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

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

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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy; Acute Kidney Injury
• Intervention / Treatment: Other: Data collection

• Study Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06273
    • Gangnam Severeance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cytoreductive surgery with hyperthermic intraoperative chemotherapy

Description

Inclusion Criteria:

• Patients undergoing cytoreductive surgery with hyperthermic intraoperative chemotherapy

Exclusion Criteria:

• patients under 19

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HIPEC; patients undergoing cytoreductive surgery and hyperthermic intraoperative chemotherapy due to carcinomatosis.	Other: Data collection; This study is an observational study collecting perioperative data. There is no intervention regarding this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients with postoperative acute kidney injury staged by Kidney Disease: Improving Global Outcomes (KDIGO)	Stage 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	during postoperative day 7

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2019
• Primary Completion (Actual): March 18, 2020
• Study Completion (Actual): March 18, 2020

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: March 27, 2019
• First Posted (Actual): March 29, 2019

Study Record Updates

• Last Update Posted (Actual): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: 3-2019-0016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No