Skip to content

A single centre nested cohort study investigating the safety and efficacy of using 0.9 % saline or Plasma-Lyte(Registered Trademark) 148 as post-operative fluid therapy in adults undergoing cardiac surgery

A single centre nested cohort study investigating the safety and efficacy of using 0.9 % saline or Plasma-Lyte "(Registered Trademark)" as post-operative fluid therapy in adults undergoing cardiac surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000289617
Enrollment
251
Registered
2014-03-19
Start date
2014-04-01
Completion date
2014-10-13
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

0.9% saline has been used in clinical practice for fluid resuscitation and general fluid therapy since the 1880s. While it is the most commonly used IV resuscitation fluid in the world, recent data raise the possibility that using 0.9% saline for intravenous therapy may be related to increased blood transfusion requirement following major surgery compared to Plasma-Lyte (Registered Trademark)" 148 . Current data are insufficient to recommend clinical practice change and further data from an interventional trial are urgently needed

Interventions

This study is conducted as a single centre nested cohort study within the SPLIT study (0.9 % Saline versus Plasma-Lyte 148 for Intensive Care Fluid Therapy). Patients enrolled into the SPLIT study, following cardiac surgery .During the study period the intensive care unit will be randomly assigned to a 7 week period of administration of trial fluid. There is a double crossover approach so that the each strategy is given twice. Plasma-lyte 148 for intravenous fluid therapy in intensive care. T

This study is conducted as a single centre nested cohort study within the SPLIT study (0.9 % Saline versus Plasma-Lyte 148 for Intensive Care Fluid Therapy). Patients enrolled into the SPLIT study, following cardiac surgery .During the study period the intensive care unit will be randomly assigned to a 7 week period of administration of trial fluid. There is a double crossover approach so that the each strategy is given twice. Plasma-lyte 148 for intravenous fluid therapy in intensive care. The rate, duration, and frequency of fluid administration will determined by the treated clinician. All fluid used for either fluid resuscitation or crystalloid rehydration will be Plasma-Lyte 148 unless a specific indication exists for another fluid.

Sponsors

Medical Research Institute of New Zealand
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adult patients > 18 years Elective or emergency cardiac surgery

Exclusion criteria

Patients who are <18 years in age Patients who are expected to require renal replacement therapy within six hours of ICU admission Patients who are usually on dialysis for end stage renal failure Patients who are admitted to the ICU solely for consideration of organ donation or for palliative care Patients previously enrolled in the SPLIT trial

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026