NCT03410069

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 25, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

August 3, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2019

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

9 months

First QC Date

January 12, 2018

Last Update Submit

May 17, 2019

Conditions

High-risk Surgical Patients

Outcome Measures

Primary Outcomes (1)

  • Incidence of complications

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

    28 days

Secondary Outcomes (12)

  • Applicability of the procedure

    28 days

  • Signal acquisition

    28 days

  • Effect of the position of the sensor

    28 days

  • Quality of the signal

    28 days

  • Evolution of mean arterial pressure

    28 days

  • +7 more secondary outcomes

Study Arms (1)

IKORUS UP

EXPERIMENTAL
Device: IKORUS UP system

Interventions

IKORUS UP systemDEVICE

Continuous assessment of the urethral microcirculation

IKORUS UP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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…).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU Estaing

Clermont-Ferrand, 63003, France

Location

Lyon Sud Hospital

Lyon, 69310, France

Location

Hopital Nord Marseille

Marseille, 13015, France

Location

Hospital Saint Louis

Paris, France

Location

Related Publications (1)

  • Depret F, Leone M, Duclos G, Futier E, Montagne M, Legrand M, Allaouchiche B. Monitoring tissue perfusion: a pilot clinical feasibility and safety study of a urethral photoplethysmography-derived perfusion device in high-risk patients. J Clin Monit Comput. 2020 Oct;34(5):961-969. doi: 10.1007/s10877-019-00414-9. Epub 2019 Nov 6.

    PMID: 31691897DERIVED

Study Officials

  • Bernard Allaouchiche, Prof

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 25, 2018

Study Start

August 3, 2018

Primary Completion

May 7, 2019

Study Completion

May 7, 2019

Last Updated

May 20, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)