Radiomics Markers to Predict Sepsis Induced Acute Respiratory Distress Syndrome

Application of Radiomics as Predicted Marker for Patients With Sepsis Induced Acute Respiratory Distress Syndrome：a Protocol for an Observational Ambispective Cohort Study

Introduction:

Sepsis-induced acute respiratory distress syndrome(SI-ARDS) is a common complication of severe sepsis and is an independent contributor to poor prognosis of patients. It remains a clinical challenge to identify the SI-ARDS early and accurately, which could optimize the treatment strategy and reduce the mortality risk. Radiomics high-dimensional features extracted from CT images offer an insight into microvascular damage of SI-ARDS that are imperceptible to human eyes and aspects of intra-alveolar heterogeneity with potential prognostic relevance.

Methods:

Study design Investigators screened all patients with sepsis and septic shock who are treated in Sun Yat-sen Memorial Hospital, Sun Yat-sen University during the period from 1 May 2015 and 30 May 2022. Patients were recruited retrospectively from May 2015 to April 2021 as discovering group, and prospectively during the period from May 2021 to May 2022 as validation group. Follow-up will conducted until April 2023.

Cohort descriptions and definitions Investigators plan to recruit 160 patients in discovering group, 40 patients in internal validation group, and 100 patients in external validation group. Patients between 18 and 80 years of age with sepsis and septic shock will be screened for eligibility. SI-ARDS is defined by sequential occurrence of the sepsis-3 consensus criteria for sepsis and the Berlin Definition for ARDS. The exclusion criteria are：

1. admission stay <24hours,
2. the presence of end-stage lung disease or long-term oxygen therapy,
3. critically ill patients who have started mechanical ventilation caused by SI-ARDS before admission,
4. a history of lung transplantation and chronic obstructive pulmonary disease,
5. cancer patients not/have received chemotherapy.

Outcome measures In this study, the primary outcome measure was the occurrence rates of acute respiratory distress syndrome(ARDS). It refers to the occurrence of sepsis patients progressed into ARDS.

Secondary outcome measures were as follows:

1.28-day mortality 2.ventilator-free days 3.respiratory failure-free days

Data collection All clinical data were collected by investigators and trained personnel. Each participant's data will be filled in electronic case report forms (CRF) and store online using REDCap (Research Electronic Data Capture).

Discussion:

SI-ARDS is one common severe complication with critically ill sepsis patients, which causes high mortality and poor prognosis. Early ARDS patient(arterial oxygen tension/inspired oxygen fraction [PaO2/FIO2] ≤ 300 mmHg but > 200 mmHg) may not require invasive mechanical ventilation, and is more readily reversible than acute respiratory distress syndrome(ARDS). In this ambispecive cohort study, investigators developed and validated novel nomograms incorporating the radiomics signature and clinical signature to provide an easy-to-use and individualized prediction of SI-ARDS occurrence and severe degree in patients with early stage.

Study Overview

• Status: Recruiting
• Conditions: Early Prediction for Sepsis Induced Acute Lung Injury
• Intervention / Treatment: Diagnostic test: radiomic of chest CT

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: LI LI; Phone Number: 02034071029; Email: lil3@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Contact: LI LI; Phone Number: 02034071029; Email: lil3@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

We plan to recruit 160 patients in discovering group, 40 patients in internal validation, and 100 patients in external validation group. Patients between 18 and 80 years of age with sepsis and septic shock will be screened for eligibility

Description

Inclusion Criteria:

• Clinical diagnosis of sepsis
• Clinical diagnosis of ARDS
• Written informed consent in external validation cohort

Exclusion Criteria:

• admission stay <24hours,
• the presence of end-stage lung disease or long-term oxygen therapy,
• critically ill patients who have started mechanical ventilation caused by SA-ARDS before admission,
• a history of lung transplantation and chronic obstructive pulmonary disease,
• cancer patients not/have received chemotherapy

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Model reconstruction cohort; 160 patients were recruited retrospectively from May 2015 to April 2020 as discovering group.	Diagnostic test: radiomic of chest CT; radiomics as a quantitative imaging method for early detection, risk assessment, and treatment decisions for early predicting sepsis induced acute respiratory distress syndrome.
Internal validation cohort; 40 patients were recruited retrospectively from May 2015 to April 2020 as internal validation group.	Diagnostic test: radiomic of chest CT; radiomics as a quantitative imaging method for early detection, risk assessment, and treatment decisions for early predicting sepsis induced acute respiratory distress syndrome.
External validation cohort; 100 patients will be recruited prospectively during the period from May 2020 to April 2021 as external validation group.	Diagnostic test: radiomic of chest CT; radiomics as a quantitative imaging method for early detection, risk assessment, and treatment decisions for early predicting sepsis induced acute respiratory distress syndrome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurrence rates of acute respiratory distress syndrome(ARDS)	It refers to the occurrence of sepsis patients progressed into ARDS in all patients enrolled into the study	from date of admission until the date of disease progressing to ARDS, assessed up to 28days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality	a cox proportion hazards regression model was used to analysis the survival outcome of patients with sepsis within 28 days according to radiomics characteristics	from date of admission until the date of death from any cause, assessed up to 28days
ventilator-free days	defined as the number of calendar days after initiating ventilator unassisted breathing to day 28 after admission	from date of admission until the date of ventilation or discharge from hospital, assessed up to 28days
respiratory failure-free days	defined as the day without evidence of non-respiratory organ failure	from date of admission until the initiating date of respiratory failure, assessed up to 28days

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2021
• Primary Completion (ANTICIPATED): August 17, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: September 4, 2020
• First Posted (ACTUAL): September 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 14, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: sepsis; deep learning; acute respiratory distress syndrome; prediction model; radiomics
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Wounds and Injuries; Infant, Newborn, Diseases; Infant, Premature, Diseases; Thoracic Injuries; Sepsis; Toxemia; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: SYSEC-KY-KS-2020-122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data in this research can contact lil3@mail.sysu.edu.cn for reasonable requests.

Drug and device information, study documents

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