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?

Sponsors

Lead Sponsor: Bayside Health

Collaborator: Australian and New Zealand College of Anaesthetists

Source 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.

Overall Status Completed
Start Date 2014-02-03
Completion Date 2016-02-12
Primary Completion Date 2015-12-09
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Peak ∆ serum creatinine 5 days postoperatively
AKI ≥stage2 5 days postoperatively
Secondary Outcome
Measure Time Frame
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
Enrollment 1298
Condition
Intervention

Intervention Type: Other

Intervention Name: Low-chloride perioperative intravenous fluid strategy

Description: 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.

Arm Group Label: Chloride-poor IV fluid

Other Name: Chloride-poor IV fluid

Intervention Type: Other

Intervention Name: High-chloride perioperative intravenous fluid strategy

Arm Group Label: Chloride-rich IV fluid

Other Name: Chloride-rich IV fluid

Eligibility

Criteria:

Inclusion Criteria: All adult patients undergoing surgery by Division of cardiothoracic surgery Exclusion Criteria: Nil

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
David R McIlroy, MBBS, MClinEpi, FANZCA Principal Investigator Alfred Hospital and Monash University
Location
Facility: Alfred Hospital
Location Countries

Australia

Verification Date

2019-12-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Chloride-rich IV fluid

Type: Placebo Comparator

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.

Label: Chloride-poor IV fluid

Type: Active Comparator

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.

Acronym LICRA
Study Design Info

Allocation: Non-Randomized

Intervention Model: Sequential Assignment

Intervention Model Description: Investigator-initiated, prospective, open-label, 4-period sequential study

Primary Purpose: Prevention

Masking: None (Open Label)

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