Effect of Urine-guided Intraoperative Hydration on the Incidence of Postoperative Acute Kidney Injury and Long-term Outcomes in Patients With Pseudomyxoma Peritonei Receiving CRS-HIPEC: a Prospective, Randomized, Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Urine-guided hydration
- Conditions
- Cytoreductive Surgery
- Sponsor
- Peking University First Hospital
- Enrollment
- 168
- Locations
- 1
- Primary Endpoint
- Incidence of acute kidney injury (AKI) within 7 days after surgery
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Dong-Xin Wang
Professor and Chairman, Department of Anaesthesiology
Peking University First Hospital
Eligibility Criteria
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.
Arms & Interventions
Urine-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 the urine output does not reach the target value, furosemide will be continuously infused at 10 mg/h until the end of the surgery as needed, with a maximum cumulative dose not exceeding 250 mg. Intravenous hydration is performed to balance urine output and to maintain the SVV≤10%.
Intervention: Urine-guided hydration
Urine-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 the urine output does not reach the target value, furosemide will be continuously infused at 10 mg/h until the end of the surgery as needed, with a maximum cumulative dose not exceeding 250 mg. Intravenous hydration is performed to balance urine output and to maintain the SVV≤10%.
Intervention: Forced administration of furosemide
Routine hydration
The target is to maintain urine output at 0.5 ml/kg/h or higher as per current medical practice. That is, furosemide is only administered when clinically necessary or at the discretion of attending anesthesiologists. Intravenous hydration is performed to maintain the SVV≤10%.
Intervention: Routine hydration
Routine hydration
The target is to maintain urine output at 0.5 ml/kg/h or higher as per current medical practice. That is, furosemide is only administered when clinically necessary or at the discretion of attending anesthesiologists. Intravenous hydration is performed to maintain the SVV≤10%.
Intervention: Routine administration of furosemide
Outcomes
Primary Outcomes
Incidence of acute kidney injury (AKI) within 7 days after surgery
Time Frame: Up to 7 days after surgery
Acute kidney injury (AKI) is diagnosed according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
Secondary Outcomes
- Length of ICU stay after surgery(Up to 30 days after surgery)
- Classification of AKI within 7 days after surgery(Up to 7 days after surgery)
- Intensive care unit (ICU) admission after surgery(Up to 30 days after surgery)
- Duration of mechanical ventilation after surgery(Up to 30 days after surgery)
- Length of hospital stay after surgery(Up to 30 days after surgery)
- Incidence of other organ injuries within 7 days after surgery(Up to 7 days after surgery)
- All-cause 30-day mortality(Up to 30 days after surgery)
- Incidence of postoperative major complications(Up to 30 days after surgery)