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Limiting IV Chloride to Reduce AKI After Cardiac Surgery

Does Varying the Chloride Content of Intravenous Fluid Alter the Risk of Acute Kidney Injury After Cardiac Surgery?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02020538
Acronym
LICRA
Enrollment
1298
Registered
2013-12-25
Start date
2014-02-03
Completion date
2016-02-12
Last updated
2020-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Undergoing Cardiothoracic Surgery

Keywords

Thoracic surgery, cardiac surgery, acute kidney injury, hyperchloremia, intravenous fluid

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.

Interventions

OTHERLow-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.

OTHERHigh-chloride perioperative intravenous fluid strategy

Sponsors

Australian and New Zealand College of Anaesthetists
CollaboratorOTHER
Bayside Health
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Investigator-initiated, prospective, open-label, 4-period sequential study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All adult patients undergoing surgery by Division of cardiothoracic surgery

Exclusion criteria

Nil

Design outcomes

Primary

MeasureTime frameDescription
Peak ∆ serum creatinine5 days postoperativelyMaximum change in serum creatinine from baseline
AKI ≥stage25 days postoperativelyAKI, ≥stage2, defined by creatinine-based KDIGO criteria

Secondary

MeasureTime frameDescription
Hospital Length of stayOn discharge from hospital (7-30 days)Hospital Length of stay
Time to first extubationOn discharge from hospital (7-30 days)Time to first extubation
Individual stages of AKI7 daysIndividual stages of AKI, defined by creatinine-based KDIGO criteria
MortalityOn discharge from hospital (7-30 days)Mortality
Red cell transfusion requirementIntraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred firstVolume of packed red blood cells transfused
Fresh frozen plasma transfusion requirementIntraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred firstVolume of fresh frozen plasma transfused
Platelet transfusion requirementIntraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred firstVolume of platelets transfused
Cryoprecipitate transfusion requirementIntraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred firstVolume of cryoprecipitate transfused
Renal replacement therapyOn discharge from hospital (7-30 days)Renal replacement therapy
ICU Length of stayOn discharge from hospital (7-30 days)ICU Length of stay

Other

MeasureTime frameDescription
Incidence of hyperchloremiaOn discharge from hospital (7-30 days)Incidence of hyperchloremia (SCl- \>110 mmol/L)
Incidence of hypochloremiaOn discharge from hospital (7-30 days)Incidence of hypochloremia (SCl- \<96 mmol/L)
Incidence of acidemiaOn discharge from hospital (7-30 days)Incidence of acidemia (pH \<7.3)
Incidence of alkalemiaOn discharge from hospital (7-30 days)Incidence of alkalemia (pH \>7.5)
Incidence of hypernatremiaOn discharge from hospital (7-30 days)Incidence of hypernatremia (SNa+ \>150 mmol/L)
Incidence of hyponatremiaOn discharge from hospital (7-30 days)Incidence of hyponatremia (SNa+ \<130 mmol/L)
Time-weighted mean serum chloride concentrationFirst 5 days and through ICU admissionA time-weighted calculation of mean serum chloride concentration

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026