Study on Appropriate Technology of Standardized Diagnosis and Treatment for Diabetic Patients With Pulmonary Infections

NCT03617393 | Unknown

• 1 other identifier: 2017YFC1309700
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

Focusing on patients with diabetes complicated with pulmonary infection, the purpose of this study is: 1) to identify the epidemiology, etiologic spectrum and status of diagnosis and treatment; 2) to develop a symptom score scale , clarify the risk factors and create a precise warning model; 3) to develop a rapid detection of pathogen of lower respiratory infection, to establish clinical pathways of early diagnosis and treatment of diabetes complicated with pulmonary infections (including bacterial, tuberculosis and fungal infections) and then make an application in clinic.

Conditions

Diabetes Mellitus; Pulmonary Infection

Keywords

Early Warning Model; Clinical Pathway; Diabetes; Pulmonary Infection

Outcome Measures

Primary Outcomes (3)

• Survival at 30 Days

  Accuracy and sensitivity of novel survival prediction algorithm derived from differences between the predicted and actual 30-day-survival of patients from different groups.

  30 days from date of diagnosis of pulmonary infection until the date of death from any cause.

• Survival at 90 Days

  Accuracy and sensitivity of novel survival prediction algorithm derived from differences between the predicted and actual 90-day-survival of patients from different groups.

  90 days from date of diagnosis of pulmonary infection until the date of death from any cause.

• Survival at 1 Year

  Accuracy and sensitivity of novel survival prediction algorithm derived from differences between the predicted and actual 1-year-survival of patients from different groups.

  1 year from date of diagnosis of pulmonary infection until the date of death from any cause.

Secondary Outcomes (8)

• Hospitalization Time

  Every 6 months from date of diagnosis of pulmonary infection until the date of death from any cause, assessed up to 3 years

• Sepsis

  Every 6 months from date of diagnosis of pulmonary infection until the date of death from any cause, assessed up to 3 years

• CURB-65 Score

  Every 6 months from date of diagnosis of pulmonary infection until the date of death from any cause, assessed up to 3 years

• Inflammatory Parameters

  Day 0, day 3, day 10-14 and final result from date of diagnosis of pulmonary infection until the date of death or cure from any cause, assessed up to 1 years

• Fungal Infection Examinations

  Day 0, day 3, day 10-14 and final result from date of diagnosis of pulmonary infection until the date of death or cure from any cause, assessed up to 1 years

Study Arms (4)

Pulmonary Infection with DM group

Patients with diabetes and pulmonary infection.

Pulmonary Infection group

Patients with pulmonary infection while the fasting blood-glucose in the normal range.

DM group

Patients without pulmonary infection while the fasting blood-glucose \> 8 mmol/L.

Control group: normal people

Patients without pulmonary infection while the fasting blood-glucose in the normal range.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

diabetes patients complicated with pulmonary infection

You may qualify if:

• Diagnosis by pathogen examination: positive
• Diagnosis through X-ray or CT: characteristic features of pulmonary infection
• Diagnosis through guideline of diabetes or history of diagnosed diabetes
• Age 40-70 years

You may not qualify if:

• Irregular follow-up and lost follow-up
• Withdraw from the study for any reason

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jieming QU, Ph.D., M.D.

  China, Shanghai Ruijin Hospital Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician of Department of Respiratory Medicine

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: August 6, 2018
• Study Start: July 10, 2017
• Primary Completion: May 1, 2019
• Study Completion: December 1, 2021
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)