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The Stress Ulcer Prophylaxis in the Intensive Care Unit Score
The SUP-ICU Score
A clinical prediction rule of gastrointestinal bleeding
in the ICU
Søren Marker, MD
Dept. of Intensive Care 4131, Rigshospitalet, Copenhagen
08.09.17
Thank you to the Acta Anaesthesiologica
Scandinavica Foundation for this research
grant!
The SUP-ICU Score – A clinical prediction rule of GI bleeding in the ICU
The SUP-ICU trial
• Design: Ongoing internationational placebo-
controlled RCT
• Population: 3350 ICU patients
• Intervention: IV PPI (pantoprazole)
• Comparator: IV placebo (saline)
• Primary outcome: 90-day mortality
• Setting:
Søren MarkerThe SUP-ICU Score – A clinical prediction rule of GI bleeding in the ICU
The SUP-ICU Score
Background
• Use of clinical prediction rules to identify patients
with high risk of GI bleeding is not standard
• Surviving Sepsis Campaign Guidelines 2016
recommends SUP for high risk patients
Søren MarkerThe SUP-ICU Score – A clinical prediction rule of GI bleeding in the ICU
Objective
• To develop and validate a clinical prediction rule –
the SUP-ICU score – which can be used upon ICU
admission to identify ICU patients with high risk of
developing GI bleeding during ICU stay
Søren MarkerThe SUP-ICU Score – A clinical prediction rule of GI bleeding in the ICU
Working hypothesis
• The SUP-ICU score can be used to estimate the
risk of developing GI bleeding during ICU stay
Søren MarkerThe SUP-ICU Score – A clinical prediction rule of GI bleeding in the ICU
Study population
• All 1675 patients included in the placebo-group in
the SUP-ICU trial
Søren MarkerThe SUP-ICU Score – A clinical prediction rule of GI bleeding in the ICU
Candidate variables
• Variables readily available at baseline which may
increase the risk of GI bleeding……
Krag et al. ICM 2015
Søren MarkerThe SUP-ICU Score – A clinical prediction rule of GI bleeding in the ICU
Risk factors for clinically important GI
bleedning
OR (95% CI)
3 or more co-existing diseases 8.9 (2.7-28.2)
Dialysis 6.9 (2.7-17.5)
Chronic liver failure 6.7 (3.3-17.6)
Acute coagulopathy 5.2 (2.3-11.8)
Chronic coagulopathy 4.2 (1.7-10.2)
Use of acid suppressants 3.6 (1.3-10.2)
SOFA score 1.4 (1.2-1.5)
(Shock) 2.3 (1.0-5.4)
Outcome measure
• Clinically important* GI bleeding during ICU stay.
(*Definition: overt (hematemesis, coffee ground emesis, melena, hematochezia or bloody
nasogastric aspirate) GI bleeding AND ≥1 of the following features within 24 hours of GI
bleeding: 1) spontaneous drop of systolic, mean arterial pressure or diastolic blood pressure
of 20 mmHg or more, 2) start of vasopressor or a 20% increase in vasopressor dose 3)
decrease in hemoglobin of at least 2 g/dl (1.24 mmol/L), or 4) transfusion of 2 units of
packed red blood cells or more)
Søren MarkerThe SUP-ICU Score – A clinical prediction rule of GI bleeding in the ICU
Development of the SUP-ICU Score
Søren MarkerThe SUP-ICU Score – A clinical prediction rule of GI bleeding in the ICU
Labarère et al. ICM 2014
Timeline
• Fall 2017: Finalising
protocol
• Spring 2018: Development
of the score
• Fall 2018: Submission to
international peer reviewed
journal
Søren MarkerThe SUP-ICU Score – A clinical prediction rule of GI bleeding in the ICU
Søren MarkerThe SUP-ICU Score – A clinical prediction rule of GI bleeding in the ICU
Research group
Søren Marker
Anders Perner
Jørn Wetterslev
Anders Granholm
Mette Krag
Aksel KG Jensen
Morten Hylander Møller
Søren MarkerThe SUP-ICU Score – A clinical prediction rule of GI bleeding in the ICU
Thank you!
Søren Marker, MD, PhD-student
Dept. of Intensive Care 4131
Rigshospitalet, Copenhagen
Email: soeren.marker@gmail.com

