Does Varying the Chloride Content of Intravenous Fluid Alter the Risk of Acute Kidney Injury After Cardiac Surgery?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,298
- Locations
- 2
- Primary Endpoint
- Peak ∆ serum creatinine
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All adult patients undergoing surgery by Division of cardiothoracic surgery
Exclusion Criteria
- Not provided
Arms & Interventions
Chloride-poor IV fluid
A low-chloride strategy of perioperative IV fluid will include PlasmaLyte 148 or Hartmann's solution as the crystalloid of choice with 20% albumin as the colloid of choice.
Intervention: Low-chloride perioperative intravenous fluid strategy (Other)
Chloride-rich IV fluid
The chloride-rich strategy will include 0.9% saline as the perioperative crystalloid of choice with 4% albumin as the perioperative colloid of choice.
Intervention: High-chloride perioperative intravenous fluid strategy (Other)
Outcomes
Primary Outcomes
Peak ∆ serum creatinine
Time Frame: 5 days postoperatively
Maximum change in serum creatinine from baseline
AKI ≥stage2
Time Frame: 5 days postoperatively
AKI, ≥stage2, defined by creatinine-based KDIGO criteria
Secondary Outcomes
- Individual stages of AKI(7 days)
- Mortality(On discharge from hospital (7-30 days))
- Renal replacement therapy(On discharge from hospital (7-30 days))
- ICU Length of stay(On discharge from hospital (7-30 days))
- Hospital Length of stay(On discharge from hospital (7-30 days))
- Time to first extubation(On discharge from hospital (7-30 days))
- Red cell transfusion requirement(Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first)
- Fresh frozen plasma transfusion requirement(Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first)
- Platelet transfusion requirement(Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first)
- Cryoprecipitate transfusion requirement(Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first)