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Prospective Clinical Surveillance With Application of Trigger Tools in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT03781713
Recruitment Status : Completed
First Posted : December 20, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
José Raimundo Araujo de Azevedo, Hospital Sao Domingos

Brief Summary:
This study evaluates the impact of prospective clinical surveillance with the use of triggers to identify risk of adverse events with prompt adoption of interventions on the stabilization time of critically ill patients.

Condition or disease Intervention/treatment Phase
Critical Illness Other: KDIGO Other: Delta SOFA Combination Product: Hypoglycemia Drug: Drug interaction risk D or X Drug: Antimicrobial stewardship Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

To evaluate the impact of the tool on the time of stabilization of patients, two groups will be compared: the first will be composed of patients who did not triggered triggers and the second by patients who triggered triggers and had interventions.

For the calculation of the stabilization time, the long-term risk rating of the Epimed Performance software will be used, which allows us to estimate the length of ICU stay of the patients individually using more than 60 variables.

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective Clinical Surveillance With Application of Trigger Tools in Critically Ill Patients
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : December 10, 2018

Arm Intervention/treatment
Active Comparator: STUDY GROUP
patients who triggered triggers and had interventions. Kdigo: interventions to prevent renal replacement therapy Delta SOFA: interventions to improve SOFA score Hypoglycemia: Interventions to prevent new episodes of hypoglycemia in the next 24 hours Drug interaction risk D or X - Intervention in the therapeutic plan in order to avoid adverse drug reactions. Antimicrobial stewardship: optimization of antimicrobial therapy based on Gram stain, MALDI TOF, MIC, antimicrobial susceptibility
Other: KDIGO
Interventions to prevent renal replacement therapy

Other: Delta SOFA
interventions to improve SOFA score

Combination Product: Hypoglycemia
Interventions to prevent new episodes of hypoglycemia in the next 24 hours

Drug: Drug interaction risk D or X
Intervention in the therapeutic plan in order to avoid adverse drug reactions.

Drug: Antimicrobial stewardship
Optimization of anticrobial therapy based on Gram stain, MALDI TOF, MIC and antimicrobial susceptibility

No Intervention: CONTROL GROUP
patients who did not triggered triggers



Primary Outcome Measures :
  1. To evaluate the impact of prospective trigger tools and near real time interventions on the stabilization time of critically ill patients. [ Time Frame: 3 months ]
    For the calculation of the stabilization time, the long-term risk rating of the Epimed Performance software (Epimed solutions) will be used, which allows us to estimate the length of ICU stay of the patients individually using more than 60 variables.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: All adult patients admitted to the ICU with expexted length of stay of at least 48 hours -

Exclusion Criteria: End of life and exclusive palliative care

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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): NCT03781713


Locations
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Brazil
Hospital São Domingos
Sao Luis, Maranhão, Brazil, 65060-645
Hospital Sao Domingos
Sao Luis, MA, Brazil, 65060-642
Sponsors and Collaborators
Hospital Sao Domingos
Investigators
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Study Chair: JOSE R AZEVEDO, MD. PhD Hospital Sao Domingos

Publications of Results:
1. To err is human: building a Safer Health System. Institute of Medicine (IOM). Washington National Academy Press; 2000.
4. Griffin FA, Resar RK. IHI global trigger tool for measuring adverse events. 2nd edn. Cambridge, Massachusetts Institute for Healthcare Improvement, 2009.
5. Shimada S, Rivard PE, Mull J, et al. Triggers and Targeted Injury Detection Systems: Aiming for the Right Target With the Appropriate Tool. 2009.
10. Kdigo Clinical Practice Guideline for acute kidney injury. Kidney International 2012; 2 9Suppl 1).

Other Publications:
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Responsible Party: José Raimundo Araujo de Azevedo, MD; PhD, Hospital Sao Domingos
ClinicalTrials.gov Identifier: NCT03781713     History of Changes
Other Study ID Numbers: CONEP 1.487.682
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by José Raimundo Araujo de Azevedo, Hospital Sao Domingos:
prospective
surveillance
trigger
stabilization

Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents