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

NCT03895606 | Completed

• 1 other identifier: 3-2019-0016
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

HIPEC

patients undergoing cytoreductive surgery and hyperthermic intraoperative chemotherapy due to carcinomatosis.

Other: Data collection

Interventions

Data collection OTHER

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

HIPEC

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cytoreductive surgery with hyperthermic intraoperative chemotherapy

You may qualify if:

• Patients undergoing cytoreductive surgery with hyperthermic intraoperative chemotherapy

You may not qualify if:

• patients under 19

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severeance Hospital

Seoul, 06273, South Korea

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: March 29, 2019
• Study Start: March 29, 2019
• Primary Completion: March 18, 2020
• Study Completion: March 18, 2020
• Last Updated: August 3, 2020

Record last verified: 2020-07

Locations

KR (1)