NCT06045780

Brief Summary

This study was an ambispective observational cohort study that included sepsis patients hospitalized in the Intensive care unit (ICU) of the Nankai Hospital. All patients met the consensus criteria of sepsis-3. The purpose of this study is to investigate the valuable biomarkers for the severity of sepsis and predictors of 30-day mortality for patients with sepsis.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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 13, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

September 13, 2023

Last Update Submit

July 28, 2024

Conditions

Sepsis

Outcome Measures

Primary Outcomes (2)

  • cAMP-response element binding protein 3, CREB3

    CREB3 levels were measured in the PBMCs of sepsis patients and healthy controls

    Up to Day 28

  • ADP-ribosylation factor 4, ARF4

    ARF4 levels were measured in the PBMCs of sepsis patients and healthy controls

    Up to Day 28

Secondary Outcomes (9)

  • Heme oxygnase-1, HO-1

    Up to Day 28

  • ARF family

    Up to Day 28

  • Oxygenation index

    Up to Day 28

  • Mechanical ventilation days

    Up to Day 28

  • Inflammation biomarkers Inflammation levels

    Up to Day 28

  • +4 more secondary outcomes

Study Arms (2)

Sepsis

disease

Other: nothing

Healthy controls

healthy

Other: nothing

Interventions

nothingOTHER

disease

Healthy controlsSepsis

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Septic patients and healthy controls

You may qualify if:

  • Males or females over the age of 18;
  • Sepsis was diagnosed within 48h which meets SPESIS 3 criteria;
  • Capable of understanding the purpose and risk of the study;
  • Patients or proxy must give written informed consent before any assessment is performed.

You may not qualify if:

  • Pregnancy, lactation or perinatal period;
  • Breast carcinoma;
  • HIV seropositive or Syphilis seropositive;
  • Any clinical-relevant condition that might affect study participation and/or study results;
  • Participation in any other intervention trial;
  • Unwillingness or inability to following the study protocol in the investigators opinion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Nankai Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

Related Publications (1)

  • Fowler AA 3rd, Truwit JD, Hite RD, Morris PE, DeWilde C, Priday A, Fisher B, Thacker LR 2nd, Natarajan R, Brophy DF, Sculthorpe R, Nanchal R, Syed A, Sturgill J, Martin GS, Sevransky J, Kashiouris M, Hamman S, Egan KF, Hastings A, Spencer W, Tench S, Mehkri O, Bindas J, Duggal A, Graf J, Zellner S, Yanny L, McPolin C, Hollrith T, Kramer D, Ojielo C, Damm T, Cassity E, Wieliczko A, Halquist M. Effect of Vitamin C Infusion on Organ Failure and Biomarkers of Inflammation and Vascular Injury in Patients With Sepsis and Severe Acute Respiratory Failure: The CITRIS-ALI Randomized Clinical Trial. JAMA. 2019 Oct 1;322(13):1261-1270. doi: 10.1001/jama.2019.11825.

    PMID: 31573637BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

The peripheral blood mononuclear cells (PBMCs) were acquired from blood by a density gradient centrifugation method (Ficoll Histopaque); peripheral blood of normal subjects and septic cases.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jianbo Yu, MD

    Tianjin Nankai Hospital

    STUDY DIRECTOR

Central Study Contacts

Jianbo Yu, MD

CONTACT

+861534442232330717008@nankai.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 21, 2023

Study Start

September 15, 2023

Primary Completion

September 15, 2024

Study Completion

November 15, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)