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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03535441
Other study ID # HSHMGB12018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 17, 2017
Est. completion date May 11, 2018

Study information

Verified date May 2018
Source First People's Hospital of Chenzhou
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date May 11, 2018
Est. primary completion date April 11, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
China The First Hospital of Chenzhou Chenzhou Hunan

Sponsors (1)

Lead Sponsor Collaborator
Xingui Dai

Country where clinical trial is conducted

China, 

References & Publications (4)

Hwang JS, Choi HS, Ham SA, Yoo T, Lee WJ, Paek KS, Seo HG. Deacetylation-mediated interaction of SIRT1-HMGB1 improves survival in a mouse model of endotoxemia. Sci Rep. 2015 Nov 2;5:15971. doi: 10.1038/srep15971. — View Citation

Hwang JS, Lee WJ, Kang ES, Ham SA, Yoo T, Paek KS, Lim DS, Do JT, Seo HG. Ligand-activated peroxisome proliferator-activated receptor-d and -? inhibit lipopolysaccharide-primed release of high mobility group box 1 through upregulation of SIRT1. Cell Death — View Citation

Rabadi MM, Xavier S, Vasko R, Kaur K, Goligorksy MS, Ratliff BB. High-mobility group box 1 is a novel deacetylation target of Sirtuin1. Kidney Int. 2015 Jan;87(1):95-108. doi: 10.1038/ki.2014.217. Epub 2014 Jun 18. — View Citation

Rickenbacher A, Jang JH, Limani P, Ungethüm U, Lehmann K, Oberkofler CE, Weber A, Graf R, Humar B, Clavien PA. Fasting protects liver from ischemic injury through Sirt1-mediated downregulation of circulating HMGB1 in mice. J Hepatol. 2014 Aug;61(2):301-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary serum HMGB1 concentration the concentration of serum HMGB1 were progressively increased following Hemorrhagic shock 24 hours following hemorrhagic shock
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