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| Name | Class |
|---|---|
| Australian and New Zealand College of Anaesthetists | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chloride-rich IV fluid | Placebo Comparator | The chloride-rich strategy will include 0.9% saline as the perioperative crystalloid of choice with 4% albumin as the perioperative colloid of choice. |
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| Chloride-poor IV fluid | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak ∆ serum creatinine | Maximum change in serum creatinine from baseline | 5 days postoperatively |
| AKI ≥stage2 | AKI, ≥stage2, defined by creatinine-based KDIGO criteria | 5 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Individual stages of AKI | Individual stages of AKI, defined by creatinine-based KDIGO criteria | 7 days |
| Mortality | Mortality | On discharge from hospital (7-30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted mean serum chloride concentration | A time-weighted calculation of mean serum chloride concentration | First 5 days and through ICU admission |
| Incidence of hypernatremia | Incidence of hypernatremia (SNa+ >150 mmol/L) |
Inclusion Criteria:
All adult patients undergoing surgery by Division of cardiothoracic surgery
Exclusion Criteria:
Nil
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| Name | Affiliation | Role |
|---|---|---|
| David R McIlroy, MBBS, MClinEpi, FANZCA | Alfred Hospital and Monash University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32863142 | Derived | McIlroy DR, Murphy D, Shotwell MS, Bhatia D. Peak Serum Chloride and Hyperchloremia in Patients Undergoing Cardiac Surgery Is Not Explained by Chloride-Rich Intravenous Fluid Alone: A Post-Hoc Analysis of the LICRA Trial. J Cardiothorac Vasc Anesth. 2021 May;35(5):1321-1331. doi: 10.1053/j.jvca.2020.07.085. Epub 2020 Aug 7. | |
| 28343236 |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Investigator-initiated, prospective, open-label, 4-period sequential study
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| High-chloride perioperative intravenous fluid strategy | Other |
|
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| Renal replacement therapy | Renal replacement therapy | On discharge from hospital (7-30 days) |
| ICU Length of stay | ICU Length of stay | On discharge from hospital (7-30 days) |
| Hospital Length of stay | Hospital Length of stay | On discharge from hospital (7-30 days) |
| Time to first extubation | Time to first extubation | On discharge from hospital (7-30 days) |
| 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 |
| 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 |
| Platelet transfusion requirement | Volume of platelets transfused | Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first |
| Cryoprecipitate transfusion requirement | Volume of cryoprecipitate transfused | Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first |
| On discharge from hospital (7-30 days) |
| Incidence of hyponatremia | Incidence of hyponatremia (SNa+ <130 mmol/L) | On discharge from hospital (7-30 days) |
| Incidence of hyperchloremia | Incidence of hyperchloremia (SCl- >110 mmol/L) | On discharge from hospital (7-30 days) |
| Incidence of hypochloremia | Incidence of hypochloremia (SCl- <96 mmol/L) | On discharge from hospital (7-30 days) |
| Incidence of acidemia | Incidence of acidemia (pH <7.3) | On discharge from hospital (7-30 days) |
| Incidence of alkalemia | Incidence of alkalemia (pH >7.5) | On discharge from hospital (7-30 days) |
| McIlroy D, Murphy D, Kasza J, Bhatia D, Wutzlhofer L, Marasco S. Effects of restricting perioperative use of intravenous chloride on kidney injury in patients undergoing cardiac surgery: the LICRA pragmatic controlled clinical trial. Intensive Care Med. 2017 Jun;43(6):795-806. doi: 10.1007/s00134-017-4772-6. Epub 2017 Mar 25. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |