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Limiting IV Chloride to Reduce AKI After Cardiac Surgery (LICRA)

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ClinicalTrials.gov Identifier: NCT02020538
Recruitment Status : Completed
First Posted : December 25, 2013
Last Update Posted : April 22, 2020
Sponsor:
Collaborator:
Australian and New Zealand College of Anaesthetists
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Patients Undergoing Cardiothoracic Surgery Other: Low-chloride perioperative intravenous fluid strategy Other: High-chloride perioperative intravenous fluid strategy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1298 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Investigator-initiated, prospective, open-label, 4-period sequential study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Does Varying the Chloride Content of Intravenous Fluid Alter the Risk of Acute Kidney Injury After Cardiac Surgery?
Actual Study Start Date : February 3, 2014
Actual Primary Completion Date : December 9, 2015
Actual Study Completion Date : February 12, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
Drug Information available for: Chlorine

Arm Intervention/treatment
Placebo Comparator: Chloride-rich IV fluid
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
Other Name: Chloride-rich IV fluid

Active Comparator: Chloride-poor IV fluid
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
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.
Other Name: Chloride-poor IV fluid




Primary Outcome Measures :
  1. Peak ∆ serum creatinine [ Time Frame: 5 days postoperatively ]
    Maximum change in serum creatinine from baseline

  2. AKI ≥stage2 [ Time Frame: 5 days postoperatively ]
    AKI, ≥stage2, defined by creatinine-based KDIGO criteria


Secondary Outcome Measures :
  1. Individual stages of AKI [ Time Frame: 7 days ]
    Individual stages of AKI, defined by creatinine-based KDIGO criteria

  2. Mortality [ Time Frame: On discharge from hospital (7-30 days) ]
    Mortality

  3. Renal replacement therapy [ Time Frame: On discharge from hospital (7-30 days) ]
    Renal replacement therapy

  4. ICU Length of stay [ Time Frame: On discharge from hospital (7-30 days) ]
    ICU Length of stay

  5. Hospital Length of stay [ Time Frame: On discharge from hospital (7-30 days) ]
    Hospital Length of stay

  6. Time to first extubation [ Time Frame: On discharge from hospital (7-30 days) ]
    Time to first extubation

  7. Red cell transfusion requirement [ Time Frame: Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first ]
    Volume of packed red blood cells transfused

  8. Fresh frozen plasma transfusion requirement [ Time Frame: Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first ]
    Volume of fresh frozen plasma transfused

  9. Platelet transfusion requirement [ Time Frame: Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first ]
    Volume of platelets transfused

  10. Cryoprecipitate transfusion requirement [ Time Frame: Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first ]
    Volume of cryoprecipitate transfused


Other Outcome Measures:
  1. Time-weighted mean serum chloride concentration [ Time Frame: First 5 days and through ICU admission ]
    A time-weighted calculation of mean serum chloride concentration

  2. Incidence of hypernatremia [ Time Frame: On discharge from hospital (7-30 days) ]
    Incidence of hypernatremia (SNa+ >150 mmol/L)

  3. Incidence of hyponatremia [ Time Frame: On discharge from hospital (7-30 days) ]
    Incidence of hyponatremia (SNa+ <130 mmol/L)

  4. Incidence of hyperchloremia [ Time Frame: On discharge from hospital (7-30 days) ]
    Incidence of hyperchloremia (SCl- >110 mmol/L)

  5. Incidence of hypochloremia [ Time Frame: On discharge from hospital (7-30 days) ]
    Incidence of hypochloremia (SCl- <96 mmol/L)

  6. Incidence of acidemia [ Time Frame: On discharge from hospital (7-30 days) ]
    Incidence of acidemia (pH <7.3)

  7. Incidence of alkalemia [ Time Frame: On discharge from hospital (7-30 days) ]
    Incidence of alkalemia (pH >7.5)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All adult patients undergoing surgery by Division of cardiothoracic surgery

Exclusion Criteria:

Nil


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020538


Locations
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Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Bayside Health
Australian and New Zealand College of Anaesthetists
Investigators
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Principal Investigator: David R McIlroy, MBBS, MClinEpi, FANZCA Alfred Hospital and Monash University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT02020538    
Other Study ID Numbers: 382/13
First Posted: December 25, 2013    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: December 2019
Keywords provided by Bayside Health:
Thoracic surgery
cardiac surgery
acute kidney injury
hyperchloremia
intravenous fluid
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases