kidney transplants fail prematurely due in part due to injury sustained at the time of transplantation. Delayed graft function (DGF), i.e. the requirement for dialysis early after transplantation, affects approximately 30% of deceased donor kidney transplants, and increases the risk of graft failure and mortality.
Intravenous fluids are a critical, albeit inexpensive, aspect of care that impacts early transplant function with normal (0.9%) saline the current standard care at most centres. However, normal saline may in fact be harmful in the setting of kidney transplantation due to its high chloride content relative to plasma, causing metabolic acidosis, acute kidney injury and thus potentially increasing the risk of DGF. Utilising a balanced low-chloride crystalloid solution such as Plasma-Lyte 148® (Plasmalyte) as an alternative to 0.9% saline may therefore improve outcomes after kidney transplantation.
The BEST-Fluids study is an investigator-initiated, pragmatic, registry-based, multi-centre, double -blind randomised, controlled trial. The primary objective of the study is to evaluate the effect in deceased donor kidney transplant recipients of intravenous therapy with Plasmalyte versus 0.9% saline, commencing pre-operatively and continuing until intravenous fluids are no longer required or 48 hours post-transplant (whichever is earliest), on DGF, defined as the requirement for dialysis in the first seven days post-transplant.
Patients admitted for a deceased donor kidney transplant at participating centres will be invited to participate in the study prior to transplant surgery. Following informed consent, participants will be randomised to receive either blinded Plasmalyte or blinded 0.9% saline for all intravenous fluid therapy purposes until 48 hours post-transplant. The volume and rate of fluid therapy will be determined by treating clinicians; all other treatments will be as per local standard of care. Participants will be enrolled, randomised and followed up using ANZDATA, the Australia \& New Zealand Dialysis \& Transplant Registry.
The trial was prospectively registered with Australia New Zealand Clinical Trials Registry (ANZCTR) on 08/03/2017 (ACTRN12617000358347).
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's enrollment of 808 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →The University of Queensland is the lead sponsor of 91 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Plasma-Lyte 148 (approx. pH 7.4) IV Infusion intravenous fluid therapy will be used for all maintenance, replacement and resuscitation purposes from randomization onwards until 48 hours post-transplant, or until fluid therapy is no longer required, if earlier.
Drug: Plasma-Lyte 148 (approx. pH 7.4) IV Infusion
0.9% saline intravenous fluid therapy will be used for all maintenance, replacement and resuscitation purposes from randomization onwards until 48 hours post-transplant, or until fluid therapy is no longer required, if earlier.
Drug: 0.9% SODIUM CHLORIDE 9g/L injection BP
Plasma-Lyte 148 (approx. pH 7.4) IV Infusion is a sterile, clear, non-pyrogenic isotonic solution and when administered intravenously is a source of water, electrolytes and calories. Plasma-Lyte 148 intravenous infusion is indicated as a source of water \& electrolytes or as an alkalinising agent.
Also known as: Plasma-Lyte 148®, Plasmalyte, Balanced crystalloid solution
Drug page: Sodium Chloride
Sodium chloride (0.9% saline) infusion is a sterile, non-pyrogenic solution of sodium chloride in Water for Injections. The concentration of sodium chloride is 154mmol/L. Sodium chloride (0.9%) intravenous infusion is indicated for extra-cellular fluid replacement and in the management of metabolic alkalosis in the presence of fluid loss, and for restoring or maintaining the concentration of sodium and chloride ions.
Also known as: 0.9% saline, Normal saline, Isotonic saline
The proportion of participants with Delayed Graft Function
Delayed Graft Function defined as receiving treatment with any form of dialysis in the first seven days after transplant
Time frame: 7 Days
Early Kidney Transplant Function
Early Kidney Transplant Function, a ranked composite of 1. Duration of Delayed Graft Function Description: Participants who require dialysis within seven days post-transplant, the time from transplant to the final dialysis treatment in days (up to 84 days/12 weeks) will be ranked from best to worst (longer times are worse). 2. Rate of recovery of kidney transplant graft function Description: for participants who do not require dialysis, graft function assessed using the creatinine reduction ratio on post-transplant day two (CRR2) will be ranked from best to worst (smaller reductions are worse).
