Microcirculatory Alterations in Critical Disease: New Ultrasound Technology

NCT03311568 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-09-18

No results posted yet for this study

Summary

Aim of this study is (1) to test and further develop a new non-invasive ultrasound method, and (2) to gain new insight into microcirculatory alterations during critical disease, particularly in critical septic shock patients.

Although early identification and treatment of sepsis have had top priority among the working tasks of the international 'Surviving Sepsis Campaign' society (collaboration of the Society of Critical Care Medicine and the European Society of Intensive Care Medicine) for several years, which have led to improved survival over the last two decades, there is no objective validated diagnostic test to identify or to support the clinical diagnosis at an early stage. Analogous, there is no validated monitoring system available to guide and evaluate the effects of stabilizing measurements in sepsis, or other critical disease, at the microcirculatory level. And thus, there is an enormous knowledge gap regarding dynamic changes at the microcirculatory level during sepsis and other critical disease.

Goal with this study is to investigate the robustness of this new US-technology, regarding its ability to identify and monitor critical microcirculatory impairment during critical disease. The investigators believe this technology may improve early diagnosis and thus early initiation of adequate treatment in septic shock. Its mobile and non-invasive qualities, as in most ultrasound methods, substantiate its availability to a wide range of clinical settings.

Conditions

  • Critical Illness
  • Septic Shock

Interventions

DEVICE

ultrasound for microcirculatory assessment

Ultrasound for microcirculatory assessment Repeated measurements within study participants for analysis of variance and explorative analyses of ultrasound signals, to identify most suitable parameters to describe microcirculatory alterations in critical disease, especially in sepsis. Analyse blood flow velocities in several depths and from several vessels of different sizes simultaneously US registration repeated within each study participant consecutively on seven different regions of the body surface.

Sponsors & Collaborators

  • Norwegian University of Science and Technology

    collaborator OTHER
  • St. Olavs Hospital

    lead OTHER

Principal Investigators

  • Hans Torp, prof · Norwegian University of Science and Technology

  • Daniel Bergum, md phd · St. Olavs Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2019-11-01
Completion
2019-11-01

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03311568 on ClinicalTrials.gov