Effect of Urine-guided Hydration on Acute Kidney Injury After CRS-HIPEC

Not Applicable

Completed

• Conditions: Cytoreductive Surgery; Hyperthermic Intraperitoneal Chemotherapy; Hydration; Diuresis; Acute Kidney Injury; Postoperative Complications
• Interventions: Procedure: Routine hydration; Procedure: Urine-guided hydration; Drug: Forced administration of furosemide; Drug: Routine administration of furosemide

• Registration Number: NCT05939193
• Lead Sponsor: Peking University First Hospital

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.

Study Timeline

• Study First Submitted: 2023-07-02
• Study First Submitted QC: 2023-07-10
• Study First Posted: 2023-07-11
• Study Start: 2023-07-24
• Primary Completion: 2024-07-19
• Study Completion: 2025-02-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-15
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Urine-guided hydration	Forced administration of furosemide	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%.
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%.
Routine hydration	Routine administration of furosemide	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%.
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%.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Length of ICU stay after surgery	Up to 30 days after surgery	Length of ICU stay after surgery
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
Duration of mechanical ventilation after surgery	Up to 30 days after surgery	Duration of mechanical ventilation after surgery
Length of hospital stay after surgery	Up to 30 days after surgery	Length of hospital stay 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.

Trial Locations

Locations (1)

Aerospace Center Hospital; 🇨🇳 Beijing, China