Very Old Intensive Care Patients - Perfusion

NCT04169204 | Unknown

• 1 other identifier: 19-021
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Shock is a frequent, etiologically heterogeneous and often lethal clinical condition of intensive care medicine. This is particularly true for very old intensive care patients (VIPs), who are among the fastest-growing subgroups of all intensive care unit (ICU) patients and who suffer from a significantly impaired outcome. In addition to the treatment of the causes of shock, current therapeutic approaches focus on the stabilization of vital parameters, which in general all reflect macrocirculatory measured values such as blood pressure. In contrast, a disturbance of the microcirculation (blood circulation of the smaller blood vessels \<100 µm) is only poorly measurable and delayed. The last generation of AVA-Software (MicroVisionMedical) will calculate different parameters about the capillary densitiv and perfusion in a user-independent way. VIPPER investigates whether a non-invasive measurement of microcirculation using the sublingual mucosa in very old intensive care patients in shock leads to faster recognition and specific treatment of organ dysfunctions. Secondly, this study checks whether this measurement predicts outcome.

Conditions

Microcirculation; Intensive Care; Very Old Intensive Care Patients

Keywords

Microcirculation; Intensive Care; Critical care; shock; Very Old Intensive Care Patients; risk stratification; SDF-measurement

Outcome Measures

Primary Outcomes (2)

• bedside measurement of sublingual microcirculation

  measurement of sublingual microcirculation by using MicroScan® microscope

  admission of the intensive care unit

• bedside measurement of sublingual microcirculation

  measurement of sublingual microcirculation by using MicroScan® microscope

  after 24 hours

Secondary Outcomes (3)

• Mortality

  after 30 days, 6 months and 12 months

• Length of stay at ICU

  tdays from admission of the intensive care unit until discharge

• Use of Vasopressors and fluids

  days from admission of the intensive care unit until discharge

Interventions

Measurement of microcirculation DIAGNOSTIC_TEST

As a simple clinical test, every patient will receive the assessment capillary refill time and mottling-score. Additionally, repetitive measurements of lactate will be done. The SDF-camera (MicroVision Medical®, Amsterdam, Netherlands) will measure sublingual microcirculation at different time points (Admission and 24h).

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Very Old Intensive Care Patients with shock

You may qualify if:

• ≥ 80 years
• Acute ICU admission
• Shock at the time point of admission to the ICU or in the first 3 hours defined as Lactate ≥ 2 mmol/l AND need for vasoactive substances to maintain a MAP ≥ 65 mmHg in the presence of adequate volume status

You may not qualify if:

• \< 80 years
• Inaccessibility for sublingual measurement
• no informed consent

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

Location

Related Publications (1)

• Bruno RR, Schemmelmann M, Hornemann J, Moecke HME, Demirtas F, Palici L, Marinova R, Kanschik D, Binnebossel S, Spomer A, Guidet B, Leaver S, Flaatten H, Szczeklik W, Mikiewicz M, De Lange DW, Quenard S, Beil M, Kelm M, Jung C. Sublingual microcirculatory assessment on admission independently predicts the outcome of old intensive care patients suffering from shock. Sci Rep. 2024 Oct 27;14(1):25668. doi: 10.1038/s41598-024-77357-y.

  PMID: 39463395 DERIVED

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 19, 2019
• Study Start: May 19, 2020
• Primary Completion: May 31, 2023
• Study Completion: May 30, 2024
• Last Updated: January 9, 2024

Record last verified: 2024-01

Locations

DE (1)