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

Acute Kidney Injury Clinical Trial

— HIPEC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03895606
• Other study ID #: 3-2019-0016
• Status: Completed
• Start date: March 29, 2019
• Est. completion date: March 18, 2020

Study information

• Verified date: July 2020
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 18, 2020
• Est. primary completion date: March 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing cytoreductive surgery with hyperthermic intraoperative chemotherapy

Exclusion Criteria:

• patients under 19

Related Conditions & MeSH terms

• Acute Kidney Injury
• Chemotherapy
• Wounds and Injuries

Intervention

Other:
• Data collection
This study is an observational study collecting perioperative data. There is no intervention regarding this study.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severeance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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