Limiting IV Chloride to Reduce AKI After Cardiac Surgery (LICRA)

Bayside Health

Status: Completed

Conditions: Patients Undergoing Cardiothoracic Surgery

Treatments: Other: Low-chloride perioperative intravenous fluid strategy; Other: High-chloride perioperative intravenous fluid strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT02020538

382/13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,298 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

All adult patients undergoing surgery by Division of cardiothoracic surgery

Exclusion criteria

Nil

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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1,298 participants in 2 patient groups, including a placebo group

Chloride-rich IV fluid

Placebo Comparator group

Description:

The chloride-rich strategy will include 0.9% saline as the perioperative crystalloid of choice with 4% albumin as the perioperative colloid of choice.

Treatment:

Other: High-chloride perioperative intravenous fluid strategy

Chloride-poor IV fluid

Active Comparator group

Description:

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.

Treatment:

Other: Low-chloride perioperative intravenous fluid strategy