Very Old Intensive Care Patients - Perfusion

Intensive Care Clinical Trial

— VIPPER  

Official title:

Very Old Intensive Care Patients - Perfusion (VIPPER)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04169204
• Other study ID #: 19-021
• Status: Active, not recruiting
• Start date: May 19, 2020
• Est. completion date: May 30, 2024

Study information

• Verified date: January 2024
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 47
• Est. completion date: May 30, 2024
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care
• Microcirculation
• Very Old Intensive Care Patients

Intervention

Diagnostic Test:
• 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).

Locations

Country	Name	City	State
Germany	Division of Cardiology, Pulmonary Disease and Vascular Medicine	Duesseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bedside measurement of sublingual microcirculation	measurement of sublingual microcirculation by using MicroScan® microscope	admission of the intensive care unit
Primary	bedside measurement of sublingual microcirculation	measurement of sublingual microcirculation by using MicroScan® microscope	after 24 hours
Secondary	Mortality		after 30 days, 6 months and 12 months
Secondary	Length of stay at ICU		tdays from admission of the intensive care unit until discharge
Secondary	Use of Vasopressors and fluids		days from admission of the intensive care unit until discharge