An observational study in Sepsis and Septic Shock, sponsored by Zhongda Hospital. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-06.
Sponsored by Zhongda Hospital · Observational
Objective: To investigate the correlation between plasma levels of DDX17 and GSDMD with vascular endothelial dysfunction and prognosis of in sepsis patients.
Design: A single center, prospective, observational research. Participants: Patients with sepsis who are hospitalized to Southeast University Affiliated Zhongda Hospital and meet the diagnostic criteria for sepsis 3.0.
Inclusion criteria:1. There is a potential or clear infection; 2. Sequential organ failure score (SOFA score) increases by more than or equal to 2 points compared to the baseline value; 3. Sign informed consent form.
Exclusion criteria: Age\<18 years old or>80 years old, pregnant women, tumor patients, including diseases that may be complicated with vascular endothelial damage: hypertension, acute and chronic hepatitis (hepatitis caused by virus), liver cirrhosis, PT prolongation after liver transplantation, acute myocardial infarction, chronic tubular nephritis, chronic renal insufficiency/maintenance hemodialysis, renal transplantation, interstitial pneumonia, acute pancreatitis, active phase of systemic lupus erythematosus Ulcerative colitis, Crohn's disease, HELLP syndrome.
Primary outcome: 28-day mortality. Secondary outcome: Plasma levels of DDX17 and GSDMD, and their correlation with vascular endothelial injury, severity, and prognosis in sepsis patients.
Data collection:Recording the population information, including name, sex, BMI, and past history. Recording disease-related information's, including diagnosis, infection site, pathogens, organ dysfunction, SOFA and APACHE II scores. Recording treatment measures of patients, including whether to use vasopressor, invasive mechanical ventilation, and continuous renal replacement therapy. Recording laboratory examination results, including leukocyte count, PCT and hs-CRP on D1, D3 and D7, respectively. All patients were followed up to 28 days. Patients were distributed to survival group and non-survival group according to the 28-day survival.
Sample collection: 3 mL of the patient's peripheral blood were drawn on Day1, 3, and 7, and the plasma was centrifuged and kept at -80 °C. ELISA content detection of DDX17 and GSDMD.
1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.
This study's planned enrollment of 60 is below the median of 160 across 957 observational studies indexed under Sepsis.
Browse Sepsis studies →Zhongda Hospital is the lead sponsor of 103 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with sepsis who are hospitalized to Southeast University Affiliated Zhongda Hospital and meet the diagnostic criteria for sepsis 3.0.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
28-day mortality
Time frame: 28 days
correlation between plasma level of DDX17 and vascular endothelial injury, severity, and prognosis in sepsis patients
Time frame: 28 days
correlation between plasma level of GSDMD and vascular endothelial injury, severity, and prognosis in sepsis patients
Time frame: 28 days
No study locations are listed for this record.
Start is estimated for Sep 2023; primary completion for Dec 2025, 27 months later.
Of 408 non-industry observational studies under Sepsis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 60. This study's planned 27 months is close to that.
Counting every sponsor, half of 452 studies reached it within 29 months; a quarter within 12 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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