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

Completed

• Conditions: Acute Kidney Injury; Chemotherapy
• Interventions: Other: Data collection

• Registration Number: NCT03895606
• Lead Sponsor: Gangnam Severance Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-03-27
• Study Start: 2019-03-29
• Study First Posted: 2019-03-29
• Primary Completion: 2020-03-18
• Study Completion: 2020-03-18
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-31
• Last Update Posted: 2020-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Patients undergoing cytoreductive surgery with hyperthermic intraoperative chemotherapy

Exclusion Criteria

• patients under 19

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIPEC	Data collection	patients undergoing cytoreductive surgery and hyperthermic intraoperative chemotherapy due to carcinomatosis.

Primary Outcome Measures

Name	Time	Method
number of patients with postoperative acute kidney injury staged by Kidney Disease: Improving Global Outcomes (KDIGO)	during postoperative day 7	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

Trial Locations

Locations (1)

Gangnam Severeance Hospital; 🇰🇷 Seoul, Korea, Republic of