Overview

This trial is active, not recruiting.

Condition sepsis-induced myocardial injury
Sponsor Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Start date April 2016
End date December 2018
Trial size 100 participants
Trial identifier NCT02835573, XH-16-018

Summary

The purpose of this study is to evaluate the potential diagnostic and prognosis value of circulating microRNAs compared with cTnI for the patients of sepsis-induced myocardial injury at the emergency department (ED) and intensive care unit (ICU).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Patients admitted to the hospital with the diagnosis of Sepsis-induced myocardial injury
Patients admitted to the hospital without the diagnosis of Sepsis-induced myocardial injury

Primary Outcomes

Measure
Diagnostic value of microRNAs evaluate by qPCR in patients of sepsis-induced myocardial injury
time frame: Day 7

Secondary Outcomes

Measure
Prognostic value of microRNAs in patients of sepsis-induced myocardial injury
time frame: 6 months

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: 1. Diagnosis of sepsis:SOFA score increase >=2 at baseline level induced by infection. 2. Suspected myocardial injury,including 1 as follows at least:Low blood pressure or using vasoactive drugs; ECG changes(ST segment changes or pathological Q wave); Troponin elevation(> 0.5 μg/L); BNP elevation(> 4670pg/ml); Echocardiography: cardiac function decline(EF<50%). Exclusion Criteria: 1. Skeletal muscle damage (induced by orthopedics, vascular surgery or trauma surgical disease, surgery); 2. Pregnant and lactating women; 3. Patients with mental disorders; 4. Patients are using other experimental drugs; 5. Refusal to provide informed consent

Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.