Dissecting How Peripheral Lymphocytes Are Lost During Sepsis (SLL)

There is an observational, clinical study. We recruit sepsis patients to investigate what drives peripheral lymphocyte loss in sepsis.

Study Overview

• Status: Unknown
• Conditions: Sepsis

Detailed Description

There is an observational, clinical study. We recruit patients with diagnosis of new onset sepsis within 24h, collect and record clinical characteristics：

①Demography data，diagnosis, admission source, infection source, APACHE II,SOFA scores;②Endotoxin levels and PaO2 measured;③Immune and systemic inflammatory indicators：T, RR, WBC, ALC, etc.;④Complicated organs dysfunctions: duration and therapy;⑤Incidence of ICU-acquired infection and prognosis.The blood samples were collected for apoptosis,necrosis,autophagy,pyroptosis measurements.The aim of this study is to investigate how peripheal lymphocyte loss relates to outcome and the mechanisms of peripheal lymphocyte loss in different condition.

• Study Type: Observational
• Enrollment (Anticipated): 54

Contacts and Locations

• Study Contact: Name: Ming Xue, MD; Phone Number: 08615195971003; Email: xueming0304@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Inclusion Criteria:

• Diagnosis of new onset sepsis within 24h.

Exclusion Criteria:

• History of tumor, hematological or immunological disease, and treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization.

Description

Inclusion Criteria:

• Health volunteers

Exclusion Criteria:

• History of tumor, hematological or immunological disease, and treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Sepsis; Diagnosis of new onset sepsis within 24h without history of tumor, hematological or immunological disease, and treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization.
Health control; Health vonlunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lymphocyte loss	ratios of T cells loss by different mechanism in different subgroups	day of inclussion and 7th day after inclussion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prognosis	28-day prognosis:survive or not	28-day after inclussion
Complicated organ dysfunction	duration and surpport therapy	during 28 days after inclussion

Collaborators and Investigators

• Sponsor: Southeast University, China

Study record dates

Study Major Dates

• Study Start (Anticipated): January 11, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: September 18, 2017
• First Posted (Actual): September 20, 2017

Study Record Updates

• Last Update Posted (Actual): December 27, 2017
• Last Update Submitted That Met QC Criteria: December 26, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: sepsis, lymphocyte
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: 2017ZDSYSLLoss

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No