Plasma-Lyte 148® versUs Saline Study

PHASE4CompletedINTERVENTIONAL
Enrollment

5,037

Participants

Timeline

Start Date

September 1, 2017

Primary Completion Date

March 30, 2021

Study Completion Date

June 30, 2021

Conditions
Hypovolemia
Interventions
DRUG

Plasma-Lyte 148®

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.

DRUG

0.9% sodium chloride

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).

Trial Locations (51)

740

North Shore Hospital, Takapuna

1023

Auckland City Hospital (CVICU), Auckland

1142

Auckland City Hospital (DCCM), Auckland

1640

Middlemore Hospital, Auckland

2050

Royal Prince Alfred Hospital, Camperdown

2076

The Sydney Adventist Hospital, Wahroonga

2077

Hornsby Ku-ring-gai Hospital, Hornsby

2139

Concord Repatriation General Hospital, Concord

2145

Westmead Hospital, Westmead

2148

Blacktown Hospital, Blacktown

2170

Liverpool Hospital, Liverpool

2217

St George Hospital, Kogarah

2229

The Sutherland Hospital, Caringbah

2250

Gosford Hospital, Gosford

2298

Calvary Mater Newcastle, Waratah

2500

Wollongong Hospital, Wollongong

2650

Wagga Wagga Rural Referral Hospital, Wagga Wagga

2751

Nepean, Penrith

3010

Rotorua Hospital, Rotorua

3011

Footscray Hospital, Western Health, Footscray

3021

Sunshine Hospital, Western Health, St Albans

3050

Royal Melbourne Hospital, Parkville

3084

Austin Hospital, Heidelberg

3110

Tauranga Hospital, Tauranga

3128

Box Hill Hospital, Box Hill

3135

Maroondah Hospital, Ringwood East

3168

Monash Medical Centre, Clayton

3175

Dandenong Hospital, Dandenong

3199

Frankston Hospital, Frankston

3240

Waikato Hospital, Hamilton

3350

Ballarat Health Services, Ballarat

3550

Bendigo Hospital, Bendigo

4020

Redcliffe Hospital, Redcliffe

4029

Royal Brisbane and Women's Hospital, Herston

4066

The Wesley Hospital, Auchenflower

4101

Mater Misericordiae, South Brisbane

4102

Princess Alexandra Hospital, Woolloongabba

4120

Hawkes Bay, Hastings

4215

Gold Coast University Hospital, Southport

4226

Robina Hospital, Robina

4350

Toowoomba Hospital, Toowoomba

5000

Royal Adelaide Hospital, Adelaide

5014

Hutt Hospital, Lower Hutt

6021

Wellington Hospital, Newtown

6150

St John of God Murdoch Hospital, Murdoch

6165

Fiona Stanley Hospital, Murdoch

7000

Royal Hobart Hospital, Hobart

7010

Nelson Hospital, Nelson

7250

Launceston General Hospital, Launceston

8140

Christchurch Hospital, Christchurch

Unknown

Royal North Shore Hospital, St Leonards

All Listed Sponsors
collaborator

Australian and New Zealand Intensive Care Society Clinical Trials Group

NETWORK

collaborator

Baxter Healthcare Corporation

INDUSTRY

lead

The George Institute

OTHER

NCT02721654 - Plasma-Lyte 148® versUs Saline Study | Biotech Hunter | Biotech Hunter