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HMGB1 Release From Hemorrhagic Shock Patients

Sponsor
Xingui Dai (Other)
Overall Status
Completed
CT.gov ID
NCT03535441
Collaborator
(none)
18
Enrollment
1
Location
11.8
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

It is reported that high mobility group box 1 (HMGB1), a non-histone nuclear protein, can serve as an alarmin with damage associated molecular patterns to activate immune responses in the early stages of hemorrhagic shock (HS). However, the origin of HMGB1 and how it is released following HS is poorly understood. In this study, we teased out this mechanism. We try to record the concentration of serum HMGB1 protein following HS in clinical patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study was approved by the First People's Hospital of Chenzhou, Hunan, P.R. China. Consent was obtained from patients in their hospital course. Eighteen patients were enrolled for each group. In addition, Acute Physiological and Chronic Health Evaluation II (APACHE II) score was used to evaluate the severity and morbidity of HS patients Serial blood samples were collected at indicated time points on hospital admission for HS patients (0, 2, 4, 8, 24, and 72 h following HS). Levels of HMGB1 were detected by ELISA according to the kit manufacturer's instructions.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    18 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Evidence for SIRT1 Mediated HMGB1 Release From Kidney Cells in the Early Stages of Hemorrhagic Shock
    Actual Study Start Date :
    May 17, 2017
    Actual Primary Completion Date :
    Apr 11, 2018
    Actual Study Completion Date :
    May 11, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    voluteer group

    No treatment, only blood sample collection
    hemorrhagic shock group

    HS was defined as out-of-hospital systolic blood pressure (SBP) of 70 mmHg or less or SBP ranging 71 to 90 mmHg with a heart rate of 108 beats/min or more. Exclusion criteria were pregnancy, <15 years old, more than 2,000 mL of intravenous fluids or blood before enrollment, hypothermia, drowning, asphyxia, burns, isolated penetrating head injury, time of call received by dispatch to study intervention longer than 4 h, known prisoners, and transfer from another hospital

    Outcome Measures

    Primary Outcome Measures

    1. serum HMGB1 concentration [24 hours following hemorrhagic shock]

      the concentration of serum HMGB1 were progressively increased following Hemorrhagic shock

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    Hemorrhagic shock (HS) was defined as out-of-hospital systolic blood pressure (SBP) of 70 mmHg or less or SBP ranging 71 to 90 mmHg with a heart rate of 108 beats/min or more.

    Exclusion Criteria:

    pregnancy, <18 years old, more than 2,000 mL of intravenous fluids or blood before enrollment, hypothermia, drowning, asphyxia, burns, isolated penetrating head injury, time of call received by dispatch to study intervention longer than 4 h, known prisoners, and transfer from another hospital

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Hospital of Chenzhou Chenzhou Hunan China 450003

    Sponsors and Collaborators

    • Xingui Dai

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xingui Dai, serum HHMGB1 concentration of hemorrhagic shock patients, First People's Hospital of Chenzhou
    ClinicalTrials.gov Identifier:
    NCT03535441
    Other Study ID Numbers:
    • HSHMGB12018
    First Posted:
    May 24, 2018
    Last Update Posted:
    May 24, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xingui Dai, serum HHMGB1 concentration of hemorrhagic shock patients, First People's Hospital of Chenzhou
    hemorrhagic shock
    HMGB1
    Additional relevant MeSH terms:
    Shock
    Shock, Hemorrhagic

    Study Results

    No Results Posted as of May 24, 2018