Critical IllnessPhase 2NCT03781713
Prospective Clinical Surveillance With Application of Trigger Tools in Critically Ill Patients
A Phase 2 study testing KDIGO, Delta SOFA and Hypoglycemia in people with Critical Illness, run by Hospital Sao Domingos at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- KDIGO, Delta SOFA and Hypoglycemia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Nov 2017to 10 Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
-
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital Sao Domingos
São Luís, Maranhão, 65060-642
Hospital São Domingos
São Luís, Maranhão, 65060-645
About this study
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.
Read the detailed description
In the 1999 landmark report, "To Err is Human: Building a Safe Health System," the Institute of Medicine estimated that avoidable errors in health contributed to 44 to 98,000 deaths and more than 1 million injuries annually in the United States (1). Several years after the publication of this study, numerous initiatives have emerged to improve patient safety in the USA and the world (2).
An important advance in the detection of adverse events is the use of triggers, algorithms that use patient data to look for consistent patterns that predict the onset of an adverse event (3).
The Institute for Health Care Improvement (IHI) has developed several tools with the use of triggers. The Global Trigger Tool (GTT), developed in 2009, is a tool applied retrospectively and proved to be effective in the detection of adverse events (4). It is an easily applicable method for quantifying damage. Countries outside USA did not have the same result with their application and questioned their benefit (5,6,7).
Using a prospective clinical surveillance tool, which consisted of direct observation by a trained nurse, Forster et al (8) identified a high risk of adverse events and a significant variation of risks and sub types between services. These results have suggested that institutions will have to assess service-specific safety issues to define priorities and improvement strategies in the design of care. This model was later used by Wong et al.(9), who identified a wide range of factors contributing to adverse events. Despite the prospective methodology, the impact of the actions instituted to prevent the events was not identified in these studies.
Prospective clinical surveillance with the use of triggers as a tool to identify the risk of adverse events, with the prompt adoption of interventions and evaluation of the evidence of the expected outcome may be the answer to improving patient safety, which remains a major problem of public health 20 years after the publication of the reference "To err is human".
OBJECTIVE To evaluate the impact of prospective trigger tools and near real time interventions on the stabilization time of critically ill patients.
METHOD This is a retrospective cohort study conducted at a surgical intensive care unit (13 beds), a medical intensive care unit (19 beds) and a surgical and trauma high complexity unit (12 beds) of a tertiary hospital. The hospital São Domingos Ethics in Research Committee approved the study (number 1.487.682).
All adult patients (18 years of age or older) who were admitted to one of the four intensive care units were included in the study, in the period from November 1, 2017 to October 30, 2018.
Patients who are readmitted and those with length of ICU stay less than 48 hours were excluded, since this is the minimum time required for the triggering of the trigger and its corresponding intervention.
Once admitted to the ICU and meeting the inclusion criteria, patients were followed by the multidisciplinary surveillance team composed of physicians, nurses, physiotherapists and pharmacists. They conducted a daily active search for the triggers in the medical records. To ensure the reliability of the data collected, each professional is responsible for a specific trigger. If one of them is activated, the team member approaches the care team responsible for the patient within 24 hours, and the data is also presented in the daily multidisciplinary round. This moment is still used to solve all doubts regarding the triggering of the trigger and its respective conduct or change in the therapeutic plan in order to reach the expected result of each trigger.
The prospective trigger tool uses indicators that are capable of predicting serious complications that increase the morbidity and mortality of ICU patients that could be preventable. The triggers used were:
- Acute kidney injury (KDIGO) (10) - When triggered, the patient is classified as at risk (1.5 to 1.9 x baseline creatinine or increase of 0.3 mg / dl), injury (2.0 to 2.9 x baseline creatinine) or insufficiency (3 x basal creatinine). It is expected that the risk can be identified early and that therapeutic interventions be undertaken in order to prevent progression to renal replacement therapy.
- Delta SOFA (11)- The SOFA (Sequential Organ Failure Assessment) of all patients are calculated on the first and third days. The increase in this score on the third day identify clinical worsening, triggering the trigger and requiring revision of the initial therapeutic plan. The impact of this change is analyzed by calculating the fifth day SOFA, which should be lower.
- Hypoglycaemia (glycemia <60 mg / dl) - Once this trigger is activated, it is expected that the clinical intervention will be effective to prevent the recurrence of hypoglycemia in the next 24 hours.
- Drug interaction risk D or X - When identifying a D or X risk interaction in the patient's prescription, the assistant team is advised to make alterations in the therapeutic plan in order to avoid adverse drug reactions.
