Alfred Hospital
Melbourne, Victoria, 3004, Australia
NCT Number: NCT02020538
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Melbourne, Victoria, 3004, Australia
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.
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
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
Other names: Chloride-rich IV fluid
Time frame: 5 days postoperatively
Maximum change in serum creatinine from baseline
Time frame: 5 days postoperatively
AKI, ≥stage2, defined by creatinine-based KDIGO criteria
Time frame: 7 days
Individual stages of AKI, defined by creatinine-based KDIGO criteria
Time frame: On discharge from hospital (7-30 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: Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Volume of packed red blood cells transfused
Time frame: Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Volume of fresh frozen plasma transfused
Time frame: Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Volume of platelets transfused
Time frame: Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Volume of cryoprecipitate transfused
Time frame: First 5 days and through ICU admission
A time-weighted calculation of mean serum chloride concentration
Time frame: On discharge from hospital (7-30 days)
Incidence of hypernatremia (SNa+ >150 mmol/L)
Time frame: On discharge from hospital (7-30 days)
Incidence of hyponatremia (SNa+ <130 mmol/L)
Time frame: On discharge from hospital (7-30 days)
Incidence of hyperchloremia (SCl- >110 mmol/L)
Time frame: On discharge from hospital (7-30 days)
Incidence of hypochloremia (SCl- <96 mmol/L)
Time frame: On discharge from hospital (7-30 days)
Incidence of acidemia (pH <7.3)
Time frame: On discharge from hospital (7-30 days)
Incidence of alkalemia (pH >7.5)
Bayside Health
Other Gov
Does Varying the Chloride Content of Intravenous Fluid Alter the Risk of Acute Kidney Injury After Cardiac Surgery?
Acronym: LICRA
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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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