NCT02605681

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 16, 2015

Completed
12 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2018

Completed
Last Updated

December 12, 2018

Status Verified

December 1, 2018

Enrollment Period

1.4 years

First QC Date

November 12, 2015

Last Update Submit

December 11, 2018

Conditions

Keywords

midkineendothelial injurysepsisangiotensin-converting enzymeangiotensin II

Outcome Measures

Primary Outcomes (1)

  • 28-day mortality

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

    up to 28 days

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who diagnosed for sepsis

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Department of Critical Care Medicine

Nanjing, Jiangsu, 210009, China

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nanjing Zhongda hospital,Southeast University, China

Study Record Dates

First Submitted

November 12, 2015

First Posted

November 16, 2015

Study Start

November 1, 2016

Primary Completion

March 31, 2018

Study Completion

June 15, 2018

Last Updated

December 12, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations