Clinical trial

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

Name

2023(080)

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. 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.

Trial arms

Trial start

2023-07-24

Estimated PCD

2024-07-01

Trial end

2025-01-01

Status

Recruiting

Treatment

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 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%.

Arms:

Urine-guided hydration

Other names:

Forced administration of furosemide

Routine 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%.

Arms:

Routine hydration

Other names:

Routine administration of furosemide

Forced administration of furosemide

Arms:

Urine-guided hydration

Routine administration of furosemide

Arms:

Routine hydration

Size

168

Primary endpoint

Incidence of acute kidney injury (AKI) within 7 days after surgery

Up to 7 days after surgery

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 168, 'type': 'ESTIMATED'}}

Updated at

2023-11-18

1 organization

1 product

6 indications

Organization

Peking University First Hospital

Product

Furosemide

Indication

Cytoreductive Surgery

Indication