The COVID19 disease in Very Elderly Intensive care Patients (COVIP) study


The first part of the recruitment period ended May 26th, but the study and patient recruitment continues (you can still register your ICU).

Please enter all data you have for patients included until and on May 26th soon.

Please enter their 30-day survival status no later than June 26th.
Please enter their 3-month survival status and EQ5-5D-5L questionnarie no later than August 26th.

Patient recruitment continues throughout the summer and fall so please continue to recruit in your ICU or being recruiting if you have recently joind the study. Thanks for your efforts!


Background

The coronavirus SARS-CoV-2 is currently affecting millions of people across the world and there is an urgent need to investigate patient characteristics and outcome trajectories. Preliminary reports of critically ill COVID-19 patients in Wuhan (China) and Italy have reported a high risk of death in patients with multimorbidity. Also, very old patients with SARS-CoV-2 infections suffered from high mortality rates (1). It is, however, unclear if age alone is an independent risk factor, or if co-morbiditites and frailty trigger the adverse outcome. During the pandemic, treating and triaging elderly COVID-19 may challenge our health care systems.

In non-COVID-19 elderly patients admitted to the ICU, our European research group (2) found that the co-factors are more important than chronological age itself (3, 4).

In patients with COVID-19, pretreatment with angiotensin-blockers and ACE-inhibitors (5) and nonsteroidal anti-inflammatory drugs such as ibuprofen (6) were suggested to be associated with adverse outcome. Furthermore, some groups have reported a higher death rate in patients with concomitant cardiovascular disease (7) and diabetes (8).

This international, multicenter study group (VIP-network) which has previously (2016-2019) conducted the most extensive prospective studies (VIP1VIP2) on elderly ICU patients will conduct a prospective, observational study to examine the relationship between age, co-morbidities, pretreatment frailty and outcomes in a group of elderly patients receiving critical care for COVID-19.

The results will be essential to understand which factors can predict mortality in elderly COVID-19 patients to help to detect these patients early. Furthermore, this study will also be a knowledge base necessary to guide triage decisions in the future. With this pandemic likely to continue for 18 months, it is paramount to identify independent risk factors early to facilitate both risk stratification and substantiate necessary triage decisions. The pandemic begins in many countries worldwide now, and a decisive action of the research community is needed.

The study is endorsed by The European Intensive Care Society (ESICM), can be followed on ResearchGate and is registered on ClinicalTrials.gov (NCT04321265).


Documents

Case record form: Download

Protocol: Download

FAQ: Download


Questions and answers

What is the most important rule for patient registration?
Every patient should only be registered only once in the database, regardless of readmission, transfer or anything else.

How to handle re-admissions in the same hospital?
The patient is once in the database. Readmission to the ICU or transfer to another ICU will be summed up within one CRF/eCRF.

How should time values / time points be recorded in re-admitted patients?
The reference point is always the day of first admission to an ICU. This is the reference for all the other time specifications. A COVID-19-associated re-admission is NOT documented explicitly since this is not possible due to the pragmatic study design. If the readmission is unrelated to COVID-19, the readmission will not be documented.

How to deal with patients who were transferred from another ICU that participates in COVIP?

The most important rule is that patients must only be registered once in the database. If patients are transferred from one ICU to another for capacities and/or ECMO please follow these hints:

  • In general, treat consecutive/connected admissions to two ICUs as one admission.
  • Register across both ICUs as one admission, if possible.
  • The day of admission is the admission day to the first ICU.
  • The duration of treatments and ICU length of stay are cumulated across both ICUs.

How to deal with patients who were transferred from a hospital that does not participate in COVIP?

  • Kindly consider asking the sending hospital/ICU for COVIP-participation.
  • Try to retrieve the relevant information from the documentation of the sending hospital.
  • Try to proceed as recommended in answer 4).
  • If treatment details from the sending ICU cannot be retrieved (initial ABG, SOFA, CFS, durations etc.) documentation should be completed as detailed as possible.

How to deal with patients who are transferred to a hospital/ICU that does not participate in COVIP?

  • Kindly consider asking the receiving hospital/ICU for COVIP-participation.
  • Try to retrieve the relevant information from the documentation of the receiving hospital (e.g. letter of discharge).
  • In any case, retrieve survival outcomes if possible.
  • If treatment details from the receiving ICU cannot ultimately be retrieved (durations etc.) register only treatment details for the sending ICU and/or information as detailed as possible.

How to deal with patients who are re-transferred after the intermediate/temporary treatment in another ICU that does not participate in COVIP?

  • Kindly consider asking the sending ICU for COVIP-participation.
  • Try to retrieve the relevant information from the documentation of the intermediate hospital (e.g. letter of discharge).
  • In any case, retrieve survival outcomes if possible.
  • If treatment details from the sending ICU cannot be ultimately be retrieved (durations etc.) register only details that are available.
  • (some countries can get outcomes from electronic records even though they can’t get treatment details from the receiving ICU).

Is informed consent mandatory for inclusion?
This differs from country to country depending on local law. The principle investigator is located in Germany with mandatory informed consent. However, some countries do not need informed consent. Please follow your local laws and conditions of your local ethical approval strictly. In case there are any questions, your country coordinator is the local expert.

How to define withholding or withdrawing therapy?
Withholding treatment is defined as the decision not to start or escalate a life-sustaining intervention, such as not to perform CPR if a patient had a cardiac arrest or to decide not treat with renal replacement therapy. Withdrawing treatment is defined as a decision to stop a life-sustaining intervention presently being given, such as stopping a norepinephrine infusion knowing that the patient may not survive without the treatment.

I am the study nurse, but only my PI is registered in the database. How can I help to complete the data of my patients?
Each ICU has one login for patient data entry. The ICUs primary local investigator (primary contact) may delegate the task of data entry to someone else at that site. Please ask your primary local investigator for the login credentials.

