NCT02721654 (PLUS) is a Phase 4 clinical trial of Plasma-Lyte 148® in Hypovolemia, sponsored by The George Institute.

Who is sponsoring NCT02721654?

NCT02721654 is sponsored by The George Institute.

What drugs are being tested in NCT02721654?

Interventions in NCT02721654: Plasma-Lyte 148®, 0.9% sodium chloride.

What condition does NCT02721654 study?

NCT02721654 studies Hypovolemia.

Is NCT02721654 still recruiting?

NCT02721654 is currently completed. Last updated 8 August 2023.

Last reviewed 2023-08-08 · How we verify

NCT02721654: PLUS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Plasma-Lyte 148® versUs Saline Study

Completed Phase 4 Last updated 8 August 2023

What this trial tests

Phase 4 trial testing Plasma-Lyte 148® in Hypovolemia in 5,037 participants. Completed in 30 June 2021.

Timeline

1 September 2017

Primary endpoint
30 March 2021

30 June 2021

Quick facts

Lead sponsor	The George Institute
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	5,037
Start date	1 September 2017
Primary completion	30 March 2021
Estimated completion	30 June 2021
Sites	51 locations across New Zealand, Australia

Drugs / interventions tested

Plasma-Lyte 148®
0.9% sodium chloride

Conditions studied

Hypovolemia — all drugs for Hypovolemia →

Sponsor

The George Institute

Who can join

18 and older, any sex, with Hypovolemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Controversies in acute kidney injury: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Conference.
Ostermann M, Bellomo R, Burdmann EA, Doi K, et al · · 2020 · cited 384× · PMID 32709292 · DOI 10.1016/j.kint.2020.04.020
Balanced Multielectrolyte Solution versus Saline in Critically Ill Adults.
Finfer S, Micallef S, Hammond N, Navarra L, et al · · 2022 · cited 179× · PMID 35041780 · DOI 10.1056/nejmoa2114464
Buffered solutions versus 0.9% saline for resuscitation in critically ill adults and children.
Antequera Martín AM, Barea Mendoza JA, Muriel A, Sáez I, et al · · 2019 · cited 28× · PMID 31334842 · DOI 10.1002/14651858.cd012247.pub2
Saline versus balanced crystalloids for intravenous fluid therapy in the emergency department: study protocol for a cluster-randomized, multiple-crossover trial.
Self WH, Semler MW, Wanderer JP, Ehrenfeld JM, et al · · 2017 · cited 27× · PMID 28407811 · DOI 10.1186/s13063-017-1923-6
Personalised fluid resuscitation in the ICU: still a fluid concept?
van Haren F. · · 2017 · cited 21× · PMID 29297387 · DOI 10.1186/s13054-017-1909-5
Saline Compared to Balanced Crystalloid in Patients With Diabetic Ketoacidosis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Alghamdi NA, Major P, Chaudhuri D, Tsui J, et al · · 2022 · cited 18× · PMID 35018349 · DOI 10.1097/cce.0000000000000613
STandard versus Accelerated initiation of Renal Replacement Therapy in Acute Kidney Injury: Study Protocol for a Multi-National, Multi-Center, Randomized Controlled Trial.
STARRT-AKI Investigators. · · 2019 · cited 18× · PMID 31218013 · DOI 10.1177/2054358119852937
Multicountry survey of emergency and critical care medicine physicians' fluid resuscitation practices for adult patients with early septic shock.
McIntyre L, Rowe BH, Walsh TS, Gray A, et al · · 2016 · cited 16× · PMID 27388345 · DOI 10.1136/bmjopen-2015-010041

Verify or expand the search:

Other recruiting trials for Hypovolemia

Currently open trials in the same condition.

NCT07492511 — Renal and Hepatic Abnormal Doppler Patterns in Trauma · recruiting
NCT06591234 — Reliability of Internal Jugular Ultrasound : an Observational Transversal Study Conducted Using Images Registered From P · active not recruiting
NCT05931601 — Early Initiated Vasopressor Therapy in the Emergency Department · Phase 3 · recruiting

Other The George Institute trials

Trials by the same sponsor.

NCT07231315 — INTERACT4 Expansion - Validation Study · not yet recruiting
NCT04157231 — Essential Acute Stroke Care in Low Resource Settings: a Pilot studY · NA · not yet recruiting
NCT06935760 — Optimised Treatment for Hypertension Trial · NA · not yet recruiting
NCT06409364 — FLudrocortisone Administration in Aneurysmal Subarachnoid Haemorrhage · Phase 2 · recruiting
NCT06058585 — The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02721654 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The George Institute
Last refreshed: 8 August 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02721654.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing