NCT01976884

Brief Summary

Immunosuppression is the leading cause of death in septic patients. Neutrophils are classical components of innate immunology, but recent studies showed that neutrophils might display antigen presenting function and inhibit lymphocyte proliferation by expressing programmed cell death 1 ligand 1 (PD-L1). Whether neutrophils express PD-L1 and its role in immunosuppression during sepsis remain unclear.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2011

Status
completed

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

Study Start

First participant enrolled

June 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 6, 2013

Completed
Last Updated

November 6, 2013

Status Verified

October 1, 2013

Enrollment Period

1.6 years

First QC Date

October 30, 2013

Last Update Submit

October 30, 2013

Conditions

SepsisImmunosuppression

Keywords

sepsisimmunosuppressionPD-L1

Outcome Measures

Primary Outcomes (1)

  • PD-L1 level on neutrophils

    PD-L1 level on neutrophils was compared between different populations.

    within 24h after recruitment

Secondary Outcomes (1)

  • 28-day mortality

    28 days after diagnosis of sepsis

Study Arms (4)

Severe sepsis

Patients with severe sepsis

Infectious kidney stone

Patients with sepsis after PCNL for infectious kidney stone

Tumor

Patients with pancreatic cancer

Volunteer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted in ICU at Changhai Hospital

You may qualify if:

  • patients with severe sepsis
  • patients with sepsis after PCNL for infectious kidney stone
  • patients with pancreatic cancer
  • healthy volunteers

You may not qualify if:

  • patients with immunodeficient diseases
  • patients who accept glucocorticoid or immunosuppressant
  • patients with an age older than 18 years
  • patients providing the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood sample was collected for detection of neutrophil PD-L1, monocyte HLA-DR and lymphocyte PD-1.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 6, 2013

Study Start

June 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

November 6, 2013

Record last verified: 2013-10