Microcirculatory Alterations in Critical Disease: New Ultrasound Technology (SepCease)

September 16, 2020 updated by: St. Olavs Hospital

Microcirculatory Alterations in Critical Disease. New Ultrasound Technology for Assessment of Small-vessel Circulation Pathophysiology

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Critical disease, e.g. life threatening septic shock triggered from infections with multiorgan failure, demands aggressive medical treatment in specialized intensive care units (ICU). Incidences and mortality of sepsis vary significant, depending on regional medical culture, diagnostic criteria and the time span and method of data collection.

Common clinical appearance of critical disease is often life threatening low blood pressure, impaired consciousness up to coma, abnormal breathing patterns, and then subsequently secondary organ failures which further increases mortality. The influence of these 'macro-haemodynamic symptoms', i.e. physiologic aberrations that can be assessed using standard patient monitoring systems, on the tissue micro-circulation where organ damage and finally cell death occurs, is only indirectly available for assessment. Basically, the coarse therapeutic approach to circulatory shock is to normalize macro-haemodynamic parameters, without any robust method to evaluate and monitor micro-circulatory effects. Thus, following current guidelines and clinical practice, it is sometimes not known for sure, on an individual basis, whether treatment and stabilization measures increase survival chances.

Studies of the microcirculation have been performed using invasive micro-dialysis, direct orthogonal polarization spectral imaging and direct side-stream dark-field microscopy. The wide use of these methods is challenged by the fact that they are very expensive and demand extended operator expertise.

The investigators think there is sufficient evidence to claim that further improvement in early diagnostic and therapy guidance of sepsis, septic shock and other critical disease, depends on increased knowledge of microcirculatory alterations, and widespread affordable technical solutions to detect and monitor the course of sepsis and other critical disease at the microcirculatory level.

At the Norwegian University of Technology and Science (NTNU), Department of Circulation and Medical Imaging (ISB), new ultrasound technology has been developed by Professor Hans Torp, which may offer an operator-independent, affordable and non-invasive method to evaluate microcirculation in humans.

In general, ultrasound is unique in that sense that it facilitates non-invasive imaging of anatomy and physiology. The unique with this new probe is the emittance of ultrasound waves from the whole cross-section of the probe surface.

To describe the expected spectrum of microcirculatory impairment during different stages of sepsis, septic shock and comparable critical disease, firstly US registrations are needed from persons with known normal microcirculation. Then, registrations of normal microcirculation are needed in persons exposed to increasing amounts of circulatory stress. Finally, microcirculatory conditions will be observed in patients with critical septic shock. Thus, firstly healthy volunteers are included, then stabile patients undergoing major planned surgery, and finally patients in critical septic shock demanding advanced intensive care treatment and monitoring.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • St Olavs Hospital, Dept Gastrointestinal Surgery, Dept Thoracic Surgery, Dept Intensive Care Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy volunteers: No disease, no medication, no history of cardiovascular events, no smoking, body mass index (BMI) 20-35 kg/m2, no premature cardiovascular disease among parents.
  • patients scheduled for non-thoracic surgery in general anesthesia: BMI 20-35 kg/m2, surgery scheduled for general anaesthesia/narcosis without any expected complications. Typical candidates: Laparotomy/laparoscopy. Cholecystectomy, adnexectomy, hysterectomy. No disease other than the indication for surgery, no medication other than those needed for the present condition demanding surgery, e.g. antibiotics, pain medicine.
  • scheduled for open-chest cardiac surgery, Age < 60 years, BMI 20-35 kg/m2, no diagnosed peripheral artery disease, no history of cardiovascular events other than those indicating the actual surgery - 'as healthy as possible', meaning no previous cardiac surgery, no cerebral vascular events, no diagnosed peripheral artery disease. These patients mostly have a history of hypertension, diabetes, hypercholesterolaemia, myocardial infarction or at least angina pectoris, as well as the associated medical therapy. Typical candidates: Coronary artery disease patients without other diagnosed vascular disease.
  • septic shock defined as 1) suspected infection, and 2) an acute change in the 'Sequential (Sepsis-Related) Organ Failure Assessment' score (SOFA) of two or more points and serum-lactate acid above 2mmol/l and 3) at least one vasopressor (strong blood-pressure stimulating medical infusion) required to maintain mean blood pressure (MAP) above 65 mmHg, despite adequate fluid resuscitation. Mechanical ventilation ('Respirator'). Advanced invasive haemodynamic monitoring including continuous invasive arterial blood pressure, central venous pressure, pulmonary artery pressure (pulmonary artery catheter/ 'Swan Ganz'), cardiac output and systemic vascular resistance monitoring, as well as circulatory parameters associated with these monitoring systems. Frequent non-invasive cardiac ultrasound - echocardiography ('Echo'). Typical candidates: Critical disease ICU patients with suspected septic shock.

Exclusion Criteria:

  • Healthy volunteers: Pregnancy, age > 40 years or < 20 years, BMI < 20 or BMI > 35, history of cardiovascular disease, diabetes or hypertension or previous/ongoing pharmacological/non-pharmacological therapy for such diseases. Hereditary vascular disease or connective tissue disease. Skin disease suspected to be influenced by or to influence US registrations (skin-probe interactions)
  • non-thoracic surgery: Pregnancy, age > 40 years, BMI < 20 or BMI > 35, smoking, history of cardiovascular disease/events, diabetes or hypertension or previous/ongoing pharmacological/non-pharmacological therapy for such diseases. Hereditary vascular disease or connective tissue disease. Skin disease suspected to be influenced by or to influence US registrations (skin-probe interactions).
  • open-chest cardiac surgery: Pregnancy, age > 60 years, BMI < 20 or BMI > 35, history of open chest cardiac surgery. Hereditary vascular disease or connective tissue disease.
  • septic shock: Pregnancy. History of heart failure and ongoing medical therapy for such disease. Hereditary vascular disease or connective tissue disease. Palliative or proliferated cancer disease. Advanced skin disease complicating performance of the US registrations. Isolated contagious patients and patients isolated due to a pronounced immune-suppressed state of health.
  • General: study equipment or ultrasound registrations are suspected to disturb patient treatment
  • General: consent refused by patient or (in case of septic shock) by family member next to kin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: surgery in general anaesthesia
10 patients. ultrasound for microcirculatory assessment applied.
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.
Experimental: open chest cardiac surgery
10 patients. ultrasound for microcirculatory assessment applied.
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.
Experimental: critical septic shock at ICU
20 patients. ultrasound for microcirculatory assessment applied.
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.
Experimental: healthy volunteers
10 subjects. ultrasound for microcirculatory assessment applied.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pulsatile index
Time Frame: 1 day
(velocity max - velocity min) / mean velocity
1 day
Time-velocity-integral
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Olavs Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Norwegian University of Science and Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Hans Torp, prof, Norwegian University of Science and Technology
  • Principal Investigator: Daniel Bergum, md phd, St. Olavs hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017/908

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Critical Illness

Clinical Trials on ultrasound for microcirculatory assessment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings