Effect of R-spondin3 on Sepsis Induced Endothelial Dysfunction

NCT04546919 | Unknown

• 1 other identifier: XHEC-C-2020-084
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Sepsis is the most frequent risk factor for ALI/ARDS. Meanwhile, Pulmonary is the most vulnerable organ to fail in response to sepsis, vascular endothelial dysfunction is a central event in the pathophysiology of sepsis. An improved understanding of endothelial response and associated biomarkers may lead to strategies to more accurately predict outcome and develop novel endothelium-directed therapies in sepsis. The human and mouse R-spondins encode a family of proteins that includes four paralogs (R-spo1-4). R-spondins are secreted proteins found primarily in the extracellular region and are known to promote β-catenin signaling. Among them, the embryonic lethal vascular remodeling phenotype of R-spondin3 (Rspo3) mutant mice suggests a role of EC derived Rspo3 in angiogenesis. Rspo3 protects tissues against mesenteric I/R by tightening endothelial cell junction and improving vascular intergrity. However, the role of Rspo3 in sepsis-induced pulmonary endothelial dysfunction remains unclear. Thus, it is worthwhile to explore the relationship between Rspo3 and sepsis-induced lung injury, which will be helpful for prevention and treatment of sepsis-induced lung injury and endothelial dysfunction.

Conditions

Acute Lung Injury (ALI); Acute Respiratory Distress Syndrome (ARDS)

Keywords

sepsis; Rspondin3; ALI

Outcome Measures

Primary Outcomes (1)

• Change in Plasma Concentration of R-spondin 3

  The venous blood samples were collected from septic patients after the onset of the sepsis, plasma were separated by centrifugation and detected for R-spondin3 concentration.

  after initiation of sepsis within 24 hours

Interventions

sepsis OTHER

Body temperature higher than 38°C or lower than 36°C; Heart rate higher than 90/min; Hyperventilation evidenced by respiratory rate higher than 20/min or PaCO2 lower than 32 mmHg; White blood cell count higher than 12,000 cells/ µl or lower than 4,000/ µl.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

septic patients

You may qualify if:

• patients with sepsis defined as SIRS combined with an infectious episode and dysfunction of one or more organ
• age older than 18 years
• SIRS is considered to be present when patients have more than one of the following clinical findings:
• Body temperature higher than 38°C or lower than 36°C;
• Heart rate higher than 90/min
• Hyperventilation evidenced by respiratory rate higher than 20/min or PaCO2 lower than 32 mmHg;
• White blood cell count higher than 12,000 cells/ µl or lower than 4,000/ µl.

You may not qualify if:

• patients younger than 18
• women during pregnancy or lactation; being involved in other clinical subjects.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Department of Anesthesia, Shanghai Xinhua hospital

Shanghai, Shanghai Municipality, 200082, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

venous blood samples from septic patients

MeSH Terms

Conditions

Acute Lung Injury; Respiratory Distress Syndrome; Sepsis

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lai Jiang, chief doctor

  Xinhua Hospital affiliated to Medicine school,Shanghai Jiaotong University

  STUDY CHAIR

Central Study Contacts

Lai Jiang, chief doctor

CONTACT

+86-2125077821; jianglai@xinhuamed.com.cn

Hui Zhang, resident

CONTACT

+86-2125077821; hui950315@sjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: September 14, 2020
• Study Start: July 8, 2020
• Primary Completion: August 8, 2021
• Study Completion: December 12, 2021
• Last Updated: September 14, 2020

Record last verified: 2020-07

Locations

CN (1)