Very Old Intensive Care Patients - Perfusion (VIPPER)

Very Old Intensive Care Patients - Perfusion (VIPPER)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Intensive Care; Microcirculation; Very Old Intensive Care Patients
• Intervention / Treatment: Diagnostic test: Measurement of microcirculation

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

• Study Contact: Name: Christian Jung, MD; Phone Number: 00492118118800; Email: ctsu@med.uni-duesseldorf.de
• Study Contact Backup: Name: Raphael Bruno, MD; Phone Number: 00492118118800; Email: ctsu@med.uni-duesseldorf.de

Study Locations

• Germany
  • Duesseldorf, Germany, 40225
    • Division of Cardiology, Pulmonary Disease and Vascular Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Very Old Intensive Care Patients with shock

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2020
• Primary Completion (Actual): May 31, 2023
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: shock; Critical care; Intensive Care; Microcirculation; risk stratification; Very Old Intensive Care Patients; SDF-measurement
• Other Study ID Numbers: 19-021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No