- Antimicrobial stewardship - Whenever an antimicrobial regimen is started or modified it is assessed for its suitability through MALDI-TOF and sensitivity test. If there is no microbiological identification, the clinical improvement, represented by at least two of the three following parameters (leukocyte drop, absence of fever and improvement of CRP) is taken into account.
Demographic data also were collected including age, gender, hospitalization category (clinical or surgical), Charlson comorbidities index and score and SAPS 3 (Simplified Acute Physiology Score 3) with its respective risk of death.
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 (Epimed solutions) will be used, which allows us to estimate the length of ICU stay of the patients individually using more than 60 variables.
- Conditions
- Critical Illness
- Being tested
- KDIGO, Delta SOFA, Hypoglycemia, Drug interaction risk D or X, Antimicrobial stewardship
- Keywords
- prospective, surveillance, trigger, stabilization
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KDIGOOther
Interventions to prevent renal replacement therapy
Delta SOFAOther
interventions to improve SOFA score
HypoglycemiaCombination product
Interventions to prevent new episodes of hypoglycemia in the next 24 hours
Drug interaction risk D or XDrug
Intervention in the therapeutic plan in order to avoid adverse drug reactions.
Antimicrobial stewardshipDrug
Optimization of anticrobial therapy based on Gram stain, MALDI TOF, MIC and antimicrobial susceptibility
| Study group | Role | What they receive |
|---|---|---|
| STUDY GROUP | Active comparator | 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 Receives: Other: KDIGO; Other: Delta SOFA; Combination Product: Hypoglycemia; Drug: Drug interaction risk D or X; Drug: Antimicrobial stewardship |
| CONTROL GROUP | No intervention | patients who did not triggered triggers |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the impact of prospective trigger tools and near real time interventions on the stabilization time of critically ill patients.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start1 Nov 2017
- Primary completion31 Oct 2018
- Study completion10 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sao Domingos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Raimundo Araujo de Azevedo, Hospital Sao Domingos
- Investigators
- JOSE R AZEVEDO, MD. PhD, Study chair, Hospital Sao Domingos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781713
- Sponsor's protocol ID
- CONEP 1.487.682
- Status last verified
- Dec 2018
- First submitted
- 18 Dec 2018
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Landrigan CP, Parry GJ, Bones CB, Hackbarth AD, Goldmann DA, Sharek PJ. Temporal trends in rates of patient harm resulting from medical care. N Engl J Med. 2010 Nov 25;363(22):2124-34. doi: 10.1056/NEJMsa1004404.
PubMed 21105794Institute of Medicine (US) Committee on Quality of Health Care in America; Kohn LT, Corrigan JM, Donaldson MS, editors. To Err is Human: Building a Safer Health System. Washington (DC): National Academies Press (US); 2000. Available from http://www.ncbi.nlm.nih.gov/books/NBK225182/
PubMed 25077248Griffin FA, Classen DC. Detection of adverse events in surgical patients using the Trigger Tool approach. Qual Saf Health Care. 2008 Aug;17(4):253-8. doi: 10.1136/qshc.2007.025080.
PubMed 186787214. 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.
Franklin BD, Birch S, Schachter M, Barber N. Testing a trigger tool as a method of detecting harm from medication errors in a UK hospital: a pilot study. Int J Pharm Pract. 2010 Oct;18(5):305-11. doi: 10.1111/j.2042-7174.2010.00058.x.
PubMed 20840687Carnevali L, Krug B, Amant F, Van Pee D, Gerard V, de Bethune X, Spinewine A. Performance of the adverse drug event trigger tool and the global trigger tool for identifying adverse drug events: experience in a Belgian hospital. Ann Pharmacother. 2013 Nov;47(11):1414-9. doi: 10.1177/1060028013500939.
PubMed 24285758Forster AJ, Worthington JR, Hawken S, Bourke M, Rubens F, Shojania K, van Walraven C. Using prospective clinical surveillance to identify adverse events in hospital. BMJ Qual Saf. 2011 Sep;20(9):756-63. doi: 10.1136/bmjqs.2010.048694. Epub 2011 Mar 1.
PubMed 21367769Wong BM, Dyal S, Etchells EE, Knowles S, Gerard L, Diamantouros A, Mehta R, Liu B, Baker GR, Shojania KG. Application of a trigger tool in near real time to inform quality improvement activities: a prospective study in a general medicine ward. BMJ Qual Saf. 2015 Apr;24(4):272-81. doi: 10.1136/bmjqs-2014-003432. Epub 2015 Mar 6.
