This primary aim of this study is to test the impact of a strategy of perioperative chloride-restriction through intravenous (IV) fluid therapy on the incidence of acute kidney injury after cardiac surgery. A prospective, open-label, single-centre 4-period sequential study of varying strategies of perioperative IV fluid composition will test the hypothesis that a perioperative protocol for the administration of chloride-poor intravenous fluids compared to chloride-rich intravenous fluids will reduce the incidence of AKI after adult cardiothoracic surgery.
After an initial run-in period of approximately 1 month (using a chloride-rich fluid strategy), the first study period of 5 months will commence, also comprising a chloride-rich perioperative IV fluid therapy strategy (0.9% saline or 4% albumin). This will include intraoperative fluid and postoperative fluid for the duration of stay in the intensive care unit. This will then be followed by a 1-month transition period before a second period of 5 months will commence where perioperative intravenous fluid therapy will consist of chloride-poor fluids (Lactated Ringer's solution or concentrated 20% albumin). A subsequent 1-month transition period will then be followed by a third period of 5 months characterized by perioperative IV fluid therapy with an alternative combination of chloride-poor solutions (PlasmaLyte® 148 or concentrated 20% albumin). A final 1-month transition period will be followed by a fourth and final period of 5 months characterized by a return to perioperative IV fluid therapy with chloride-rich fluids (0.9% saline or 4% albumin). A final 1-month run-off period using a chloride-rich perioperative fluid strategy will follow prior to study completion.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,298
The low-chloride perioperative IV fluid strategy will include the use of PlasmaLyte 148 or Hartmann's solution as the crystalloid of choice and 20% albumin as the colloid of choice.
Alfred Hospital
Melbourne, Victoria, Australia
Peak ∆ serum creatinine
Maximum change in serum creatinine from baseline
Time frame: 5 days postoperatively
AKI ≥stage2
AKI, ≥stage2, defined by creatinine-based KDIGO criteria
Time frame: 5 days postoperatively
Individual stages of AKI
Individual stages of AKI, defined by creatinine-based KDIGO criteria
Time frame: 7 days
Mortality
Mortality
Time frame: On discharge from hospital (7-30 days)
Renal replacement therapy
Renal replacement therapy
Time frame: On discharge from hospital (7-30 days)
ICU Length of stay
ICU Length of stay
Time frame: On discharge from hospital (7-30 days)
Hospital Length of stay
Hospital Length of stay
Time frame: On discharge from hospital (7-30 days)
Time to first extubation
Time to first extubation
Time frame: On discharge from hospital (7-30 days)
Red cell transfusion requirement
Volume of packed red blood cells transfused
Time frame: Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
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Fresh frozen plasma transfusion requirement
Volume of fresh frozen plasma transfused
Time frame: Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Platelet transfusion requirement
Volume of platelets transfused
Time frame: Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Cryoprecipitate transfusion requirement
Volume of cryoprecipitate transfused
Time frame: Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first