Time frame: a. Duration of Delayed Graft Function - 12 Weeks; b. Rate of recovery of kidney transplant graft function - 2 Days
Number of dialysis sessions
The number of dialysis sessions
Time frame: First 28 days post-transplant
Total duration of dialysis
The total duration of dialysis in days
Time frame: 12 Weeks
Creatinine reduction ratio from day 1 to day 2 post-transplant
Creatinine reduction ratio from day one to day two measured using serum assay, for those who do not require dialysis within the first 7 days
Time frame: Day 1 to Day 2 post-transplant
Reduction in serum creatinine of greater than or equal to 10%
The proportion of subjects with a reduction in serum creatinine of greater than or equal to 10% on three consecutive days in the first 7 days post-transplant
Time frame: First 7 days post-transplant
Serum creatinine trends over 52 weeks
Serum creatinine trends measured over 52 weeks
Time frame: 12 months
Incidence of serum potassium greater than or equal to 5.5 mmol/L
Serum potassium greater than or equal to 5.5 mmol/L measured by serum assay
Time frame: First 48 hours post-transplant
Peak potassium level
Peak potassium level, measured by serum assay
Time frame: First 48 hours post-transplant
Treatment for hyperkalaemia
Treatment for hyperkalaemia with dialysis, Ca2+-gluconate, insulin, beta-agonists, sodium bicarbonate or ion exchange resins in the first 48 hours post-transplant
Time frame: First 48 hours post-transplant
Incidence of significant fluid overload
Incidence of significant fluid overload defined as \>5% weight gain
Time frame: Baseline to day 2
Aggregate urine output
Aggregate urine output until day 2 post-transplant
Time frame: Until day 2 post-transplant
Requirement for inotropic support (use of vasopressors or other drugs to maintain adequate blood pressure)
Requirement for inotropic support both intra- and post-operatively to Day 2
Time frame: Intra- and post-operatively to Day 2
Number of acute rejection episodes
Number of acute rejection episodes in the first 52 weeks as reported by ANZDATA routine data capture and as assessed by treating physicians
Time frame: 12 months
Number of renal transplant biopsies
Number of renal transplant biopsies performed in the first 28 days post-transplant
Time frame: First 28 days post-transplant
Death from all causes
Death from all causes up to 52 weeks
Time frame: Up to 52 weeks
Graft survival
Graft survival and death-censored graft survival as reported by ANZDATA and assessed by treating physician
Time frame: 12 months
Graft function
Graft function (estimated glomerular filtration rate; eGFR) at 4, 12, 26 and 52 weeks
Time frame: 4, 12, 26 and 52 weeks
Health-related quality of life
Health-related quality of life measured using EuroQol EQ-5D-5L for adults, and EQ-5D-Y in children under 18 years. EQ-5D has descriptive and visual analogue scale (VAS). Descriptive system consists of five dimensions mobility, self-care, usual activities, pain/discomfort and anxiety/depression. VAS records patient's self-rated health on vertical visual analogue scale with endpoints best to worst health with 0 being worst and 100 being best health.
Time frame: Baseline, day 7, day 28, week 12, week 26, and week 52
Length of hospital stay
Length of hospital stay over 12 months using linked data state and country based health data
Time frame: 12 months
Healthcare resource use
Healthcare resource use over 12 months using linked data state and country based health data
Time frame: 12 months
Cost-effectiveness
Cost-effectiveness over 12 months using linked data state and country based health data
Time frame: 12 months
Plan to share: Yes — Yes Individual participant data that underlie the results reported in the primary publication, after de-identification (text, tables, figures and appendices) will be available for individual participant data meta-analysis.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 2 years and ending 5 years following main publication. Proposals may be submitted up to 5 years following article publication. After 5 years, the data will be available in our University's data warehouse but without investigator support other than deposited metadata.
Access criteria: An independent review board will assess proposals based on the following criteria: sound science, benefit-risk balancing and research team expertise.
Ran from Jan 2018 to primary completion in Jul 2021, 42 months.
Of 66 phase 3 interventional studies under Kidney Failure, Chronic, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 48. This study's 42 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Plasma-lyte 148
The University of Queensland