NCT03289312

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 11, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

December 27, 2017

Status Verified

September 1, 2017

Enrollment Period

11 months

First QC Date

September 18, 2017

Last Update Submit

December 26, 2017

Conditions

Sepsis

Keywords

sepsis, lymphocyte

Outcome Measures

Primary Outcomes (1)

  • lymphocyte loss

    ratios of T cells loss by different mechanism in different subgroups

    day of inclussion and 7th day after inclussion

Secondary Outcomes (2)

  • prognosis

    28-day after inclussion

  • Complicated organ dysfunction

    during 28 days after inclussion

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Health volunteers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ming Xue, MD

CONTACT

08615195971003xueming0304@126.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Southeast University, China

Study Record Dates

First Submitted

September 18, 2017

First Posted

September 20, 2017

Study Start

January 11, 2018

Primary Completion

December 1, 2018

Study Completion

December 31, 2018

Last Updated

December 27, 2017

Record last verified: 2017-09

Locations

CN(1)