Limiting IV Chloride to Reduce AKI After Cardiac Surgery

Patients Undergoing Cardiothoracic Surgery Clinical Trial

— LICRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02020538
• Other study ID #: 382/13
• Status: Completed
• Phase: N/A
• Start date: February 3, 2014
• Est. completion date: February 12, 2016

Study information

• Verified date: December 2019
• Source: Bayside Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1298
• Est. completion date: February 12, 2016
• Est. primary completion date: December 9, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All adult patients undergoing surgery by Division of cardiothoracic surgery

Exclusion Criteria:

Nil

Related Conditions & MeSH terms

• Acute Kidney Injury
• Patients Undergoing Cardiothoracic Surgery

Intervention

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.
• High-chloride perioperative intravenous fluid strategy

Locations

Country	Name	City	State
Australia	Alfred Hospital	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Bayside Health	Australian and New Zealand College of Anaesthetists

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time-weighted mean serum chloride concentration	A time-weighted calculation of mean serum chloride concentration	First 5 days and through ICU admission
Other	Incidence of hypernatremia	Incidence of hypernatremia (SNa+ >150 mmol/L)	On discharge from hospital (7-30 days)
Other	Incidence of hyponatremia	Incidence of hyponatremia (SNa+ <130 mmol/L)	On discharge from hospital (7-30 days)
Other	Incidence of hyperchloremia	Incidence of hyperchloremia (SCl- >110 mmol/L)	On discharge from hospital (7-30 days)
Other	Incidence of hypochloremia	Incidence of hypochloremia (SCl- <96 mmol/L)	On discharge from hospital (7-30 days)
Other	Incidence of acidemia	Incidence of acidemia (pH <7.3)	On discharge from hospital (7-30 days)
Other	Incidence of alkalemia	Incidence of alkalemia (pH >7.5)	On discharge from hospital (7-30 days)
Primary	Peak ? serum creatinine	Maximum change in serum creatinine from baseline	5 days postoperatively
Primary	AKI =stage2	AKI, =stage2, defined by creatinine-based KDIGO criteria	5 days postoperatively
Secondary	Individual stages of AKI	Individual stages of AKI, defined by creatinine-based KDIGO criteria	7 days
Secondary	Mortality	Mortality	On discharge from hospital (7-30 days)
Secondary	Renal replacement therapy	Renal replacement therapy	On discharge from hospital (7-30 days)
Secondary	ICU Length of stay	ICU Length of stay	On discharge from hospital (7-30 days)
Secondary	Hospital Length of stay	Hospital Length of stay	On discharge from hospital (7-30 days)
Secondary	Time to first extubation	Time to first extubation	On discharge from hospital (7-30 days)
Secondary	Red cell transfusion requirement	Volume of packed red blood cells transfused	Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Secondary	Fresh frozen plasma transfusion requirement	Volume of fresh frozen plasma transfused	Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Secondary	Platelet transfusion requirement	Volume of platelets transfused	Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Secondary	Cryoprecipitate transfusion requirement	Volume of cryoprecipitate transfused	Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first