Limiting IV Chloride to Reduce AKI After Cardiac Surgery (LICRA)
Primary Purpose
Patients Undergoing Cardiothoracic Surgery
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Low-chloride perioperative intravenous fluid strategy
High-chloride perioperative intravenous fluid strategy
Sponsored by
About this trial
This is an interventional prevention trial for Patients Undergoing Cardiothoracic Surgery focused on measuring Thoracic surgery, cardiac surgery, acute kidney injury, hyperchloremia, intravenous fluid
Eligibility Criteria
Inclusion Criteria:
All adult patients undergoing surgery by Division of cardiothoracic surgery
Exclusion Criteria:
Nil
Sites / Locations
- Alfred Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Chloride-rich IV fluid
Chloride-poor IV fluid
Arm 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.
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.
Outcomes
Primary Outcome Measures
Peak ∆ serum creatinine
Maximum change in serum creatinine from baseline
AKI ≥stage2
AKI, ≥stage2, defined by creatinine-based KDIGO criteria
Secondary Outcome Measures
Individual stages of AKI
Individual stages of AKI, defined by creatinine-based KDIGO criteria
Mortality
Mortality
Renal replacement therapy
Renal replacement therapy
ICU Length of stay
ICU Length of stay
Hospital Length of stay
Hospital Length of stay
Time to first extubation
Time to first extubation
Red cell transfusion requirement
Volume of packed red blood cells transfused
Fresh frozen plasma transfusion requirement
Volume of fresh frozen plasma transfused
Platelet transfusion requirement
Volume of platelets transfused
Cryoprecipitate transfusion requirement
Volume of cryoprecipitate transfused
Full Information
NCT ID
NCT02020538
First Posted
December 19, 2013
Last Updated
April 20, 2020
Sponsor
Bayside Health
Collaborators
Australian and New Zealand College of Anaesthetists
1. Study Identification
Unique Protocol Identification Number
NCT02020538
Brief Title
Limiting IV Chloride to Reduce AKI After Cardiac Surgery
Acronym
LICRA
Official Title
Does Varying the Chloride Content of Intravenous Fluid Alter the Risk of Acute Kidney Injury After Cardiac Surgery?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
February 3, 2014 (Actual)
Primary Completion Date
December 9, 2015 (Actual)
Study Completion Date
February 12, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayside Health
Collaborators
Australian and New Zealand College of Anaesthetists
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Undergoing Cardiothoracic Surgery
Keywords
Thoracic surgery, cardiac surgery, acute kidney injury, hyperchloremia, intravenous fluid
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Investigator-initiated, prospective, open-label, 4-period sequential study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1298 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chloride-rich IV fluid
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Chloride-poor IV fluid
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Low-chloride perioperative intravenous fluid strategy
Other Intervention Name(s)
Chloride-poor IV fluid
Intervention 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.
Intervention Type
Other
Intervention Name(s)
High-chloride perioperative intravenous fluid strategy
Other Intervention Name(s)
Chloride-rich IV fluid
Primary Outcome Measure Information:
Title
Peak ∆ serum creatinine
Description
Maximum change in serum creatinine from baseline
Time Frame
5 days postoperatively
Title
AKI ≥stage2
Description
AKI, ≥stage2, defined by creatinine-based KDIGO criteria
Time Frame
5 days postoperatively
Secondary Outcome Measure Information:
Title
Individual stages of AKI
Description
Individual stages of AKI, defined by creatinine-based KDIGO criteria
Time Frame
7 days
Title
Mortality
Description
Mortality
Time Frame
On discharge from hospital (7-30 days)
Title
Renal replacement therapy
Description
Renal replacement therapy
Time Frame
On discharge from hospital (7-30 days)
Title
ICU Length of stay
Description
ICU Length of stay
Time Frame
On discharge from hospital (7-30 days)
Title
Hospital Length of stay
Description
Hospital Length of stay
Time Frame
On discharge from hospital (7-30 days)
Title
Time to first extubation
Description
Time to first extubation
Time Frame
On discharge from hospital (7-30 days)
Title
Red cell transfusion requirement
Description
Volume of packed red blood cells transfused
Time Frame
Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Title
Fresh frozen plasma transfusion requirement
Description
Volume of fresh frozen plasma transfused
Time Frame
Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Title
Platelet transfusion requirement
Description
Volume of platelets transfused
Time Frame
Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Title
Cryoprecipitate transfusion requirement
Description
Volume of cryoprecipitate transfused
Time Frame
Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Other Pre-specified Outcome Measures:
Title
Time-weighted mean serum chloride concentration
Description
A time-weighted calculation of mean serum chloride concentration
Time Frame
First 5 days and through ICU admission
Title
Incidence of hypernatremia
Description
Incidence of hypernatremia (SNa+ >150 mmol/L)
Time Frame
On discharge from hospital (7-30 days)
Title
Incidence of hyponatremia
Description
Incidence of hyponatremia (SNa+ <130 mmol/L)
Time Frame
On discharge from hospital (7-30 days)
Title
Incidence of hyperchloremia
Description
Incidence of hyperchloremia (SCl- >110 mmol/L)
Time Frame
On discharge from hospital (7-30 days)
Title
Incidence of hypochloremia
Description
Incidence of hypochloremia (SCl- <96 mmol/L)
Time Frame
On discharge from hospital (7-30 days)
Title
Incidence of acidemia
Description
Incidence of acidemia (pH <7.3)
Time Frame
On discharge from hospital (7-30 days)
Title
Incidence of alkalemia
Description
Incidence of alkalemia (pH >7.5)
Time Frame
On discharge from hospital (7-30 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All adult patients undergoing surgery by Division of cardiothoracic surgery
Exclusion Criteria:
Nil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R McIlroy, MBBS, MClinEpi, FANZCA
Organizational Affiliation
Alfred Hospital and Monash University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
32863142
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.
Results Reference
derived
PubMed Identifier
28343236
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.
Results Reference
derived
Learn more about this trial
Limiting IV Chloride to Reduce AKI After Cardiac Surgery
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