Clinical trial · Observational
Risk of Acute Kidney Injury in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) is an emerging surgical procedure for peritoneal carcinomatosis. Despite the survival benefits from HIPEC, complications have been reported with major morbidity and mortality. Acute kidney injury (AKI) is one of the major complications. To date, there is no adequate biomarker to predict the risk of AKI after HIPEC and monitor the renal prognosis after HIPEC-related AKI. Aims: 1. Establish a HIPEC cohort database, including retrospective data and prospective database 2. Identify the incidence of AKI after HIPEC and the severity 3. Identify the biomarker to predictive HIPEC-related AKI and monitor renal prognosis. Understand the risk factors for AKI post- HIPEC helps improve pre-operative patient selection and optimization, facilitate tailoring of chemotherapy, and foster closer peri-operative monitoring and fluid management in at-risk patients. Methods: 1. Patients with the peritoneal carcinomatosis, planning to receive HIPEC and agree to participate the study will be recruited. 2. Retrospective analyze the renal prognosis of patients with HIPEC procedure and identify the clinical and biochemistry risk factors of HIPEC-related AKI 3. Prospective collect the information of patients who are enrolled into this study. The information includes clinical information, biochemistry, electrolyte, and novel biomarkers of body fluids (blood, and urine). The samples of body fluids will be collected on pre-operative day, post-operative 2h, 24h, 48h, 72h and day 7. Patients with or without post-HIPEC AKI will be analyzed. Hypothesis: 1. Peri-operative dehydration and cisplatin-based regimen are the major risk factors to cause AKI. 2. The novel biomarker, high peri-operative urine NGAL and serum cystatin C, β2 Microglobulin are the predictive markers of HIPEC- related AKI.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Kidney Injury | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| serum beta-microglubulin | Diagnostic Test | — | UNRESOLVED |
| serum cystatin C | Diagnostic Test | — | UNRESOLVED |
| urine | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- non-AKI
- description
- patients do not have post-HIPEC AKI
- interventionNames
- Diagnostic Test: serum cystatin C
- Diagnostic Test: serum beta-microglubulin
- Diagnostic Test: urine
- label
- AKI
- description
- patients have post-HIPEC AKI
- interventionNames
- Diagnostic Test: serum cystatin C
- Diagnostic Test: serum beta-microglubulin
- Diagnostic Test: urine
Primary outcomes (1)
- measure
- acute kidney injury
- timeFrame
- 1 week
- description
- RIFLE criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients receive HIPEC treatment 2. Age \>20 y/o, \< 75 y/o Exclusion Criteria: 1. baseline creatinine \>1.5 or GFR \< 50 2. AST, ALT, bilirubin \> 3x normal upper limit 3. one kidney or previous renal surgery
References
Publications (8)
- BACKGROUNDHakeam 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
- BACKGROUNDIhemelandu CU, McQuellon R, Shen P, Stewart JH, Votanopoulos K, Levine EA. Predicting postoperative morbidity following cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CS+HIPEC) with preoperative FACT-C (Functional Assessment of Cancer Therapy) and patient-rated performance status. Ann Surg Oncol. 2013 Oct;20(11):3519-26. doi: 10.1245/s10434-013-3049-8. Epub 2013 Jun 8. PMID 23748607
- BACKGROUNDSchiffl H, Lang SM. Update on biomarkers of acute kidney injury: moving closer to clinical impact? Mol Diagn Ther. 2012 Aug 1;16(4):199-207. doi: 10.1007/BF03262209. PMID 22650449
- BACKGROUNDSin EI, Chia CS, Tan GHC, Soo KC, Teo MC. Acute kidney injury in ovarian cancer patients undergoing cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy. Int J Hyperthermia. 2017 Sep;33(6):690-695. doi: 10.1080/02656736.2017.1293304. Epub 2017 Mar 5. PMID 28540777
- BACKGROUNDSugarbaker PH. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in the management of gastrointestinal cancers with peritoneal metastases: Progress toward a new standard of care. Cancer Treat Rev. 2016 Jul;48:42-9. doi: 10.1016/j.ctrv.2016.06.007. Epub 2016 Jun 16. PMID 27347669
- BACKGROUNDVerwaal VJ, Bruin S, Boot H, van Slooten G, van Tinteren H. 8-year follow-up of randomized trial: cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy in patients with peritoneal carcinomatosis of colorectal cancer. Ann Surg Oncol. 2008 Sep;15(9):2426-32. doi: 10.1245/s10434-008-9966-2. Epub 2008 Jun 3. PMID 18521686