Acute Kidney Injury, Cytoreductive Surgery, Diuresis, Hydration, Hyperthermic Intraperitoneal Chemotherapy, Postoperative Complications
Conditions
Keywords
Cytoreductive Surgery, Hyperthermic Intraperitoneal Chemotherapy, Hydration, Diuresis, Acute Kidney Injury, Postoperative Complications
Brief summary
Acute renal injury (AKI) is a common complication after cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC), and is associated with worse outcomes. Available evidences show that maintaining intraoperative urine output ≥ 200 ml/h by fluid and furosemide administration may reduce the incidence of AKI in patients undergoing cardiopulmonary bypass. The investigators hypothesize that, for patients undergoing CRS-HIPEC, intraoperative urine-volume guided hydration may also reduce the incidence of postoperative AKI.
Detailed description
Acute renal injury (AKI) is a common complication after cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC), and is associated with worse outcomes. Studies showed that less intraoperative urine volume was associated with AKI. In studies of contrast-associated AKI, intraoperative and 4-h postoperative hydration and forced diuresis to achieve urine output ≥ 300 ml/h reduces the incidence of AKI by 44%. In patients undergoing cardiac surgery under cardiopulmonary bypass, maintaining intraoperative and 6-h postoperative urine output ≥200 ml/h by fluid and furosemide administration reduces the incidence of AKI by 52%. For patients with rhabdomyolysis, it is recommended to maintain urine output at approximately 3 ml/kg/h (200 ml/h) with volume supplementation. We suppose that forced diuresis with simultaneous hydration (balancing urine output with intravenous fluid infusion) may reduce AKI after CRS-HIPEC. The purpose of this randomised controlled trial is to investigate whether maintaining urine output at 200 ml/h (3 ml/kg/h) or higher by forced diuresis with simultaneous hydration can reduce the incidence of AKI after CRS-HIPEC.
Interventions
PROCEDUREUrine-guided hydration
The target is to maintain urine output at 200 ml/h (3 ml/kg/h) or higher by intravenous injection/infusion of furosemide throughout surgery. That is, a loading dose of 20 mg is injected at the beginning of surgery; if urine output does not reach the target value, furosemide will be continuously infused at 10 mg/h until the end of surgery, with a cumulative dose not exceeding 250 mg. Intravenous rehydration is performed to balance urine output and to maintain the SVV ≤10%.
PROCEDURERoutine hydration
The target is to maintain urine output at 0.5 ml/kg/h or higher according to routine practice. That is, furosemide is only administered when clinically necessary or at discretion of responsible anesthesiologists; intravenous rehydration is performed to maintain the SVV ≤10%.
DRUGForced administration of furosemide
Forced administration of furosemide
DRUGRoutine administration of furosemide
Routine administration of furosemide
Sponsors
Aerospace Center Hospital
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years; * Diagnosed as pseudomyxoma peritonei, scheduled for cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy under general anesthesia; * At least 14 days since the last treatment of chemotherapy, radiotherapy, or immunotherapy; * Consent to participate in this study.
Exclusion criteria
* Persistent preoperative atrial fibrillation, or new-onset cardiovascular event (acute coronary syndrome, stroke, or congestive heart failure) in the past 3 months; * Requirement of vasopressors to maintain blood pressure before surgery; * Known furosemide hypersensitivity; * Chronic kidney disease stage 5 or requirement of renal replacement therapy; * Other conditions that are considered unsuitable for the study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of acute kidney injury (AKI) within 7 days after surgery | Up to 7 days after surgery | Acute kidney injury (AKI) is diagnosed according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of mechanical ventilation after surgery | Up to 30 days after surgery | Duration of mechanical ventilation after surgery |
| Incidence of other organ injuries within 7 days after surgery | Up to 7 days after surgery | Including delirium (assessed with the Confusion Assessment Method \[3D-CAM\] for patients without mechanical ventilation and CAM-ICU for patients with mechanical ventilation\]) within 5 days after surgery, myocardial injury and other organ injuries other than AKI. |
| All-cause 30-day mortality | Up to 30 days after surgery | All-cause 30-day mortality |
| Incidence of postoperative major complications | Up to 30 days after surgery | Postoperative major complications were defined as new-onset conditions that were harmful for patients' recovery and required therapeutic intervention, i.e., grade 2 or higher on Clavien-Dindo classification. |
| Classification of AKI within 7 days after surgery | Up to 7 days after surgery | AKI is classified according to the KDIGO criteria. |
| Intensive care unit (ICU) admission after surgery | Up to 30 days after surgery | ICU admission after surgery |
| Length of ICU stay after surgery | Up to 30 days after surgery | Length of ICU stay after surgery |
| Length of hospital stay after surgery | Up to 30 days after surgery | Length of hospital stay after surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| Event-free survival | Up to 6 months after surgery | Defined as time from surgery to pseudomyxoma peritonei recurrence/progress/metastasis, unplanned re-hospitalization for non-pseudomyxoma peritonei diseases, or all-cause death, whichever occurs first. |
| Recurrence/progress-free survival | Up to 6 months after surgery | Defined as time from surgery to pseudomyxoma peritonei recurrence/progress/metastasis or all-cause death, whichever occurs first. |
| Incidence of deterioration in renal function | Up to 6 months after surgery | Defined as ≥1 grade decrease in glomerular filtration rate compared with preoperative value. |
Countries
China
Outcome results
None listed