Patients Undergoing Cardiothoracic Surgery
Conditions
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
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.
Sponsors
Study design
Intervention model description
Investigator-initiated, prospective, open-label, 4-period sequential study
Eligibility
Inclusion criteria
All adult patients undergoing surgery by Division of cardiothoracic surgery
Exclusion criteria
Nil
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak ∆ serum creatinine | 5 days postoperatively | Maximum change in serum creatinine from baseline |
| AKI ≥stage2 | 5 days postoperatively | AKI, ≥stage2, defined by creatinine-based KDIGO criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Length of stay | On discharge from hospital (7-30 days) | Hospital Length of stay |
| Time to first extubation | On discharge from hospital (7-30 days) | Time to first extubation |
| Individual stages of AKI | 7 days | Individual stages of AKI, defined by creatinine-based KDIGO criteria |
| Mortality | On discharge from hospital (7-30 days) | Mortality |
| Red cell transfusion requirement | Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first | Volume of packed red blood cells transfused |
| Fresh frozen plasma transfusion requirement | Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first | Volume of fresh frozen plasma transfused |
| Platelet transfusion requirement | Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first | Volume of platelets transfused |
| Cryoprecipitate transfusion requirement | Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first | Volume of cryoprecipitate transfused |
| Renal replacement therapy | On discharge from hospital (7-30 days) | Renal replacement therapy |
| ICU Length of stay | On discharge from hospital (7-30 days) | ICU Length of stay |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hyperchloremia | On discharge from hospital (7-30 days) | Incidence of hyperchloremia (SCl- \>110 mmol/L) |
| Incidence of hypochloremia | On discharge from hospital (7-30 days) | Incidence of hypochloremia (SCl- \<96 mmol/L) |
| Incidence of acidemia | On discharge from hospital (7-30 days) | Incidence of acidemia (pH \<7.3) |
| Incidence of alkalemia | On discharge from hospital (7-30 days) | Incidence of alkalemia (pH \>7.5) |
| Incidence of hypernatremia | On discharge from hospital (7-30 days) | Incidence of hypernatremia (SNa+ \>150 mmol/L) |
| Incidence of hyponatremia | On discharge from hospital (7-30 days) | Incidence of hyponatremia (SNa+ \<130 mmol/L) |
| Time-weighted mean serum chloride concentration | First 5 days and through ICU admission | A time-weighted calculation of mean serum chloride concentration |
Countries
Australia