Effect of Renin-Angiotensin System on Platelet in Patient With Sepsis

NCT03952390 | Completed

• 1 other identifier: XHEC-C-2017-080
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

As a common and serious medical condition , sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection , which is a major and familiar cause of death in intensive care units(ICU). As a frequent laboratory abnormality in patients with sepsis , thrombocytopenia on intensive care unit admission is independently associated with increased mortality in patients. Furthermore, a low platelet count is a marker with further significance , which is always used for evaluating the prognosis of patients. Herein, this study aimed to investigate the effect of renin-angiotensin system on thrombocytopenia in patient with sepsis and explore the possible underlying molecular mechanisms.

Conditions

Sepsis

Keywords

thrombocytopenia,Renin-Angiotensin System,platelet

Outcome Measures

Primary Outcomes (3)

• Platelet Count of Blood Sample

  The platelet count of venous blood samples collected from patients with sepsis was measured by Blood routine instrument,Beckman CoulterLH750.

  20-60min

• The Plasma Renin Activity of Blood Sample

  Venous blood samples were collected in ethylenediaminetetraacetic acid (EDTA),dimercaptopropanol and 8 - hydroxyquinoline sulfate plus blood collection tubes, followed by centrifugation to separate plasma from venous blood samples.The plasma renin activity of venous blood samples collected from patients with sepsis was measured by Iodine\[125I\]AngiotensinⅡRadioimmunoassay Kit.

  20-60min

• The Plasma Concentration of AngiotensinⅡ in Blood Sample

  Venous blood samples were collected in ethylenediaminetetraacetic acid (EDTA) ,dimercaptopropanol and 8 - hydroxyquinoline sulfate plus blood collection tubes, followed by centrifugation to separate plasma from venous blood samples.The plasma concentration of angiotensinⅡ in venous blood samples collected from patients with sepsis was measured by Iodine\[125I\]AngiotensinⅡRadioimmunoassay Kit.

  20-60min

Secondary Outcomes (2)

• Correlation Coefficient (r) Between Platelet Count and The Plasma Renin Activity

  20-60min

• Correlation Coefficient (r) Between Platelet Count and The Plasma Concentration of AngiotensinⅡ

  20-60min

Study Arms (2)

control

healthy volunteers

Other: control

sepsis

patients with sepsis

Other: sepsis

Interventions

control OTHER

Also known as: healthy volunteers

control

sepsis OTHER

Also known as: patients with sepsis

sepsis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with sepsis

You may qualify if:

• Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.
• Organ dysfunction can be identified as an acute change in total SOFA score ≥2 points consequent to the infection.
• The baseline SOFA score can be assumed to be zero in patients not known to have preexisting organ dysfunction.
• ASOFA score ≥2 reflects an overall mortality risk of approximately 10% in a general hospital population with suspected infection. Even patients presenting with modest dysfunction can deteriorate further,emphasizing the seriousness of this condition and the need for prompt and appropriate intervention, if not already being instituted.
• In lay terms, sepsis is a life-threatening condition that arises when the body's response to an infection injures its own tissues and organs.
• Patients with suspected infection who are likely to have a prolonged ICU stay or to die in the hospital can be promptly identified at the bedside with qSOFA, ie, alteration in mental status, systolic blood pressure ≥100 mm Hg, or respiratory rate ≥22/min.
• Septic shock is a subset of sepsis in which underlying circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality.
• Patients with septic shock can be identified with a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level \>2 mmol/L (18mg/dL) despite adequate volume resuscitation. With these criteria,hospital mortality is in excess of 40%.
• Abbreviations: MAP, mean arterial pressure; qSOFA, quick SOFA; SOFA: Sequential\[Sepsis-related\] Organ Failure Assessment.

You may not qualify if:

• Pregnant or lactation period.
• Age \<18 years or \>85 years.
• Receiving chemotherapy, steroid or immunosuppressive agents recently.
• Receiving any drugs that affect Renin-Angiotensin-System(RAS),sunch as Angiotensin Converting Enzyme Inhibitor(ACEI),Angiotensin Receptor Blockers(ARB)，diuretics，calcium channel blockers and other antihypertensives within two weeks .
• Receiving oral contraceptives within twelve weeks.
• Enrollment before resuscitation.

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

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma seperated from venous blood via centrifugation

MeSH Terms

Conditions

Sepsis; Thrombocytopenia

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• Lai Jiang, chief doctor

  Xinhua Hospital affiliated to Medicine school,Shanghai Jiaotong University

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: May 16, 2019
• Study Start: January 1, 2018
• Primary Completion: December 10, 2019
• Study Completion: December 15, 2019
• Last Updated: January 18, 2020

Record last verified: 2018-12

Locations

CN (1)