NCT03655899

Brief Summary

This study will investigate the metabolic alterations of vascular cells caused by sepsis and septic shock

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

October 23, 2017

Completed
10 months until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2019

Completed
Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

1.4 years

First QC Date

September 26, 2017

Last Update Submit

September 10, 2019

Conditions

Keywords

metabolomicssystems biologySepsis

Outcome Measures

Primary Outcomes (1)

  • Shock induced endotheliopaty

    Mortality

    Up to 30 days

Eligibility Criteria

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

Patients with sepsis or septic shock

You may qualify if:

  • year or older
  • Sepsis or Septic shock

You may not qualify if:

  • Pregnant or breastfeeding
  • Hemoglobin ≤ 5.0 mmol/L
  • Platelets ≤ 5.0 mia/L
  • Consent not obtainable
  • Do not resuscitate order

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Copenhagen NV, DK-2400, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Red blood cells, white blood cells, platelets, plasma

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pär Johansson

    Rigshospitalet, Dept. of Clinical Immunology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 26, 2017

First Posted

August 31, 2018

Study Start

October 23, 2017

Primary Completion

March 12, 2019

Study Completion

March 12, 2019

Last Updated

September 12, 2019

Record last verified: 2019-09

Locations