Very Old Intensive Care Patients - Perfusion

Active, not recruiting

• Conditions: Intensive Care; Microcirculation; Very Old Intensive Care Patients

• Registration Number: NCT04169204
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2019-11-18
• Study First Posted: 2019-11-19
• Study Start: 2020-05-19
• Primary Completion: 2023-05-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-09
• Study Completion: 2024-05-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
bedside measurement of sublingual microcirculation	after 24 hours	measurement of sublingual microcirculation by using MicroScan® microscope

Secondary Outcome Measures

Name	Time	Method
Mortality	after 30 days, 6 months and 12 months
Use of Vasopressors and fluids	days from admission of the intensive care unit until discharge
Length of stay at ICU	tdays from admission of the intensive care unit until discharge

Trial Locations

Locations (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine; 🇩🇪 Duesseldorf, Germany