Simple Intensive Care Studies II

NCT03577405 | Completed DMC

• 1 other identifier: 201800246
• Study Type: observational
• Target: 1,010
• Locations: 1 country
• Sites: 1

Brief Summary

Critically ill patients admitted to the intensive care unit (ICU) frequently suffer from circulatory shock or respiratory distress, with high morbidity and mortality up to 40%. After initial fluid resuscitation other complications associated with either treatment or disease may arise. A consequence of treatment might be fluid overload or overfilling. Multiple studies have shown the possible negative effects of - too much - fluid administration, such as venous congestion. Venous congestion entails venous fluid overload, manifested by for example an increased central venous pressure (CVP) or peripheral oedema. This venous congestion may contribute to the occurrence of short-term organ failure by causing a high ''afterload'' in the venous tracts of organs. There is no consensus on how to measure venous congestion. It is important to identify variables that reflect the development of venous congestion in order to investigate whether venous congestion is associated with short-term organ failure. Variables that indicate venous congestion may be obtained with clinical examination and biochemical analyses, supplemented by hemodynamic variables derived from critical care ultrasonography (CCUS) with information about organ perfusion, and both arterial and venous function. The development of short-term organ failure can be assessed by collecting clinical, biochemical and hemodynamic variables at multiple moments. Using repeated measurements is likely to add dynamic information about the diagnostic and prognostic value of these variables. The dynamics of variables, in any direction, over time might improve the diagnostic accuracy and prognostic value of clinical, biochemical and hemodynamic variables that can be collected at the beside of the critically ill patient. Aim and hypotheses This study aims to investigate the association between dynamic variables that reflect venous congestion and the development of short-term organ failure and mortality in the critically ill. The primary objective of this study is to identify the combination of variables at different time points that indicate venous congestion and predict patient outcome. Secondary objectives are to identify a combination of CCUS variables that precede serum creatine rises in patients who develop acute kidney injury (AKI) after an acute ICU admission {diagnostic}; to identify a combination of variables per organ system or subset of populations to predict short-term organ deterioration and 7-day mortality {prognostic}; to identify a combination of variables over 48 hours of ICU admission that predict long-term (90 day) morbidity and mortality {prognostic} and; to validate multiple prognostic risk scores developed for critically ill ICU patients.

Conditions

Critical Illness

Keywords

Critical Illness; Acute Disease; Shock; Acute Kidney Injury; Ultrasonography

Outcome Measures

Primary Outcomes (4)

• The combination of variables at different time points that indicate venous congestion and predict patient outcome in the critically ill.

  Venous congestion is not yet well defined. We measure multiple variables which, if combined, may indicate venous congestion. These variables will be analysed and used to compute a cut-offs for venous congestion. The primary outcome is the incidence of venous congestion, the course/trajectory of these variables throughout multiple measurements and its association with patient outcome. The variables that will be measured are obtained using critical care ultrasonography and include amongst others inferior caval vein collapsibility, kerly B-lines as sign of pulmonary edema and right ventricular function. All other variables are listed in the protocol and detailed description.

  7 days

• Short term organ failure

  All short term organ failure within the first seven days such as Acute Kidney Injury (defined by the KDIGO criteria) will be recorded.

  7 days

• Short-term mortality

  Short term mortality and in hospital mortality will be recorded, including mortality reason, extracted from the electronic patient file

  7 days

• Long term mortality

  Long term mortality will be acquired using the municipal personal records database 90 days after inclusion.

  90 days

Secondary Outcomes (4)

• Ultrasonography variables that predict AKI

  7 days

• Predictors for short term organ failure

  7 days

• Predictors for long term mortality

  90 days

• Risk scores

  90 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All acutely admitted critically ill patients that are eligible following our predefined in- and exclusion criteria.

You may qualify if:

• Emergency admission
• Expected stay \> 24 hours

You may not qualify if:

• Age \< 18 years
• Planned admission either after surgery or for other reasons
• Unable to obtain informed consent, e.g. refusal, suicide attempts due to acute psychiatric 'derailment', mental retardation or a language barrier
• Strict isolation due to contagious disease
• Non-traumatic neurological reason for admission (i.e. after thrombolysis or spontaneous subarachnoid haemorrhage)

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

Location

Related Publications (5)

• Hiemstra B, Koster G, Wiersema R, Hummel YM, van der Harst P, Snieder H, Eck RJ, Kaufmann T, Scheeren TWL, Perner A, Wetterslev J, de Smet AMGA, Keus F, van der Horst ICC; SICS Study Group. The diagnostic accuracy of clinical examination for estimating cardiac index in critically ill patients: the Simple Intensive Care Studies-I. Intensive Care Med. 2019 Feb;45(2):190-200. doi: 10.1007/s00134-019-05527-y. Epub 2019 Jan 31.

  PMID: 30706120 BACKGROUND

• Wiersema R, Castela Forte JN, Kaufmann T, de Haas RJ, Koster G, Hummel YM, Koeze J, Franssen CFM, Vos ME, Hiemstra B, Keus F, van der Horst ICC. Observational Study Protocol for Repeated Clinical Examination and Critical Care Ultrasonography Within the Simple Intensive Care Studies. J Vis Exp. 2019 Jan 16;(143). doi: 10.3791/58802.

  PMID: 30735183 BACKGROUND

• Hiemstra B, Eck RJ, Koster G, Wetterslev J, Perner A, Pettila V, Snieder H, Hummel YM, Wiersema R, de Smet AMGA, Keus F, van der Horst ICC; SICS Study Group. Clinical examination, critical care ultrasonography and outcomes in the critically ill: cohort profile of the Simple Intensive Care Studies-I. BMJ Open. 2017 Sep 27;7(9):e017170. doi: 10.1136/bmjopen-2017-017170.

  PMID: 28963297 BACKGROUND

• Wiersema R, Kaufmann T, van der Veen HN, de Haas RJ, Franssen CFM, Koeze J, van der Horst ICC, Keus F; SICS Study Group. Diagnostic accuracy of arterial and venous renal Doppler assessment for acute kidney injury in critically ill patients: A prospective study. J Crit Care. 2020 Oct;59:57-62. doi: 10.1016/j.jcrc.2020.05.012. Epub 2020 May 27.

  PMID: 32526633 BACKGROUND

• Wiersema R, Jukarainen S, Eck RJ, Kaufmann T, Koeze J, Keus F, Pettila V, van der Horst ICC, Vaara ST. Different applications of the KDIGO criteria for AKI lead to different incidences in critically ill patients: a post hoc analysis from the prospective observational SICS-II study. Crit Care. 2020 Apr 21;24(1):164. doi: 10.1186/s13054-020-02886-7.

  PMID: 32316994 BACKGROUND

Related Links

• Our research line website.

MeSH Terms

Conditions

Critical Illness; Acute Disease; Shock; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Frederik Keus

Study Record Dates

• First Submitted: June 23, 2018
• First Posted: July 5, 2018
• Study Start: May 14, 2018
• Primary Completion: July 10, 2019
• Study Completion: December 10, 2019
• Last Updated: August 27, 2020

Record last verified: 2020-08

Locations

NL (1)