Limiting IV Chloride to Reduce AKI After Cardiac Surgery
- Conditions
- Patients Undergoing Cardiothoracic Surgery
- Registration Number
- NCT02020538
- Lead Sponsor
- Bayside Health
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1298
All adult patients undergoing surgery by Division of cardiothoracic surgery
Nil
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Peak ∆ serum creatinine 5 days postoperatively Maximum change in serum creatinine from baseline
AKI ≥stage2 5 days postoperatively AKI, ≥stage2, defined by creatinine-based KDIGO criteria
- Secondary Outcome Measures
Name Time Method Individual stages of AKI 7 days Individual stages of AKI, defined by creatinine-based KDIGO criteria
Mortality On discharge from hospital (7-30 days) Mortality
Renal replacement therapy On discharge from hospital (7-30 days) Renal replacement therapy
ICU Length of stay On discharge from hospital (7-30 days) ICU Length of stay
Hospital Length of stay On discharge from hospital (7-30 days) Hospital Length of stay
Time to first extubation On discharge from hospital (7-30 days) Time to first extubation
Red cell transfusion requirement Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first Volume of packed red blood cells transfused
Fresh frozen plasma transfusion requirement Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first Volume of fresh frozen plasma transfused
Platelet transfusion requirement Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first Volume of platelets transfused
Cryoprecipitate transfusion requirement Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first Volume of cryoprecipitate transfused
Trial Locations
- Locations (1)
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Alfred Hospital🇦🇺Melbourne, Victoria, Australia