NCT02020538

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,298

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 25, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

February 3, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2016

Completed
Last Updated

April 22, 2020

Status Verified

December 1, 2019

Enrollment Period

1.8 years

First QC Date

December 19, 2013

Last Update Submit

April 20, 2020

Conditions

Patients Undergoing Cardiothoracic Surgery

Keywords

Thoracic surgerycardiac surgeryacute kidney injuryhyperchloremiaintravenous fluid

Outcome Measures

Primary Outcomes (2)

  • Peak ∆ serum creatinine

    Maximum change in serum creatinine from baseline

    5 days postoperatively

  • AKI ≥stage2

    AKI, ≥stage2, defined by creatinine-based KDIGO criteria

    5 days postoperatively

Secondary Outcomes (10)

  • 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)

  • +5 more secondary outcomes

Other Outcomes (7)

  • Time-weighted mean serum chloride concentration

    First 5 days and through ICU admission

  • Incidence of hypernatremia

    On discharge from hospital (7-30 days)

  • Incidence of hyponatremia

    On discharge from hospital (7-30 days)

  • +4 more other outcomes

Study Arms (2)

Chloride-rich IV fluid

PLACEBO COMPARATOR

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

Other: High-chloride perioperative intravenous fluid strategy

Chloride-poor IV fluid

ACTIVE COMPARATOR

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.

Other: Low-chloride perioperative intravenous fluid strategy

Interventions

Low-chloride perioperative intravenous fluid strategyOTHER

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.

Also known as: Chloride-poor IV fluid
Chloride-poor IV fluid
High-chloride perioperative intravenous fluid strategyOTHER
Also known as: Chloride-rich IV fluid
Chloride-rich IV fluid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult patients undergoing surgery by Division of cardiothoracic surgery

You may not qualify if:

  • Nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Related Publications (2)

  • 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.

    PMID: 32863142DERIVED

  • 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.

    PMID: 28343236DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • David R McIlroy, MBBS, MClinEpi, FANZCA

    Alfred Hospital and Monash University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Investigator-initiated, prospective, open-label, 4-period sequential study
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2013

First Posted

December 25, 2013

Study Start

February 3, 2014

Primary Completion

December 9, 2015

Study Completion

February 12, 2016

Last Updated

April 22, 2020

Record last verified: 2019-12

Locations

AU(1)