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
Medical Research Institute of New Zealand
260 participants
Apr 1, 2014
Interventional
Conditions
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
Eligibility
Inclusion Criteria2
- Adult patients > 18 years
- Elective or emergency cardiac surgery
Exclusion Criteria5
- 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
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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. 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.
Locations(1)
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ACTRN12614000289617