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

NCT04941625 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2021-06-28

No results posted yet for this study

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. 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

Interventions

DIAGNOSTIC_TEST

serum cystatin C

blood sampling

DIAGNOSTIC_TEST

serum beta-microglubulin

blood sampling

DIAGNOSTIC_TEST

urine

neutrophil gelatinase-associated lipocalin

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Chao-Yu Chen, MD · Chang Gung Memorial Hospital, Chiayi

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-23
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04941625 on ClinicalTrials.gov