PubMed 2574902810. Kdigo Clinical Practice Guideline for acute kidney injury. Kidney International 2012; 2 9Suppl 1).
Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.
PubMed 8844239
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Surveillance With Application of Trigger Tools in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03781713
- Acronym / sponsor ID
- CONEP 1.487.682
- Conditions
- Critical Illness
- Keywords
- prospective, surveillance, trigger, stabilization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Hospital Sao DomingosUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the 1999 landmark report, "To Err is Human: Building a Safe Health System," the Institute of Medicine estimated that avoidable errors in health contributed to 44 to 98,000 deaths and more than 1 million injuries annually in the United States (1). Several years after the publication of this study, numerous initiatives have emerged to improve patient safety in the USA and the world (2).
An important advance in the detection of adverse events is the use of triggers, algorithms that use patient data to look for consistent patterns that predict the onset of an adverse event (3).
The Institute for Health Care Improvement (IHI) has developed several tools with the use of triggers. The Global Trigger Tool (GTT), developed in 2009, is a tool applied retrospectively and proved to be effective in the detection of adverse events (4). It is an easily applicable method for quantifying damage. Countries outside USA did not have the same result with their application and questioned their benefit (5,6,7).
Using a prospective clinical surveillance tool, which consisted of direct observation by a trained nurse, Forster et al (8) identified a high risk of adverse events and a significant variation of risks and sub types between services. These results have suggested that institutions will have to assess service-specific safety issues to define priorities and improvement strategies in the design of care. This model was later used by Wong et al.(9), who identified a wide range of factors contributing to adverse events. Despite the prospective methodology, the impact of the actions instituted to prevent the events was not identified in these studies.
Prospective clinical surveillance with the use of triggers as a tool to identify the risk of adverse events, with the prompt adoption of interventions and evaluation of the evidence of the expected outcome may be the answer to improving patient safety, which remains a major problem of public health 20 years after the publication of the reference "To err is human".
OBJECTIVE To evaluate the impact of prospective trigger tools and near real time interventions on the stabilization time of critically ill patients.
METHOD This is a retrospective cohort study conducted at a surgical intensive care unit (13 beds), a medical intensive care unit (19 beds) and a surgical and trauma high complexity unit (12 beds) of a tertiary hospital. The hospital São Domingos Ethics in Research Committee approved the study (number 1.487.682).
All adult patients (18 years of age or older) who were admitted to one of the four intensive care units were included in the study, in the period from November 1, 2017 to October 30, 2018.
Patients who are readmitted and those with length of ICU stay less than 48 hours were excluded, since this is the minimum time required for the triggering of the trigger and its corresponding intervention.
Once admitted to the ICU and meeting the inclusion criteria, patients were followed by the multidisciplinary surveillance team composed of physicians, nurses, physiotherapists and pharmacists. They conducted a daily active search for the triggers in the medical records. To ensure the reliability of the data collected, each professional is responsible for a specific trigger. If one of them is activated, the team member approaches the care team responsible for the patient within 24 hours, and the data is also presented in the daily multidisciplinary round. This moment is still used to solve all doubts regarding the triggering of the trigger and its respective conduct or change in the therapeutic plan in order to reach the expected result of each trigger.
The prospective trigger tool uses indicators that are capable of predicting serious complications that increase the morbidity and mortality of ICU patients that could be preventable. The triggers used were:
- Acute kidney injury (KDIGO) (10) - When triggered, the patient is classified as at risk (1.5 to 1.9 x baseline creatinine or increase of 0.3 mg / dl), injury (2.0 to 2.9 x baseline creatinine) or insufficiency (3 x basal creatinine). It is expected that the risk can be identified early and that therapeutic interventions be undertaken in order to prevent progression to renal replacement therapy.
- Delta SOFA (11)- The SOFA (Sequential Organ Failure Assessment) of all patients are calculated on the first and third days. The increase in this score on the third day identify clinical worsening, triggering the trigger and requiring revision of the initial therapeutic plan. The impact of this change is analyzed by calculating the fifth day SOFA, which should be lower.
- Hypoglycaemia (glycemia <60 mg / dl) - Once this trigger is activated, it is expected that the clinical intervention will be effective to prevent the recurrence of hypoglycemia in the next 24 hours.
- Drug interaction risk D or X - When identifying a D or X risk interaction in the patient's prescription, the assistant team is advised to make alterations in the therapeutic plan in order to avoid adverse drug reactions.
- Antimicrobial stewardship - Whenever an antimicrobial regimen is started or modified it is assessed for its suitability through MALDI-TOF and sensitivity test. If there is no microbiological identification, the clinical improvement, represented by at least two of the three following parameters (leukocyte drop, absence of fever and improvement of CRP) is taken into account.
