NCT03410069: STEP UP

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

Completed NA Last updated 20 May 2019

What this trial tests

NA trial testing IKORUS UP system in High-risk Surgical Patients in 30 participants. Completed in 7 May 2019.

Timeline

3 August 2018

Primary endpoint
7 May 2019

7 May 2019

Quick facts

Lead sponsor	Advanced Perfusion Diagnostics
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	30
Start date	3 August 2018
Primary completion	7 May 2019
Estimated completion	7 May 2019
Sites	4 locations across France

Drugs / interventions tested

• IKORUS UP system

Conditions studied

• High-risk Surgical Patients — all drugs for High-risk Surgical Patients →

Sponsor

Advanced Perfusion Diagnostics

Who can join

18 and older, any sex, with High-risk Surgical Patients. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Monitoring tissue perfusion: a pilot clinical feasibility and safety study of a urethral photoplethysmography-derived perfusion device in high-risk patients.
   Dépret F, Leone M, Duclos G, Futier E, et al · · 2020 · cited 15× · PMID 31691897 · DOI 10.1007/s10877-019-00414-9