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The SUP-ICU score

  • 1. The Stress Ulcer Prophylaxis in the Intensive Care Unit Score The SUP-ICU Score A clinical prediction rule of gastrointestinal bleeding in the ICU Søren Marker, MD Dept. of Intensive Care 4131, Rigshospitalet, Copenhagen 08.09.17
  • 2. Thank you to the Acta Anaesthesiologica Scandinavica Foundation for this research grant! The SUP-ICU Score – A clinical prediction rule of GI bleeding in the ICU
  • 3. The SUP-ICU trial • Design: Ongoing internationational placebo- controlled RCT • Population: 3350 ICU patients • Intervention: IV PPI (pantoprazole) • Comparator: IV placebo (saline) • Primary outcome: 90-day mortality • Setting: Søren MarkerThe SUP-ICU Score – A clinical prediction rule of GI bleeding in the ICU
  • 4. The SUP-ICU Score Background • Use of clinical prediction rules to identify patients with high risk of GI bleeding is not standard • Surviving Sepsis Campaign Guidelines 2016 recommends SUP for high risk patients Søren MarkerThe SUP-ICU Score – A clinical prediction rule of GI bleeding in the ICU
  • 5. Objective • To develop and validate a clinical prediction rule – the SUP-ICU score – which can be used upon ICU admission to identify ICU patients with high risk of developing GI bleeding during ICU stay Søren MarkerThe SUP-ICU Score – A clinical prediction rule of GI bleeding in the ICU
  • 6. Working hypothesis • The SUP-ICU score can be used to estimate the risk of developing GI bleeding during ICU stay Søren MarkerThe SUP-ICU Score – A clinical prediction rule of GI bleeding in the ICU
  • 7. Study population • All 1675 patients included in the placebo-group in the SUP-ICU trial Søren MarkerThe SUP-ICU Score – A clinical prediction rule of GI bleeding in the ICU
  • 8. Candidate variables • Variables readily available at baseline which may increase the risk of GI bleeding…… Krag et al. ICM 2015 Søren MarkerThe SUP-ICU Score – A clinical prediction rule of GI bleeding in the ICU Risk factors for clinically important GI bleedning OR (95% CI) 3 or more co-existing diseases 8.9 (2.7-28.2) Dialysis 6.9 (2.7-17.5) Chronic liver failure 6.7 (3.3-17.6) Acute coagulopathy 5.2 (2.3-11.8) Chronic coagulopathy 4.2 (1.7-10.2) Use of acid suppressants 3.6 (1.3-10.2) SOFA score 1.4 (1.2-1.5) (Shock) 2.3 (1.0-5.4)
  • 9. Outcome measure • Clinically important* GI bleeding during ICU stay. (*Definition: overt (hematemesis, coffee ground emesis, melena, hematochezia or bloody nasogastric aspirate) GI bleeding AND ≥1 of the following features within 24 hours of GI bleeding: 1) spontaneous drop of systolic, mean arterial pressure or diastolic blood pressure of 20 mmHg or more, 2) start of vasopressor or a 20% increase in vasopressor dose 3) decrease in hemoglobin of at least 2 g/dl (1.24 mmol/L), or 4) transfusion of 2 units of packed red blood cells or more) Søren MarkerThe SUP-ICU Score – A clinical prediction rule of GI bleeding in the ICU
  • 10. Development of the SUP-ICU Score Søren MarkerThe SUP-ICU Score – A clinical prediction rule of GI bleeding in the ICU Labarère et al. ICM 2014
  • 11. Timeline • Fall 2017: Finalising protocol • Spring 2018: Development of the score • Fall 2018: Submission to international peer reviewed journal Søren MarkerThe SUP-ICU Score – A clinical prediction rule of GI bleeding in the ICU
  • 12. Søren MarkerThe SUP-ICU Score – A clinical prediction rule of GI bleeding in the ICU Research group Søren Marker Anders Perner Jørn Wetterslev Anders Granholm Mette Krag Aksel KG Jensen Morten Hylander Møller
  • 13. Søren MarkerThe SUP-ICU Score – A clinical prediction rule of GI bleeding in the ICU Thank you! Søren Marker, MD, PhD-student Dept. of Intensive Care 4131 Rigshospitalet, Copenhagen Email: soeren.marker@gmail.com

Editor's Notes

  1. …We would like to thank the foundation for this research grant!
  2. Identification of patients with increased risk of GI bleeding is important for clinical decision-making, as accurate and early identification of high-risk patients may assist in risk stratification and triage regarding the need for prophylactic administration of acid suppressants, stress ulcer prophylaxis (SUP).
  3. Simple and fast to use – clinically relevant E-based layout
  4. Whether it is preferable to derive a clinical prediction model using data from a trial’s control group only (rather than combining data from the intervention and control groups) continues to be debated [7]. Including the randomized treatment variable in multivariable analyses to derive the model may help overcome this problem
  5. We wil use variables readily available at baseline as candidate variables… Here is what were found to be important risk factors in the cohort study from our research group: 1,034 patients in 97 ICUs in 11 countries were included. Clinically important GI bleeding occurred in 2.6% (95 % confidence interval 1.6–3.6 %) of patients. The association between use of acid suppressants on ICU admission and clinically important GI bleeding may reflect that patients with co-existing diseases (comorbidity or increased disease severity) have an a priori higher chance of being prescribed acid suppressants prior to ICU admission on the basis of perceived increased risk of stress ulcer bleeding during critical illness (confounding by indication).
  6. This is the different phases recommended for generating clinical prediction rules… External validation and potentially impact analysis will only be planned/defined at a later stage when we know how the prediction rule will look.
  7. On the right you se the status in the SUP-ICU trial: Less than 10% remaining…
  8. On behalf of the resarch group…
  9. On behalf of the resarch group…