Patients Undergoing Cardiothoracic SurgeryLICRANCT02020538
Limiting IV Chloride to Reduce AKI After Cardiac Surgery
A study testing Low-chloride perioperative intravenous fluid strategy and High-chloride perioperative intravenous fluid strategy in people with Patients Undergoing Cardiothoracic Surgery, run by Bayside Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Undergoing Cardiothoracic Surgery
- What is being tested?
- Low-chloride perioperative intravenous fluid strategy and High-chloride perioperative intravenous fluid strategy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,298 participants
- Where
- 1 siteAustralia
- Study dates
- 3 Feb 2014to 12 Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients undergoing surgery by Division of cardiothoracic surgery
Who cannot join
- Nil
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Varying the Chloride Content of Intravenous Fluid Alter the Risk of Acute Kidney Injury After Cardiac Surgery?
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.
Read the 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.
- Being tested
- Low-chloride perioperative intravenous fluid strategy, High-chloride perioperative intravenous fluid strategy
- Keywords
- Thoracic surgery, cardiac surgery, acute kidney injury, hyperchloremia, intravenous fluid
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-chloride perioperative intravenous fluid strategyOther
Also called Chloride-poor IV fluid
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.
High-chloride perioperative intravenous fluid strategyOther
Also called Chloride-rich IV fluid
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Low-chloride perioperative intravenous fluid strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak ∆ serum creatinine
Maximum change in serum creatinine from baseline
Measured: 5 days postoperatively
AKI ≥stage2
AKI, ≥stage2, defined by creatinine-based KDIGO criteria
Measured: 5 days postoperatively
Secondary outcomes (10)
Individual stages of AKI
Individual stages of AKI, defined by creatinine-based KDIGO criteria
Measured: 7 days
Mortality
Mortality
Measured: On discharge from hospital (7-30 days)
Renal replacement therapy
Renal replacement therapy
Measured: On discharge from hospital (7-30 days)
ICU Length of stay
ICU Length of stay
Measured: On discharge from hospital (7-30 days)
Hospital Length of stay
Hospital Length of stay
Measured: On discharge from hospital (7-30 days)
Time to first extubation
Time to first extubation
Measured: On discharge from hospital (7-30 days)
Red cell transfusion requirement
Volume of packed red blood cells transfused
Measured: Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Fresh frozen plasma transfusion requirement
Volume of fresh frozen plasma transfused
Measured: Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Platelet transfusion requirement
Volume of platelets transfused
Measured: Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Cryoprecipitate transfusion requirement
Volume of cryoprecipitate transfused
Measured: Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2013 (estimated)
- Study start3 Feb 2014
- Primary completion9 Dec 2015
- Study completion12 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing Cardiothoracic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Investigator-initiated, prospective, open-label, 4-period sequential study
- Masking
- None (open label)
- Enrolment
- 1,298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- Australian and New Zealand College of Anaesthetists
- Responsible party
- Sponsor
- Investigators
- David R McIlroy, MBBS, MClinEpi, FANZCA, Principal investigator, Alfred Hospital and Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020538
- Sponsor's protocol ID
- 382/13
- Acronym
- LICRA
- Status last verified
- Dec 2019
- First submitted
- 19 Dec 2013
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32863142McIlroy 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.
PubMed 28343236
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Varying the Chloride Content of Intravenous Fluid Alter the Risk of Acute Kidney Injury After Cardiac Surgery?
- ClinicalTrials.gov ID
- NCT02020538
- Acronym / sponsor ID
- LICRA / 382/13
- Keywords
- Thoracic surgery, cardiac surgery, acute kidney injury, hyperchloremia, intravenous fluid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,298 participants (actual)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- Australian and New Zealand College of Anaesthetists
- Study start
- 3 Feb 2014 (actual)
- Primary completion
- 9 Dec 2015 (actual)
- Study completion
- 12 Feb 2016 (actual)
- First posted
- 25 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Investigator-initiated, prospective, open-label, 4-period sequential study
| Arm | Type | Receives |
|---|---|---|
| Chloride-rich IV fluid | Placebo comparator | Other: High-chloride perioperative intravenous fluid strategyThe chloride-rich strategy will include 0.9% saline as the perioperative crystalloid of choice with 4% albumin as the perioperative colloid of choice. |
| Chloride-poor IV fluid | Active comparator | Other: Low-chloride perioperative intravenous fluid strategyA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients undergoing surgery by Division of cardiothoracic surgery
Key exclusion criteria (1 listed)
- Nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-chloride perioperative intravenous fluid strategyAlso: Chloride-poor IV fluidThe 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. | Other | Chloride-poor IV fluid |
| High-chloride perioperative intravenous fluid strategyAlso: Chloride-rich IV fluid | Other | Chloride-rich IV fluid |
Primary outcome
Peak ∆ serum creatinine
Time frame: 5 days postoperatively
Maximum change in serum creatinine from baseline
AKI ≥stage2
Time frame: 5 days postoperatively
AKI, ≥stage2, defined by creatinine-based KDIGO criteria
10 secondary outcomes
Individual stages of AKI
Time frame: 7 days
Mortality
Time frame: On discharge from hospital (7-30 days)
Renal replacement therapy
Time frame: On discharge from hospital (7-30 days)
ICU Length of stay
Time frame: On discharge from hospital (7-30 days)
Hospital Length of stay
Time frame: On discharge from hospital (7-30 days)
Time to first extubation
Time frame: On discharge from hospital (7-30 days)
Red cell transfusion requirement
Time frame: Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Fresh frozen plasma transfusion requirement
Time frame: Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Platelet transfusion requirement
Time frame: Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Cryoprecipitate transfusion requirement
Time frame: Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Derived from this study: PubMed 32863142McIlroy 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.
- Derived from this study: PubMed 28343236McIlroy 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.
Related trials for Patients Undergoing Cardiothoracic Surgery
Recruiting
Virtual Reality and Olfactory Stimuli Multimodal Intervention to Reduce Post-Operative Pain and Anxiety in Patients Undergoing Cardiothoracic Surgery
Postoperative Pain, Anxiety Postoperative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R McIlroy, MBBS, MClinEpi, FANZCA principal investigator
Alfred Hospital and Monash University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-chloride perioperative intravenous fluid strategy and High-chloride perioperative intravenous fluid strategy in people with Patients Undergoing Cardiothoracic Surgery, run by Bayside Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak ∆ serum creatinine (time frame: 5 days postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02020538, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.