Microcirculatory Alterations in Critical Disease: New Ultrasound Technology

NCT03311568 | Terminated

• 1 other identifier: 2017/908
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ultrasonography; Microvessels; Physiopathology; Diagnostic Imaging; Critical Care

Outcome Measures

Primary Outcomes (2)

• Pulsatile index

  (velocity max - velocity min) / mean velocity

  1 day

• Time-velocity-integral

  1 day

Study Arms (4)

surgery in general anaesthesia

EXPERIMENTAL

10 patients. ultrasound for microcirculatory assessment applied.

Device: ultrasound for microcirculatory assessment

open chest cardiac surgery

EXPERIMENTAL

10 patients. ultrasound for microcirculatory assessment applied.

Device: ultrasound for microcirculatory assessment

critical septic shock at ICU

EXPERIMENTAL

20 patients. ultrasound for microcirculatory assessment applied.

Device: ultrasound for microcirculatory assessment

healthy volunteers

EXPERIMENTAL

10 subjects. ultrasound for microcirculatory assessment applied.

Device: ultrasound for microcirculatory assessment

Interventions

ultrasound for microcirculatory assessment DEVICE

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.

critical septic shock at ICU; healthy volunteers; open chest cardiac surgery; surgery in general anaesthesia

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St Olavs Hospital, Dept Gastrointestinal Surgery, Dept Thoracic Surgery, Dept Intensive Care Medicine

Trondheim, Norway

Location

MeSH Terms

Conditions

Critical Illness; Shock, Septic

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Hans Torp, prof

  Norwegian University of Science and Technology

  STUDY CHAIR

• Daniel Bergum, md phd

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective observational study. Validation of a new non-invasive ultrasound device in four controlled categories of study participants.

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 17, 2017
• Study Start: October 31, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: September 18, 2020

Record last verified: 2020-09

Locations

NO (1)