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Prediction of Kidney Injury After Hyperthermic Intraperitoneal Chemotherapy (HIPEC)* With Machine Learning

Application of Machine Learning to Predict Postoperative Acute Kidney Injury in Patients Undergoing Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy Using High-resolution, Time-synchronized Physiological Data From Vital Recorder

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03895606
Acronym
HIPEC
Enrollment
57
Registered
2019-03-29
Start date
2019-03-29
Completion date
2020-03-18
Last updated
2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Chemotherapy

Brief summary

Patients undergoing cytoreductive surgery with hyperthermic intraoperative chemotherapy (CRS with HIPEC) are prone to postoperative kidney dysfunction. Previous models predicting kidney injury after CRS with HIPEC did not include intraoperative physiologic data. This study is designed to include not only mean arterial pressure but other parameters such as systolic, diastolic arterial pressure, heart rate, oxygen saturation, body temperature, cardiac index, stroke volume variation and many other physical parameters using a data collection system that can record them every 1-7 seconds. The data will be analyzed using machine learning algorithms.

Interventions

OTHERData collection

This study is an observational study collecting perioperative data. There is no intervention regarding this study.

Sponsors

Gangnam Severance Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients undergoing cytoreductive surgery with hyperthermic intraoperative chemotherapy

Exclusion criteria

* patients under 19

Design outcomes

Primary

MeasureTime frameDescription
number of patients with postoperative acute kidney injury staged by Kidney Disease: Improving Global Outcomes (KDIGO)during postoperative day 7Stage 1: Increased sCr × 1.5 to 1.9 baseline or ≥ 0.3 mg/dl from baseline or urine output \< 0.5 ml/kg/h for 6 to 12 h, Stage 2: Increased sCr × 2.0 to 2.9 baseline or urine output \< 0.5 ml/kg/h for 12 h, Stage 3: Increased sCr × 3 baseline or ≥ 4 mg/dl or initiation of RRT, or GFR decrease \< 35 ml/min/1.73 m2 for patients \< 18 years of age or urine output \< 0.3 ml/kg/h for 24 h or anuria for 12 h

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026