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

Sponsor

Peking University First Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05939193

Collaborator

Aerospace Center Hospital (Other)

168

Enrollment

Location

Arms

18.1

Anticipated Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cytoreductive Surgery Hyperthermic Intraperitoneal Chemotherapy Hydration Diuresis Acute Kidney Injury Postoperative Complications	Procedure: Urine-guided hydration Procedure: Routine hydration Drug: Forced administration of furosemide Drug: Routine administration of furosemide	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

168 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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%.	Procedure: 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%. Other Names: Forced administration of furosemide Drug: Forced administration of furosemide Forced administration of furosemide
Active Comparator: 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%.	Procedure: 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%. Other Names: Routine administration of furosemide Drug: Routine administration of furosemide Routine administration of furosemide

Arm

Intervention/Treatment

Experimental: 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%.

Procedure: 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%.

Other Names:

Forced administration of furosemide

Drug: Forced administration of furosemide

Forced administration of furosemide

Active Comparator: 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%.

Procedure: 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%.

Other Names:

Routine administration of furosemide

Drug: Routine administration of furosemide

Routine administration of furosemide

Outcome Measures

Primary Outcome Measures

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

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
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.

Other Outcome Measures

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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.