Clinical trial NCT02020538: Limiting IV Chloride to Reduce AKI After Cardiac Surgery
Official title: Does Varying the Chloride Content of Intravenous Fluid Alter the Risk of Acute Kidney Injury After Cardiac Surgery?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Undergoing Cardiothoracic Surgery
Keywords: Thoracic surgery
cardiac surgery
acute kidney injury
hyperchloremia
intravenous fluid
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
Collaborators: name: Australian and New Zealand College of Anaesthetists
First posted: 2013-12-25
Enrollment: 1298
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Investigator-initiated, prospective, open-label, 4-period sequential study
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

All adult patients undergoing surgery by Division of cardiothoracic surgery

Exclusion Criteria:

Nil

Primary outcomes:
measure: Peak ∆ serum creatinine
timeFrame: 5 days postoperatively
measure: AKI ≥stage2
timeFrame: 5 days postoperatively
Secondary outcomes:
measure: Individual stages of AKI
timeFrame: 7 days
measure: Mortality
timeFrame: On discharge from hospital (7-30 days)
measure: Renal replacement therapy
timeFrame: On discharge from hospital (7-30 days)
measure: ICU Length of stay
timeFrame: On discharge from hospital (7-30 days)
measure: Hospital Length of stay
timeFrame: On discharge from hospital (7-30 days)
measure: Time to first extubation
timeFrame: On discharge from hospital (7-30 days)
measure: Red cell transfusion requirement
timeFrame: Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
measure: Fresh frozen plasma transfusion requirement
timeFrame: Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
measure: Platelet transfusion requirement
timeFrame: Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
measure: Cryoprecipitate transfusion requirement
timeFrame: Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Other outcomes:
measure: Time-weighted mean serum chloride concentration
timeFrame: First 5 days and through ICU admission
measure: Incidence of hypernatremia
timeFrame: On discharge from hospital (7-30 days)
measure: Incidence of hyponatremia
timeFrame: On discharge from hospital (7-30 days)
measure: Incidence of hyperchloremia
timeFrame: On discharge from hospital (7-30 days)
measure: Incidence of hypochloremia
timeFrame: On discharge from hospital (7-30 days)
measure: Incidence of acidemia
timeFrame: On discharge from hospital (7-30 days)
measure: Incidence of alkalemia
timeFrame: On discharge from hospital (7-30 days)
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
affiliation: Alfred Hospital and Monash University
name: David R McIlroy, MBBS, MClinEpi, FANZCA
role: PRINCIPAL_INVESTIGATOR
References:
citation: McIlroy DR, Murphy D, Shotwell MS, Bhatia D. Peak Serum Chloride and Hyperchloremia in Patients Undergoing Cardiac Surgery Is Not Explained by Chloride-Rich Intravenous Fluid Alone: A Post-Hoc Analysis of the LICRA Trial. J Cardiothorac Vasc Anesth. 2021 May;35(5):1321-1331. doi: 10.1053/j.jvca.2020.07.085. Epub 2020 Aug 7.
citation: McIlroy D, Murphy D, Kasza J, Bhatia D, Wutzlhofer L, Marasco S. Effects of restricting perioperative use of intravenous chloride on kidney injury in patients undergoing cardiac surgery: the LICRA pragmatic controlled clinical trial. Intensive Care Med. 2017 Jun;43(6):795-806. doi: 10.1007/s00134-017-4772-6. Epub 2017 Mar 25.