How is therapy with high-flow nasal cannula (HFNC) coded in the database?
Although different opinions exit about this, HFNC is considered as oxygen therapy without active pressure support in this study. Therefore, is should also NOT be coded as non-invasive mechanical ventilation (NIV).

How is therapy with Continuous Positive Airway Pressure (CPAP) coded in the database?
CPAP therapy as used in obstructive sleep apnea patients is not considered an intervention of intensive care medicine. If this is applied (e.g. in a patient also receiving this treatment outside the ICU) it should NOT be coded as non-invasive mechanical ventilation. Since we do not assess the exact settings of the machine, the decision of considering the treatment as non-invasive mechanical ventilation is left to the treating physician.

What is the patient already has a tracheostomy at ICU admission?
In the CRF please mark “Tracheostomy” = yes and “Start of tracheostomy” = 8888 (se helper note below data entry field).


Country coordinators and steering group


Christian JungPrinciple Investigator of the COVIP study and German coordinatorDusseldorf, Germanychristian . jung @ med . uni-duesseldorf . de
Jesper FjølnerCo-Principle investigator in the COVIP study, Danish coordinator, datamanagerAarhus, Denmarkjespfjoe @ rm . dk
Hans FlaattenPrincipal Investigator of the VIP study group, Past chair HSRO section,Bergen, Norwayhans . flaatten @ uib . no
Antonio ArtigasSpanish coordinatorBarcelona, Spainaartigas @ tauli . cat
Bernardo Bollen PintoSwiss coordinatorGeneva, Switzerlandbernardo . bollenpinto @ hcuge . ch
Bertrand GuidetCo-Principal Investigator of the VIP study group and French coordinatorParis, Francebertrand . guidet @ aphp . fr
Brian MarshIrish coordinatorDublin, Irelandbmarsh @ mater . ie
Dylan deLangeThe Netherlands coordinator and Chair of ESICM HSRO sectionUtrecht, The Netherlandsd . w . delange @ umcutrecht . nl
David DudzinskiUSA coordinatorBoston, Massachusetts , United States of Americaddudzinski @ mgh . harvard . edu
Finn AndersenNorwegian coordinatorÅlesund, Norwayfinn . h . andersen @ helse-mr . no
Michael JoannidisAustrian coordinatorInnsbruck, Austriamichael . joannidis @ i-med . ac . at
Matjaž JerebSlovenia coordinatorLjubljana, Sloveniamatjaz . jereb @ kclj . si
Rokas SerpytisLithuanian coordinatorVilnius, Lithuaniarserpytis @ gmail . com
Muhammed ElhadiLybia, Egypt, Sudan, Algeria, Jordan, Saudi Arabia coordinatorTripoli, Libyamuhammed . elhadi . uot @ gmail . com
Rui MorenoPortuguese coordinatorLisboa, Portugalr . moreno @ mail . telepac . pt
Sigal SviriIsraeli coordinatorJerusalem, Israelsigal . sviri @ gmail . com
Sandra OeyenBelgium coordinatorGhent, Belgiumsandra . oeyen @ ugent . be
Sten WaltherSwedish coordinatorLinkoping, Swedensten . walther @ telia . com
Susannah LeaverUnited Kingdom coodinatorLondon, Englandsusannahleaver @ nhs . net
Tilemachos ZafeiridisGreek coordinatorLarissa, Greecetilemachos @ hotmail . com
Wojciech SzczeklikPolish coordinatorKrakow, Polandwszczeklik @ gmail . com
Yuriy NalapkoUkranian coordinatorLugansk, Ukrainenalapko @ ukr . net
Ariane BoumendilStatisticianParis, Franceariane . boumendil @ gmail . com
Bernhard WernlyCo-Investigator and scientific supportSalzburg, Austriabernhard @ wernly . net
Raphael R. BrunoCo-Investigator and scientific supportDüsseldorf, Germanyraphael . bruno @ med . uni-duesseldorf . de

Scales/scores utilized

Clinical Frailty Scale

The Clinical Frailty Scale (CFS) is a simple point scale with short descriptions and visualizations of levels of frailty. †The CSF is composed of nine classes from very fit to terminally ill. The English version is used for this study.

Clinical Frailty Scale

KATZ ADL

KATZ Activities of daily living

References

  1. Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, et al. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020.
  2. Flaatten H, de Lange DW, Artigas A, Bin D, Moreno R, Christensen S, et al. The status of intensive care medicine research and a future agenda for very old patients in the ICU. Intensive Care Med. 2017;43(9):1319-28.
  3. Flaatten H, De Lange DW, Morandi A, Andersen FH, Artigas A, Bertolini G, et al. The impact of frailty on ICU and 30-day mortality and the level of care in very elderly patients (>/= 80 years). Intensive Care Med. 2017;43(12):1820-8.
  4. Guidet B, de Lange DW, Boumendil A, Leaver S, Watson X, Boulanger C, et al. The contribution of frailty, cognition, activity of daily life and comorbidities on outcome in acutely admitted patients over 80 years in European ICUs: the VIP2 study. Intensive Care Med. 2020;46(1):57-69.
  5. [Available from: https://www.escardio.org/Councils/Council-on-Hypertension-(CHT)/News/position-statement-of-the-esc-council-on-hypertension-on-ace-inhibitors-and-ang.
  6. Day M. Covid-19: ibuprofen should not be used for managing symptoms, say doctors and scientists. BMJ. 2020;368:m1086.
  7. Li B, Yang J, Zhao F, Zhi L, Wang X, Liu L, et al. Prevalence and impact of cardiovascular metabolic diseases on COVID-19 in China. Clin Res Cardiol. 2020.
  8. Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020.