Risk of Acute Kidney Injury in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy

NCT04941625 | Unknown

• 1 other identifier: 201701400A3
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Establish a HIPEC cohort database, including retrospective data and prospective database
2. 2.Identify the incidence of AKI after HIPEC and the severity
3. 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.
4. 4.Patients with the peritoneal carcinomatosis, planning to receive HIPEC and agree to participate the study will be recruited.
5. 5.Retrospective analyze the renal prognosis of patients with HIPEC procedure and identify the clinical and biochemistry risk factors of HIPEC-related AKI
6. 6.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.
7. 7.Peri-operative dehydration and cisplatin-based regimen are the major risk factors to cause AKI.
8. 8.The novel biomarker, high peri-operative urine NGAL and serum cystatin C, β2 Microglobulin are the predictive markers of HIPEC- related AKI.

Conditions

Acute Kidney Injury

Keywords

Peritoneal malignancy; hyperthermic intraperitoneal chemotherapy; acute kidney injury; renal insufficiency

Outcome Measures

Primary Outcomes (1)

• acute kidney injury

  RIFLE criteria

  1 week

Study Arms (2)

non-AKI

patients do not have post-HIPEC AKI

Diagnostic Test: serum cystatin C; Diagnostic Test: serum beta-microglubulin; Diagnostic Test: urine

AKI

patients have post-HIPEC AKI

Diagnostic Test: serum cystatin C; Diagnostic Test: serum beta-microglubulin; Diagnostic Test: urine

Interventions

serum cystatin C DIAGNOSTIC_TEST

blood sampling

AKI; non-AKI

serum beta-microglubulin DIAGNOSTIC_TEST

blood sampling

AKI; non-AKI

urine DIAGNOSTIC_TEST

neutrophil gelatinase-associated lipocalin

AKI; non-AKI

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receive HIPEC treatment

You may qualify if:

• Patients receive HIPEC treatment
• Age \>20 y/o, \< 75 y/o

You may not qualify if:

• baseline creatinine \>1.5 or GFR \< 50
• AST, ALT, bilirubin \> 3x normal upper limit
• one kidney or previous renal surgery

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital, Chiayi

Taipei, 613, Taiwan

RECRUITING

Related Publications (8)

• 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

• Ihemelandu 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 BACKGROUND

• Schiffl 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 BACKGROUND

• Sin 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 BACKGROUND

• Sugarbaker 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 BACKGROUND

• Verwaal 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 BACKGROUND

• Wang TY, Chen CY, Lu CH, Chen MC, Lee LW, Huang TH, Hsieh MC, Chen CJ, Yu CM, Chuang HC, Liao TT, Tseng CW, Huang WS. Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for peritoneal malignancy: preliminary results of a multi-disciplinary teamwork model in Asia. Int J Hyperthermia. 2018 May;34(3):328-335. doi: 10.1080/02656736.2017.1337238. Epub 2017 Jun 23.

  PMID: 28562119 BACKGROUND

• Yan TD, Stuart OA, Yoo D, Sugarbaker PH. Perioperative intraperitoneal chemotherapy for peritoneal surface malignancy. J Transl Med. 2006 Apr 10;4:17. doi: 10.1186/1479-5876-4-17.

  PMID: 16606461 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples were evaluated using standard laboratory methods. The serum-cystatin C concentration and urine-NGAL in non-AKI and AKI groups are measured pre-operative day, post-operative 2h, 24h, 48h, 72h and day 7.

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency

Interventions

Urination

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Chao-Yu Chen, MD

  Chang Gung Memorial Hospital, Chiayi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao-Yu Chen, MD

CONTACT

+88653621000; b9002031@cgmh.org.tw

Feng-Chi Lung, Bachelor

CONTACT

+88653621000; fengchi1989@cgmh.org.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: June 28, 2021
• Study Start: February 23, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)