Study for Rapid Diagnosis of Postoperative Abdominal Infection

Abdominal Surgery Clinical Trial

Official title:

Establishment and Research for Rapid Diagnosis of Postoperative Abdominal Infection Based on Metagenomic Sequencing

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05187871
• Other study ID #: SRDPAI
• Status: Active, not recruiting
• Start date: August 10, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2021
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective and exploratory study, which utilizes non-targeted metagenomic next-generation sequencing (mNGS) detecting drain fluid from patients who are suspected of postoperative abdominal infection. This study aims to explore the clinical value of mNGS in the rapid diagnosis of postoperative abdominal infection, to refine the pathogenic bacteria spectrum, and to establish a novel procedure for postoperative abdominal infection diagnosis.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients who receive abdominal operations with routinely abdominal drainage placement.

2. Abdominal infection is suspected by the clinicians, and one of the following

conditions is met:

1. Temperature =38?;

2. One of the following laboratory indicators: WBC=10×10^9/L, PCT=0.5ng/ml, hsCRP=100mg/L.

Exclusion Criteria:

1. Patients who are diagnosed with the abdominal infection before surgery.

2. Evidence of non-abdominal infection is clear and could explain the clinical symptoms.

Related Conditions & MeSH terms

• Abdominal Surgery
• Communicable Diseases
• Infections
• Intra-abdominal Infection
• Intraabdominal Infections
• Postoperative Fever
• Postoperative Infection

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pathogenic spectrum of postoperative abdominal infection		Through study completion, an average of 1 year
Secondary	Consistency between mNGS and conventional culture methods		Through study completion, an average of 1 year