Very Old Intensive Care Patients - Perfusion

NCT ID: NCT04169204

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 47 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-19
• Study Completion Date: 2024-05-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Measurement of microcirculation

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).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• ≥ 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

Exclusion Criteria

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

• Minimum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 39463395 (View on PubMed)

Other Identifiers

19-021

Identifier Type: -

Identifier Source: org_study_id