Demographic data also were collected including age, gender, hospitalization category (clinical or surgical), Charlson comorbidities index and score and SAPS 3 (Simplified Acute Physiology Score 3) with its respective risk of death.
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 (Epimed solutions) will be used, which allows us to estimate the length of ICU stay of the patients individually using more than 60 variables.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| STUDY GROUP | Active comparator | Other: KDIGO, Other: Delta SOFA, Combination Product: Hypoglycemia, Drug: Drug interaction risk D or X, Drug: Antimicrobial stewardshippatients 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 |
| CONTROL GROUP | No intervention | –patients who did not triggered triggers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KDIGOInterventions to prevent renal replacement therapy | Other | STUDY GROUP |
| Delta SOFAinterventions to improve SOFA score | Other | STUDY GROUP |
| HypoglycemiaInterventions to prevent new episodes of hypoglycemia in the next 24 hours | Combination product | STUDY GROUP |
| Drug interaction risk D or XIntervention in the therapeutic plan in order to avoid adverse drug reactions. | Drug | STUDY GROUP |
| Antimicrobial stewardshipOptimization of anticrobial therapy based on Gram stain, MALDI TOF, MIC and antimicrobial susceptibility | Drug | STUDY GROUP |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
- Background: PubMed 21105794Landrigan CP, Parry GJ, Bones CB, Hackbarth AD, Goldmann DA, Sharek PJ. Temporal trends in rates of patient harm resulting from medical care. N Engl J Med. 2010 Nov 25;363(22):2124-34. doi: 10.1056/NEJMsa1004404.
- Results publication: PubMed 25077248Institute of Medicine (US) Committee on Quality of Health Care in America; Kohn LT, Corrigan JM, Donaldson MS, editors. To Err is Human: Building a Safer Health System. Washington (DC): National Academies Press (US); 2000. Available from http://www.ncbi.nlm.nih.gov/books/NBK225182/
- Results publication: PubMed 18678721Griffin FA, Classen DC. Detection of adverse events in surgical patients using the Trigger Tool approach. Qual Saf Health Care. 2008 Aug;17(4):253-8. doi: 10.1136/qshc.2007.025080.
- Results publication4. Griffin FA, Resar RK. IHI global trigger tool for measuring adverse events. 2nd edn. Cambridge, Massachusetts Institute for Healthcare Improvement, 2009.
- Results publication5. Shimada S, Rivard PE, Mull J, et al. Triggers and Targeted Injury Detection Systems: Aiming for the Right Target With the Appropriate Tool. 2009.
- Results publication: PubMed 20840687Franklin BD, Birch S, Schachter M, Barber N. Testing a trigger tool as a method of detecting harm from medication errors in a UK hospital: a pilot study. Int J Pharm Pract. 2010 Oct;18(5):305-11. doi: 10.1111/j.2042-7174.2010.00058.x.
- Results publication: PubMed 24285758Carnevali L, Krug B, Amant F, Van Pee D, Gerard V, de Bethune X, Spinewine A. Performance of the adverse drug event trigger tool and the global trigger tool for identifying adverse drug events: experience in a Belgian hospital. Ann Pharmacother. 2013 Nov;47(11):1414-9. doi: 10.1177/1060028013500939.
- Results publication: PubMed 21367769Forster AJ, Worthington JR, Hawken S, Bourke M, Rubens F, Shojania K, van Walraven C. Using prospective clinical surveillance to identify adverse events in hospital. BMJ Qual Saf. 2011 Sep;20(9):756-63. doi: 10.1136/bmjqs.2010.048694. Epub 2011 Mar 1.
- Results publication: PubMed 25749028Wong BM, Dyal S, Etchells EE, Knowles S, Gerard L, Diamantouros A, Mehta R, Liu B, Baker GR, Shojania KG. Application of a trigger tool in near real time to inform quality improvement activities: a prospective study in a general medicine ward. BMJ Qual Saf. 2015 Apr;24(4):272-81. doi: 10.1136/bmjqs-2014-003432. Epub 2015 Mar 6.
- Results publication10. Kdigo Clinical Practice Guideline for acute kidney injury. Kidney International 2012; 2 9Suppl 1).
- Results publication: PubMed 8844239Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JOSE R AZEVEDO, MD. PhD study chair
Hospital Sao Domingos
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KDIGO, Delta SOFA and Hypoglycemia in people with Critical Illness, run by Hospital Sao Domingos at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03781713, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2018; AzTrials last refreshed its copy on 6 Nov 2026.