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Completed

NCT Number: NCT02020538

Limiting IV Chloride to Reduce AKI 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All adult patients undergoing surgery by Division of cardiothoracic surgery

Exclusion criteria

Nil

Treatment and study plan

Low-chloride perioperative intravenous fluid strategy

Other

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 names: Chloride-poor IV fluid

High-chloride perioperative intravenous fluid strategy

Other

Other names: Chloride-rich IV fluid

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Bayside Health

Other Gov

Collaborators

  • Australian and New Zealand College of Anaesthetists

Registry information

Official study title

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

Acronym: LICRA

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Dec 25, 2013
Registry last updated
Apr 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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