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Simple Observational Critical Care Studies (SOCCS)

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ClinicalTrials.gov Identifier: NCT03553069
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
I.C.C. van der Horst, University Medical Center Groningen

Brief Summary:

Each year approximately 3000 patients are admitted to the intensive care unit (ICU) in the University Medical Center Groningen (UMCG). In-hospital mortality of patients with emergency admission approaches 25%. Predicting outcome in the first hours after ICU admission, however, remains a challenge.

An vast amount of scoring systems has been developed for mortality prediction. Well known models, such as the LODS, MODS, CCI, SOFA, ODIN and the different generations of the APACHE, MPM and SAPS, are increasingly compared with new models, such as the SICULA, ICNARC, ANZROD and SMS-ICU. The predictive value of scoring systems deteriorates over time due to changes in patient characteristics and treatment, making it crucial to update existing models or develop new models. Other reasons given for the need of models are the complexity and lack of availability of variables in some of the existing scoring systems, the better discriminating value while using simple, standardly measured variables, and the limited generalizability of some scoring systems in different patient populations. Not only are simple systems (such as the CIS and SMS-ICU) found to be at least as predictive for mortality as complex models such as the APACHE IV, but, while using simplified systems, mortality can also be reasonably predicted within only a few hours after admission. Both simplicity and the potential to predict mortality shortly after admission increase the usability, and consequently the reliability, of those prediction models. This increases the potential of those models to be used in practice.

Most studies however compare only two to four models in their patient population and lack in their description of the performance of the different models. Parameters necessary to compare the performance of models are at least calibration, discrimination, negative predicting value, positive predicting value, sensitivity and specificity. Lacking an adequate description of the performance of the model limits to what extent the study can be used to compare models in different populations. Thus, all usable models should be compared with newly build models, and the performance of the different models should be extensively described to allow comparison of the models.

Not only models based on simple, readily available variables available within hours after admission are promising, but also the concept of combining measurements straight after ICU admission with information on the course of illness. It is likely that the course of a variable over time is more indicative than a static measurement. This study will provide a structure in which every patient admitted to the ICU will be investigated and included within 3 hours and after 12 hours after admission, making longitudinal measurements and various add-on studies possible. Longitudinal measurements are the first example of an add-on study; another example is the capability of nurses and physicians to predict outcome. Current evidence suggests that physicians might predict mortality more accurately than scorings systems. This finding may, however, be highly biased, since at least physicians play a major role in end-of-life decision making. More recent studies also focus on the accuracy of nurses in predicting mortality, with diverse outcomes. The role of other health care professionals, like residents and students, remain to be studied.

Implementing a systematic data collection process is the first step towards making data-driven research possible, a growing need in medical disciplines such as critical care, which requires increasingly more accurate prognostic models. Therefore, the aim of this study is to systematically collect data of all selected variables, thus minimizing incompleteness, and allowing for the calculation of mortality prediction scores according to currently available mortality or severity of disease prediction models. Moreover, during investigation reliability of measurements could be checked for validity. This creates the possibility to compare the performance of all models in one population and identify models which are useful to predict severity of disease. A registry will be created with this primary objective which also provides the opportunity to start multiple ''add-on'' studies for specific research questions. Examples of add-on studies are 1) the association between time-dependent variables which are longitudinally measured, and mortality/acute and chronic co-morbidity, 2) the association between fluid status and acute kidney injury, and 3) not only the capability of the treating physician to predict mortality, but also the capability of the nurses, residents and students to do so.

Purpose:

The purpose of this study is to expand the infrastructure for a registry with longitudinal and repeated measurements, shortly after admittance, which is flexible to incorporate temporarily added specific research questions on the outcome of critically ill patients.


Condition or disease
Critical Illness Acute Disease Shock

Show Show detailed description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Simple Observational Critical Care Studies
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care




Primary Outcome Measures :
  1. To compare the prognostic value of the students' and nurses educated guess with currently available risk scores to predict short term mortality in the ICU. [ Time Frame: 6 months ]
    The nurses and students will be asked to estimate in hospital survival based on gut feeling. Mortality will be recorded. The estimation, the risk assessment using e.g. SAPS and SOFA, and the actual outcome will be measured. We will report the association between these three variables.


Secondary Outcome Measures :
  1. The association between simple observational clinical examination, biochemical, and hemodynamic variables, longitudinally measured, with organ failure prediction and mortality [ Time Frame: 48 hours and 90 days ]

    Acute kidney injury (AKI) was established and classified following the kidney disease: improving global outcomes (KDIGO) criteria. Urine output and serum creatinine measurements from the first 72 hours of inclusion were analyzed to establish and classify AKI severity for each patient.

    Other co-morbidities will be studied according their definition as defined by international guidelines.


  2. To create a research infrastructure allowing collection of variables and efficient screening for eligibility for different studies during evening and night times. [ Time Frame: 2 years ]
    To create a research infrastructure allowing collection of variables and efficient screening for eligibility for different studies during evening and night times.

  3. The long-term mortality outcome [ Time Frame: 3 years ]
    long-term mortality outcome associated with admission to the ICU



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study will be conducted in the department of Critical Care of the University of Groningen, University Medical Center Groningen, a tertiary teaching hospital in the Northern part of the Netherlands.
Criteria

Inclusion Criteria:

  • Emergency admission
  • Expected stay > 24 hours

Exclusion Criteria:

  • Age < 18 years
  • Planned admission either after surgery or for other reasons
  • Suicide attempts due to acute psychiatric 'derailment', mental retardation or a language barrier

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553069


Contacts
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Contact: Iwan C.C. van der Horst, M.D., Ph.D. +31503615617 i.c.c.van.der.horst@umcg.nl

Locations
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Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: Iwan C.C. van der Horst, M.D., Ph.D. University Medical Center Groningen

Additional Information:

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Responsible Party: I.C.C. van der Horst, M.D., Ph.D., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03553069    
Other Study ID Numbers: 201700651
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According guidelines for sharing.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Acute Disease
Disease Attributes
Pathologic Processes