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

NCT05939193 | Completed

• 1 other identifier: 2023-080
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

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

  Acute kidney injury (AKI) is diagnosed according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria.

  Up to 7 days after surgery

Secondary Outcomes (8)

• Classification of AKI within 7 days after surgery

  Up to 7 days after surgery

• Intensive care unit (ICU) admission after surgery

  Up to 30 days after surgery

• Length of ICU stay after surgery

  Up to 30 days after surgery

• Duration of mechanical ventilation after surgery

  Up to 30 days after surgery

• Length of hospital stay after surgery

  Up to 30 days after surgery

Other Outcomes (3)

• Incidence of deterioration in renal function

  Up to 6 months after surgery

• Recurrence/progress-free survival

  Up to 6 months after surgery

• Event-free survival

  Up to 6 months after surgery

Study Arms (2)

Urine-guided hydration

EXPERIMENTAL

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; Drug: Forced administration of furosemide

Routine hydration

ACTIVE COMPARATOR

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; Drug: Routine administration of furosemide

Interventions

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%.

Also known as: Forced administration of furosemide

Urine-guided hydration

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%.

Also known as: Routine administration of furosemide

Routine hydration

Forced administration of furosemide DRUG

Forced administration of furosemide

Urine-guided hydration

Routine administration of furosemide DRUG

Routine administration of furosemide

Routine hydration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Aerospace Center Hospital: collaborator

Study Sites (1)

Aerospace Center Hospital

Beijing, 100049, China

Location

Related Publications (8)

• 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.

  PMID: 34260006 BACKGROUND

• Angeles MA, Quenet F, Vieille P, Gladieff L, Ruiz J, Picard M, Migliorelli F, Chaltiel L, Martinez-Gomez C, Martinez A, Ferron G. Predictive risk factors of acute kidney injury after cytoreductive surgery and cisplatin-based hyperthermic intra-peritoneal chemotherapy for ovarian peritoneal carcinomatosis. Int J Gynecol Cancer. 2019 Feb;29(2):382-391. doi: 10.1136/ijgc-2018-000099. Epub 2019 Jan 23.

  PMID: 30674567 BACKGROUND

• Hakeam HA, Breakiet M, Azzam A, Nadeem A, Amin T. The incidence of cisplatin nephrotoxicity post hyperthermic intraperitoneal chemotherapy (HIPEC) and cytoreductive surgery. Ren Fail. 2014 Nov;36(10):1486-91. doi: 10.3109/0886022X.2014.949758. Epub 2014 Aug 26.

  PMID: 25155314 BACKGROUND

• Markowiak T, Kerner N, Neu R, Potzger T, Grosser C, Zeman F, Hofmann HS, Ried M. Adequate nephroprotection reduces renal complications after hyperthermic intrathoracic chemotherapy. J Surg Oncol. 2019 Dec;120(7):1220-1226. doi: 10.1002/jso.25726. Epub 2019 Oct 10.

  PMID: 31602673 BACKGROUND

• 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.

  PMID: 31879421 BACKGROUND

• 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.

  PMID: 32912462 BACKGROUND

• 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.

  PMID: 33236105 BACKGROUND

• 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.

  PMID: 19571284 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury; Postoperative Complications

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital, Beijing, CHINA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anaesthesiology

Study Record Dates

• First Submitted: July 2, 2023
• First Posted: July 11, 2023
• Study Start: July 24, 2023
• Primary Completion: July 19, 2024
• Study Completion: February 4, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)