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LODS Role in Predicting 30-day Mortality Outcome in ICU

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ClinicalTrials.gov Identifier: NCT03930160
Recruitment Status : Completed
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Dita Aditianingsih, Indonesia University

Brief Summary:
LODS score for deceased ICU patients within 30 days is higher than survived ICU patients

Condition or disease Intervention/treatment
Mortality Other: Logistic Organ Dysfunction System Score

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Study Type : Observational
Actual Enrollment : 439 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Logistic Organ Dysfunction System Role in Predicting 30-day Mortality Outcome in Intensive Care Unit of dr. Cipto Mangunkusumo General Hospital Patients
Actual Study Start Date : May 17, 2018
Actual Primary Completion Date : August 17, 2018
Actual Study Completion Date : November 23, 2018

Group/Cohort Intervention/treatment
Mortality outcome Other: Logistic Organ Dysfunction System Score
Variables of logistic organ dysfunction system score, including: GCS; heart rate; systolic BP; blood urea; serum creatinine; urine output; leucocyte count; platelet count; PaO2/FiO2; serum bilirubin; prothrombin time.
Other Name: LODS




Primary Outcome Measures :
  1. LODS score discrimination ability [ Time Frame: 30 days from admission ]
    LODS score ability to discriminate patient outcomes based on variables of logistic organ dysfunction system scores: GCS; heart rate; systolic BP; blood urea; serum creatinine; urine output; leucocyte count; platelet count; PaO2/FiO2; serum bilirubin; prothrombin time.

  2. LODS score calibration [ Time Frame: 30 days from admission ]
    LODS score ability to predict patient outcomes based on variables of logistic organ dysfunction system scores: GCS; heart rate; systolic BP; blood urea; serum creatinine; urine output; leucocyte count; platelet count; PaO2/FiO2; serum bilirubin; prothrombin time.

  3. Correlation between LODS score variables with patient outcome [ Time Frame: 30 days from admission ]
    Correlation between patient outcomes with each LODS score variables: GCS; heart rate; systolic BP; blood urea; serum creatinine; urine output; leucocyte count; platelet count; PaO2/FiO2; serum bilirubin; prothrombin time.


Secondary Outcome Measures :
  1. Patient outcome [ Time Frame: 30 days from admission ]
    Patient outcome within 30 days of admission to intensive care unit (ICU): deceased or survived

  2. LODS neurologic variable score: Glasgow Coma Scale (GCS) [ Time Frame: Day 1 ]

    The score for GCS variable cutoff:

    0 point for 14-15;

    1 point for 9-13; 3 points for 6-8; 5 points for 3-5.


  3. LODS cardiovascular variable score: Heart rate (HR) and/or systolic blood pressure (SBP) [ Time Frame: Day 1 ]

    The score for HR (in bpm) and/or SBP (in mmHg) variable cutoff:

    0 point for HR 30-139 and SBP 90-239;

    1 point for SBP 70-89 or 240-269 or HR >=140; 3 points for SBP 40-69 or >=270; 5 points for HR <30 or SBP <40.


  4. LODS renal variable score: serum urea nitrogen (BUN) and/or creatinine and/or urine output (UO) [ Time Frame: Day 1 ]

    The score for BUN (in mg/dL) and/or creatinine (in mg/dL) and/or UO (in litres/day) variable cutoff:

    0 point for BUN <17 AND creatinine <1.20 AND UO 0.75-9.99;

    1 point for BUN 17-<28 OR creatinine 1.20-1.59; 3 points for BUN 28-<56 AND creatinine <1.60 AND UO 0.5-0.74 or >=10; 5 points for BUN >=56 OR UO 0.5.


  5. LODS pulmonary variable score: Partial oxygen pressure (PaO2)/Fraction of inspired oxygen (FiO2) on Mechanical Ventilation (MV) or Continuous Positive Airway Pressure (CPAP) [ Time Frame: Day 1 ]

    The score for PaO2/FiO2 (in mmHg/%) variable cutoff:

    0 point for no ventilation and no CPAP;

    1 point for >=150; 3 points for <150.


  6. LODS hematologic variable score: white blood cell (WBC) count and/or platelet count [ Time Frame: Day 1 ]

    The score for WBC (in x10^3/L) and/or platelet count in (x10^3/L) variable cutoff:

    0 point for WBC 2.5-49.9 and platelet >=50;

    1 point for WBC 1.0-2.4 or >=50.0 OR platelet <50; 3 points for WBC <1.0


  7. LODS hepatic function variable score: Serum Bilirubin and/or Prothrombin time (PT) [ Time Frame: Day 1 ]

    The score for serum bilirubin (in mg/dL) and/or PT (in % of standard) variable cutoff:

    0 point for bilirubin <2.0 and PT >=25;

    1 point for bilirubin >=2.0 OR PT<25% or >3.




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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:   Non-Probability Sample
Study Population
intensive care unit patients medical records
Criteria

Inclusion Criteria:

  • adult patient (age 18 years and above) admitted to ICU

Exclusion Criteria:

  • patients admitted to ICU due to burn injury, coronary artery disease, post cardiac surgery
  • patients with incomplete required information for LODS score
  • patients deceased or discharged less than 24 hours of admission

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): NCT03930160


Locations
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Indonesia
Rumah Sakit Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Publications:
Purnama Dewi O, Nurfitri E. Pediatric logistic organ dysfunction score as a predictive tool of dengue shock syndrome outcomes. Paediatrica Indonesiana. 2012;52(2):72-77.
Grenvik A, Ayres SM, Holbrook PR, Shoemaker WC, editors. Textbook of Critical Care. Subsequent edition. Philadelphia: W B Saunders Co; 2000. 2227 p
Rao SM, Suhasini T. Organization of intensive care unit and predicting outcome of critical illness. Indian J Anaesth. 2003;47(5):328-37.
Saranya AVR S. Comparison of Different Scoring Systems Used in the Intensive Care Unit. Journal of Pulmonary & Respiratory Medicine. 2015;05(04).
Bouch DC, Thompson JP. Severity scoring systems in the critically ill. Contin Educ Anaesth Crit Care Pain. 2008;8:181-5.

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Responsible Party: Dita Aditianingsih, MD, PhD, Anesthesiologist Consultant, Indonesia University
ClinicalTrials.gov Identifier: NCT03930160    
Other Study ID Numbers: IndonesiaUAnes035
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019

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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 Dita Aditianingsih, Indonesia University:
Intensive care unit
Logistic Organ Dysfunction System
30-day Mortality
Sepsis
Mortality prediction