Limiting IV Chloride to Reduce AKI After Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1298 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-03

Study Completion Date

2016-02-12

Brief Summary

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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.

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Detailed Description

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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

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Patients Undergoing Cardiothoracic Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Investigator-initiated, prospective, open-label, 4-period sequential study

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

High-chloride perioperative intravenous fluid strategy

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Low-chloride perioperative intravenous fluid strategy

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER