The Effect of rTEM in the Prognosis and Severity of Sepsis Induced ARDS

• Sponsor: Southeast University, China (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06063707
• Collaborator: (none)
• Enrollment: 90
• Anticipated Duration (Months): 11

Study Details

Study Description

Brief Summary

To observe the changes of plasma rTEM levels in patients with sepsis, sepsis induced ARDS, and to explore its clinical significance.

Condition or Disease	Intervention/Treatment	Phase
Sepsis	Other: Taking peripheral blood

Detailed Description

90 patients will be included in this study. Blood samples from these patients in the first day, the third day, were maintained and tested to detect the change of rTEM level. Severity of illness and survival status of every patient were recorded within 28 days. The objective is to observe the changes of plasma rTEM levels in patients with sepsis, sepsis induced ARDS, and to explore its clinical significance.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 90 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Effect of rTEM in the Prognosis and Severity of Sepsis Induced ARDS
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2024
• Anticipated Study Completion Date: Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Survivors Sepsis induced ARDS patients who survived	Other: Taking peripheral blood; Taking peripheral blood of no more than 3ml
Nonsurvivors Sepsis induced ARDS patients who not survived	Other: Taking peripheral blood; Taking peripheral blood of no more than 3ml

Outcome Measures

Primary Outcome Measures

1. Mortality [28 day]

   28day mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Diagnosed as Sepsis 3.0 Patients signing informed consent

Exclusion Criteria:

Pregnant women Patients with tumor、hepatitis、liver cirrhosis、acute myocardial infarction、chronic renal tubular nephritis、interstitial pneumonia、acute pancreatitis、systemic lupus erythenatosus、ulcerative colitis、crohn's disease、HELLP syndrome

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Southeast University, China

Investigators

• Principal Investigator: Jingyuan Xu, M.D., Southeast University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jingyuan,Xu, Principal Investigator, Southeast University, China
• ClinicalTrials.gov Identifier: NCT06063707
• Other Study ID Numbers: 2022ZDSYLL402-P01
• First Posted: Oct 2, 2023
• Last Update Posted: Oct 3, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sepsis; Toxemia

Study Results

No Results Posted as of Oct 3, 2023