NCT02020538

Limiting IV Chloride to Reduce AKI After Cardiac Surgery

Does Varying the Chloride Content of Intravenous Fluid Alter the Risk of Acute Kidney Injury After Cardiac Surgery?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,298 (actual)
• Sponsor: Bayside Health · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patients Undergoing Cardiothoracic Surgery

Interventions

Type	Name	Description
OTHER	Low-chloride perioperative intravenous fluid strategy	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.
OTHER	High-chloride perioperative intravenous fluid strategy

Timeline

• Start date: 2014-02-03
• Primary completion: 2015-12-09
• Completion: 2016-02-12
• First posted: 2013-12-25
• Last updated: 2020-04-22

Locations

1 site across 1 country: Australia