Clinical trial NCT05939193: Effect of Urine-guided Hydration on Acute Kidney Injury After CRS-HIPEC
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cytoreductive Surgery
Hyperthermic Intraperitoneal Chemotherapy
Hydration
Diuresis
Acute Kidney Injury
Postoperative Complications
Keywords: Cytoreductive Surgery
Hyperthermic Intraperitoneal Chemotherapy
Hydration
Diuresis
Acute Kidney Injury
Postoperative Complications
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Aerospace Center Hospital
First posted: 2023-07-11
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Incidence of acute kidney injury (AKI) within 7 days after surgery
timeFrame: Up to 7 days after surgery
Secondary outcomes:
measure: Classification of AKI within 7 days after surgery
timeFrame: Up to 7 days after surgery
measure: Intensive care unit (ICU) admission after surgery
timeFrame: Up to 30 days after surgery
measure: Length of ICU stay after surgery
timeFrame: Up to 30 days after surgery
measure: Duration of mechanical ventilation after surgery
timeFrame: Up to 30 days after surgery
measure: Length of hospital stay after surgery
timeFrame: Up to 30 days after surgery
measure: Incidence of other organ injuries within 7 days after surgery
timeFrame: Up to 7 days after surgery
measure: All-cause 30-day mortality
timeFrame: Up to 30 days after surgery
measure: Incidence of postoperative major complications
timeFrame: Up to 30 days after surgery
Other outcomes:
measure: Incidence of deterioration in renal function
timeFrame: Up to 6 months after surgery
measure: Recurrence/progress-free survival
timeFrame: Up to 6 months after surgery
measure: Event-free survival
timeFrame: Up to 6 months after surgery
Locations:
city: Beijing
country: China
facility: Aerospace Center Hospital
Study officials:
affiliation: Peking University First Hospital, Beijing, CHINA
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liesenfeld LF, Wagner B, Hillebrecht HC, Brune M, Eckert C, Klose J, Schmidt T, Buchler MW, Schneider M. HIPEC-Induced Acute Kidney Injury: A Retrospective Clinical Study and Preclinical Model. Ann Surg Oncol. 2022 Jan;29(1):139-151. doi: 10.1245/s10434-021-10376-5. Epub 2021 Jul 14.
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citation: Solanki SL, Mukherjee S, Agarwal V, Thota RS, Balakrishnan K, Shah SB, Desai N, Garg R, Ambulkar RP, Bhorkar NM, Patro V, Sinukumar S, Venketeswaran MV, Joshi MP, Chikkalingegowda RH, Gottumukkala V, Owusu-Agyemang P, Saklani AP, Mehta SS, Seshadri RA, Bell JC, Bhatnagar S, Divatia JV. Society of Onco-Anaesthesia and Perioperative Care consensus guidelines for perioperative management of patients for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC). Indian J Anaesth. 2019 Dec;63(12):972-987. doi: 10.4103/ija.IJA_765_19. Epub 2019 Dec 11.
citation: Briguori C, D'Amore C, De Micco F, Signore N, Esposito G, Visconti G, Airoldi F, Signoriello G, Focaccio A. Left Ventricular End-Diastolic Pressure Versus Urine Flow Rate-Guided Hydration in Preventing Contrast-Associated Acute Kidney Injury. JACC Cardiovasc Interv. 2020 Sep 14;13(17):2065-2074. doi: 10.1016/j.jcin.2020.04.051.
citation: Luckraz H, Giri R, Wrigley B, Nagarajan K, Senanayake E, Sharman E, Beare L, Nevill A. Reduction in acute kidney injury post cardiac surgery using balanced forced diuresis: a randomized, controlled trial. Eur J Cardiothorac Surg. 2021 Apr 13;59(3):562-569. doi: 10.1093/ejcts/ezaa395.
citation: Bosch X, Poch E, Grau JM. Rhabdomyolysis and acute kidney injury. N Engl J Med. 2009 Jul 2;361(1):62-72. doi: 10.1056/NEJMra0801327. No abstract available.