Midkine and ACE-Ang II Induced Endothelial Injury in Sepsis

Sepsis Clinical Trial

Official title:

Plasma Midkine Associated Organ Dysfunction and Vascular Injury in Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02605681
• Other study ID #: 2015ZDSYLL069.0
• Status: Completed
• Start date: November 1, 2016
• Est. completion date: June 15, 2018

Study information

• Verified date: December 2018
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Plasma midkine has reported to be elevated in infection and a regulator of angiotensin-converting enzyme (ACE). We aimed to investigate the plasma midkine in septic patients and its association with 28-day mortality and organ function, and also with plasma ACE and angiotensin II.

Description:

This study showed that Ang II induced endothelial injury in sepsis patients. Midkine has been shown to regulate the renin-angiotensin system and acts in the upstream signaling pathway of angiotensin (ANG) II. The investigators want to access the relationship between midkine level and ACE-Ang II induced endothelial injury in sepsis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 15, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

The inclusive criteria were adult patients (age > 18 years-old and < 80 years-old) diagnosed with sepsis, according the definition of the Surviving Sepsis Campaign (2016)

Exclusive criteria included: 1. age < 18 years-old or > 80 years-old; 2. pregnancy or breastfeeding; 3. malignancy; 4. patients with potentially elevated plasma midkine apart from sepsis including acute myocardial infarction, stroke, limb thrombosis, chronic renal dysfunction (baseline plasma creatine =2 mg/dL), autoimmune diseases and Alzheimer syndrome; 5. patients deceased or discharge from ICU within 24 hours; or, 6. written consents could not be obtained.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Locations

Country	Name	City	State
China	Department of Critical Care Medicine	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day mortality	All the patients were followed-up to 28 days and all-cause mortality was recorded.	up to 28 days