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Completed

NCT Number: NCT03410069

Monitoring Tissue Perfusion in Critically Ill or High-risk Surgical Patients

Circulatory shock is defined as an imbalance between oxygen supply and/or impaired oxygen use to maintain organ function. With growing evidence of lack of correlation between macro- and micro-circulation, use of "Whole Body" markers such as blood pressure (BP) or Lactates are often insufficient to assess the severity of the oxygen debt and/or tissue hypoperfusion. Thus, an approach incorporating tissue-perfusion based endpoints would represent a significant step up to guide optimal resuscitation of critically-ill patients and to reduce complications in high-risk surgery.

Current monitoring techniques, that complement systemic hemodynamics by focusing on regional perfusion, still lack the required user-friendliness and/or clinical relevance to be routinely used at bedside. Therefore, assessment of the adequacy of tissue perfusion and oxygenation is suboptimal, and implementation of the above-mentioned approaches of resuscitation is still a challenge.

Urethral perfusion is likely to be early and significantly impaired during low-flow states and thus represents a good "candidate" as a surrogate site to assess the perfusion of visceral organs. Besides, urethral mucosa can be investigated in a less invasive and simpler manner than "deeper" organs. Nowadays, no practical methods or devices are available to monitor perfusion in the pelvic area. Thus, recent development of a new monitoring device of urethral perfusion could fill this need and enable enhanced management of patients in Intensive Care Units (ICU) and Operating Rooms (OR).

The device consists of a modified Foley catheter equipped with a photoplethysmographic sensor: the IKORUS UP probe.

The probe will be used by intensivists or anesthesiologists on high-risk surgical patients, i.e. patients with comorbidities undergoing major vascular, thoracic and/or abdominal surgery.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Estaing, Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or more,
  • Male or female,
  • High-Risk surgical patient,
  • Life expectancy expected to exceed 72 hours,
  • Willing to participate and signed informed consent,
  • Affiliation to the French social security system.

Non inclusion criteria:

  • Pregnant or lactating woman,
  • History of recent urological surgery (bladder surgery, prostate surgery…),
  • Known stricture or "impossible insertion" last hospitalization,
  • Traumatic injury to the lower urinary tract,
  • History of radiotherapy of pelvic or genital area,
  • Genital malformation (Hypospadias…).

Treatment and study plan

IKORUS UP system

Device

Continuous assessment of the urethral microcirculation

Primary outcomes

  1. Incidence of complications

    Time frame: 28 days

    Complications rate: Injury during insertion; Bleeding; Infection; Pain; Discomfort.

Secondary outcomes

  1. Applicability of the procedure

    Time frame: 28 days

    Evaluation of applicability (compared to a standard Foley catheter): questionnaire for the nurse and/or the physician.

  2. Signal acquisition

    Time frame: 28 days

    Duration of useable signal acquisition (duration of perfusion index computation)

  3. Effect of the position of the sensor

    Time frame: 28 days

    Quality of signal according to sensor position (proximal/distal)

  4. Quality of the signal

    Time frame: 28 days

    Assessment of signal Quality, including Signal-to-noise ratio

  5. Evolution of mean arterial pressure

    Time frame: 28 days

    Measures of hemodynamic /metabolic parameters: mean arterial pressure (MAP)

  6. Evolution of SpO2

    Time frame: 28 days

    Measures of hemodynamic /metabolic parameters: SpO2

  7. Evolution of SVO2

    Time frame: 28 days

    Measures of hemodynamic /metabolic parameters: SVO2

  8. Evolution of lactates dosages

    Time frame: 28 days

    Measures of hemodynamic /metabolic parameters: lactactes

  9. Evolution of cardiac outputs

    Time frame: 28 days

    Measures of hemodynamic /metabolic parameters: cardiac output

  10. Evolution of central venous pressure

    Time frame: 28 days

    Measures of hemodynamic /metabolic parameters: central venous pressure (CVP)

  11. Evolution of catecholamine infusions levels

    Time frame: 28 days

    Measures of hemodynamic /metabolic parameters: catecholamine infusions levels

  12. Rate of resuscitation events

    Time frame: 28 days

    Measures of hemodynamic or metabolic parameters: resuscitation events

Sponsors and collaborators

Lead sponsor

Advanced Perfusion Diagnostics

Industry

Collaborators

  • CEISO

Registry information

Official study title

Monitoring Tissue Perfusion in Critically Ill or High-risk Surgical Patients: a Pilot Clinical Study To Evaluate the aPplicability and the Safety of Urethral Perfusion Measurement With the IKORUS System

Acronym: STEP UP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 25, 2018
Registry last updated
May 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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