NCT02277977

Brief Summary

Microcirculatory disorders play a central role in the pathogenesis of sepsis and septic shock. Without adequate therapy that may lead to multi-organ failure and death. Therefore useful therapeutic measures aim to improve the microcirculation, to avoid tissue hypoxia and thus multiple organ failure or death. Clinically, the microcirculation can currently be indirectly evaluated using the diuresis and metabolic parameters (eg, lactate). The aim of the present study is to measure the microcirculation in septic shock by means of contrast-enhanced sonography of the calf muscles. For this purpose, the method is applied to 24 subjects during and after septic shock. It will be investigated in this study whether the microcirculation measurement with ultrasound contrast reflects the severity of the disease. As well as to evaluate whether the use of this diagnostic method could lead to better treatment of the septic shock.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable sepsis

Status
withdrawn

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

October 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 2, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

October 27, 2014

Last Update Submit

August 30, 2022

Conditions

Sepsis

Keywords

sepsisseptic shockcontrast-enhanced ultrasoundmicrocirculation

Outcome Measures

Primary Outcomes (1)

  • Contrast transit time during and after septic shock

    24 months

Study Arms (1)

Contrast enhanced ultrasound

EXPERIMENTAL

Contrast enhanced ultrasound during septic shock

Other: Contrast enhanced ultrasound

Interventions

Contrast enhanced ultrasoundOTHER

Contrat enhanced ultrasound during septic shock

Contrast enhanced ultrasound

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • septic shock

You may not qualify if:

  • myocardial infarction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Daniel Duerschmied, MD, PHD

    University of Freiburg

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ingeborg Landerer, Clinical Trials Unit

Study Record Dates

First Submitted

October 27, 2014

First Posted

October 29, 2014

Study Start

November 1, 2014

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

September 2, 2022

Record last verified: 2022-08