Purpose In the Simple Intensive Care Studies-I (SICS-I), we aim to unravel the value of clinical and haemodynamic variables obtained by physical examination and critical care ultrasound (CCUS) that currently guide daily practice in critically ill patients. We intend to (1) measure all available clinical and haemodynamic variables, (2) train novices in obtaining values for advanced variables based on CCUS in the intensive care unit (ICU) and (3) create an infrastructure for a registry with the flexibility of temporarily incorporating specific (haemodynamic) research questions and variables. The overall purpose is to investigate the diagnostic and prognostic value of clinical and haemodynamic variables.
Participants The SICS-I includes all patients acutely admitted to the ICU of a tertiary teaching hospital in the Netherlands with an ICU stay expected to last beyond 24 hours. Inclusion started on 27 March 2015.
Findings to date On 31 December 2016, 791 eligible patients fulfilled our inclusion criteria of whom 704 were included. So far 11 substudies with additional variables have been designed, of which six were feasible to implement in the basic study, and two are planned and awaiting initiation. All researchers received focused training for obtaining specific CCUS images. An independent Core laboratory judged that 632 patients had CCUS images of sufficient quality.
Future plans We intend to optimise the set of variables for assessment of the haemodynamic status of the critically ill patient used for guiding diagnostics, prognosis and interventions. Repeated evaluations of these sets of variables are needed for continuous improvement of the diagnostic and prognostic models. Future plans include: (1) more advanced imaging; (2) repeated clinical and haemodynamic measurements; (3) expansion of the registry to other departments or centres; and (4) exploring possibilities of integration of a randomised clinical trial superimposed on the registry.
Study registration number NCT02912624; Pre-results.
- Adult intensive & critical care
- Accident & emergency medicine
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Contributors IvdH and FK created the idea of and supervised the SICS-I study. BH, RJE, GK and RW developed the protocol, created the educational platform and implemented the study. BH and RJE drafted the initial versions of the manuscript, analysed the data and contributed equally to this manuscript. JW, AP, VP and HS were involved in future expansions within an international consortium. All other authors critically reviewed the manuscript and agreed with the final version and findings.
Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient consent The manuscript does not contain any identifiable medical information. For our informed consent procedure, we refer to our manuscript.
Ethics approval Medisch Ethische Toetsingscommissie, University Medical Center Groningen.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Upon completion of our study, anonymised data will be available on reasonable request.
Collaborators R.P. Clement, W. Dieperink, P. van der Harst, D.H. Hilbink, M. Klasen, M. Klaver, T. Kaufmann, T.W.L. Scheeren, L.J. Schokking, V.W. Sikkens.
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