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CompletedNCT02605681Updated Dec 12, 2018

Midkine and ACE-Ang II Induced Endothelial Injury in Sepsis

An observational study in Sepsis, sponsored by Southeast University, China. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-12.

Sponsored by Southeast University, China · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
26
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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

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Conditions studied

  • Sepsis

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Keywords

  • midkine
  • endothelial injury
  • sepsis
  • angiotensin-converting enzyme
  • angiotensin II
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In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's enrollment of 26 is below the median of 160 across 931 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Southeast University, China is the lead sponsor of 164 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients who diagnosed for sepsis

Eligibility criteria

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.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
26 participants (actual)
Target follow-up
28 Days
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 28-day mortality

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

    Time frame: up to 28 days

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Study locations

1 site
  • Department of Critical Care Medicine
    Nanjing, Jiangsu 210009, China
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References and documents

Publications

  • Xu JY, Chang W, Sun Q, Peng F, Yang Y. Pulmonary midkine inhibition ameliorates sepsis induced lung injury. J Transl Med. 2021 Feb 27;19(1):91. doi: 10.1186/s12967-021-02755-z. PubMed 33639987 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02605681
Lead sponsor
Southeast University, China
Responsible party
Jingyuan,Xu (Nanjing Zhongda hospital,Southeast University, China, Southeast University, China) — Principal investigator
First posted
Nov 16, 2015
Start date
Nov 1, 2016
Primary completion
Mar 31, 2018
Completion
Jun 15, 2018
Last update
Dec 12, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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