Information overview of the VIP2 study (POETICS2 in UK)

VIP2 stands for Very old Intensive Care Patient-study 2: Development and validation of a prognostic score.

An ESICM supported study conducted from the HSRO & NAHP section in ESICM.

Background and scope
This study will seek to develop a prognostic score for specifically very old, critically ill patients  defined as patients ≥ 80 years). This is a large, prospective, multinational, multicentre study. We will gather age-specific information about the elderly patient: frailty, cognitive function, activity of daily life and co-morbidity, in addition to organ failure score. Outcomes will be registered as outcome at 30 days (alive or dead) and 6 months in a sub-study. Also an interrater variability will be registered in a sub-study within the main study.

Recruitment of patients
The goal is to recruit 20 consecutive ICU patients ≥ 80 years, or continue for a 6 months period. Based on a previous multicentre study (the VIP1) we hope to recruit 200-250 ICUs and 4000-5000 patients.

Ethics
We will not register any patient specific identifying information. We will only register gender and age (in rounded years). Each participating country must of course comply to their national rules for such a study. This means that appropriate ethical approval should be sought by national (or local) ethical committees for the need for patient informed consent and sending data to an external server. In some countries this will be (partially) done by the national coordinators (see list).

How to record data?
We use the same dedicated server as in the VIP1-study, which is located at the Department of Clinical Medicine, Aarhus University,Aarhus, Denmark. We have created a simple e-CRF for this study. It will be easy to enter both ICU background data and patient data. All in all, there are 19 different variables to register, some simple (like age) and some more compound like SOFA score. The ICU background data must be collected before start of patient recruitment.

Data security and storage
Data security in the VIP2 study follows recognized industry standards. The data entry forms and database run on a secured server and are composed of a MySQL database and PHP webapplication. Data transfer is secured with Secure Socket Layer (SSL) encryption and data is stored on servers located at Aarhus University, Aarhus C, Denmark. The servers are located in a professional server environment and managed in co-operation between the IT Department and the Department of Clinical Medicine. For technical inquiries please contact the data-manager: Jesper Fjølner, MD. email: contact@vip2study.com.

Study start
Our goal is to open for ICU recruitment from early 2018 and to start inclusion for 6 months. In the meantime, it is important to seek the necessary ethical approval (local/national regulations) for collecting data.