Midkine and ACE-Ang II Induced Endothelial Injury in Sepsis

Sponsor

Southeast University, China (Other)

Overall Status

Completed

CT.gov ID

NCT02605681

Collaborator

(none)

Enrollment

Location

19.4

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis

Detailed 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

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

26 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Plasma Midkine Associated Organ Dysfunction and Vascular Injury in Sepsis

Actual Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Mar 31, 2018

Actual Study Completion Date :

Jun 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
septic patients We recruited the patients admitted to the Department of Critical Care Medicine, Zhongda Hospital, a tertiary hospital, from November 2017 to March 2018. 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.

Arm

Intervention/Treatment

septic patients

We recruited the patients admitted to the Department of Critical Care Medicine, Zhongda Hospital, a tertiary hospital, from November 2017 to March 2018. 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.

Outcome Measures

Primary Outcome Measures

28-day mortality [up to 28 days]
All the patients were followed-up to 28 days and all-cause mortality was recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.