Metabolomic Alterations in the Vascular Compartment in Pa... | NCT03655899

Studies
Metabolomic Alterations in the Vascular Compartment in Patients With Sepsis

NCT03655899

Sponsor

Pär Johansson

Status

Terminated

Last Update Posted

Sep 12, 2019Actual

Enrollment

37Actual

Phase

Not provided

Conditions

Endothelial Dysfunction

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Analysis of cell phenotypes was not possible

Expanded Access Info

Start Date

Oct 23, 2017Actual

Primary Completion Date

Mar 12, 2019Actual

Completion Date

Mar 12, 2019Actual

First Submitted Date

Sep 26, 2017

First Submission Date that Met QC Criteria

Aug 29, 2018

First Posted Date

Aug 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2019

Last Update Posted Date

Sep 12, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

This study will investigate the metabolic alterations of vascular cells caused by sepsis and septic shock in 60 patients

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

37Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Shock induced endotheliopaty	Mortality	Up to 30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 year or older
Sepsis or Septic shock

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with sepsis or septic shock

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pär Johansson	Rigshospitalet, Dept. of Clinical Immunology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bispebjerg Hospital		Copenhagen	Copenhagen NV	DK-2400	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided