Acute Kidney Injury Clinical Trial
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
NCT number | NCT05939193 |
Other study ID # | 2023(080) |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 24, 2023 |
Est. completion date | January 2025 |
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.
Status | Recruiting |
Enrollment | 168 |
Est. completion date | January 2025 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Aerospace Center Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University First Hospital | Aerospace Center Hospital |
China,
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. — View 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. Erratum In: N Engl J Med. 2011 May 19;364(20):1982. — View 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. — View Citation
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. — View 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. — View 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. — View Citation
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incidence of deterioration in renal function | Defined as =1 grade decrease in glomerular filtration rate compared with preoperative value. | Up to 6 months after surgery | |
Other | Recurrence/progress-free survival | Defined as time from surgery to pseudomyxoma peritonei recurrence/progress/metastasis or all-cause death, whichever occurs first. | Up to 6 months after surgery | |
Other | Event-free survival | 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. | Up to 6 months after surgery | |
Primary | 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 | Classification of AKI within 7 days after surgery | AKI is classified according to the KDIGO criteria. | Up to 7 days after surgery | |
Secondary | Intensive care unit (ICU) admission after surgery | ICU admission after surgery | Up to 30 days after surgery | |
Secondary | Length of ICU stay after surgery | Length of ICU stay after surgery | Up to 30 days after surgery | |
Secondary | Duration of mechanical ventilation after surgery | Duration of mechanical ventilation after surgery | Up to 30 days after surgery | |
Secondary | Length of hospital stay after surgery | Length of hospital stay after surgery | Up to 30 days after surgery | |
Secondary | Incidence of other organ injuries within 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. | Up to 7 days after surgery | |
Secondary | All-cause 30-day mortality | All-cause 30-day mortality | Up to 30 days after surgery | |
Secondary | Incidence of postoperative major complications | 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. | Up to 30 days after surgery |
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