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

Sponsor

Gangnam Severance Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03895606

Collaborator

(none)

Enrollment

Location

11.7

Actual Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury Chemotherapy	Other: Data collection

Study Design

Study Type:

Observational

Actual Enrollment :

57 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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

Actual Study Start Date :

Mar 29, 2019

Actual Primary Completion Date :

Mar 18, 2020

Actual Study Completion Date :

Mar 18, 2020

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients undergoing cytoreductive surgery with hyperthermic intraoperative chemotherapy

Exclusion Criteria:

patients under 19

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gangnam Severeance Hospital	Seoul		Korea, Republic of	06273

Sponsors and Collaborators

Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ji-young Kim, Associate professor, Gangnam Severance Hospital

ClinicalTrials.gov Identifier:

NCT03895606

Other Study ID Numbers:

3-2019-0016

First Posted:

Mar 29, 2019

Last Update Posted:

Aug 3, 2020

Last Verified:

Jul 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Acute Kidney Injury

Wounds and Injuries

Study Results

No Results Posted as of Aug 3, 2020