Skip to main content
OpenTrials
Completed

NCT Number: NCT05939193

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Urine-guided hydration

Procedure

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

Routine hydration

Procedure

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

Forced administration of furosemide

Drug

Forced administration of furosemide

Routine administration of furosemide

Drug

Routine administration of furosemide

Primary outcomes

  1. 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

  1. Classification of AKI within 7 days after surgery

    Time frame: Up to 7 days after surgery

    AKI is classified according to the KDIGO criteria.

  2. Intensive care unit (ICU) admission after surgery

    Time frame: Up to 30 days after surgery

    ICU admission after surgery

  3. Length of ICU stay after surgery

    Time frame: Up to 30 days after surgery

    Length of ICU stay after surgery

  4. Duration of mechanical ventilation after surgery

    Time frame: Up to 30 days after surgery

    Duration of mechanical ventilation after surgery

  5. Length of hospital stay after surgery

    Time frame: Up to 30 days after surgery

    Length of hospital stay after surgery

  6. Incidence of other organ injuries within 7 days after surgery

    Time frame: 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.

  7. All-cause 30-day mortality

    Time frame: Up to 30 days after surgery

    All-cause 30-day mortality

  8. Incidence of postoperative major complications

    Time frame: 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 outcomes

  1. Incidence of deterioration in renal function

    Time frame: Up to 6 months after surgery

    Defined as ≥1 grade decrease in glomerular filtration rate compared with preoperative value.

  2. Recurrence/progress-free survival

    Time frame: Up to 6 months after surgery

    Defined as time from surgery to pseudomyxoma peritonei recurrence/progress/metastasis or all-cause death, whichever occurs first.

  3. Event-free survival

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

  • Aerospace Center Hospital

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 11, 2023
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.