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出境医 / 临床实验 / LODS Role in Predicting 30-day Mortality Outcome in ICU

LODS Role in Predicting 30-day Mortality Outcome in ICU

Study Description
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

Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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.



Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Locations
Layout table for location information
Indonesia
Rumah Sakit Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Tracking Information
First Submitted Date April 24, 2019
First Posted Date April 29, 2019
Last Update Posted Date April 29, 2019
Actual Study Start Date May 17, 2018
Actual Primary Completion Date August 17, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 24, 2019)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 24, 2019)
  • Patient outcome [ Time Frame: 30 days from admission ]
    Patient outcome within 30 days of admission to intensive care unit (ICU): deceased or survived
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title LODS Role in Predicting 30-day Mortality Outcome in ICU
Official Title Logistic Organ Dysfunction System Role in Predicting 30-day Mortality Outcome in Intensive Care Unit of dr. Cipto Mangunkusumo General Hospital Patients
Brief Summary LODS score for deceased ICU patients within 30 days is higher than survived ICU patients
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population intensive care unit patients medical records
Condition Mortality
Intervention 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
Study Groups/Cohorts Mortality outcome
Intervention: Other: Logistic Organ Dysfunction System Score
Publications *
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  • Heldwein MB, Badreldin AM, Doerr F, Lehmann T, Bayer O, Doenst T, Hekmat K. Logistic Organ Dysfunction Score (LODS): a reliable postoperative risk management score also in cardiac surgical patients? J Cardiothorac Surg. 2011 Sep 16;6:110. doi: 10.1186/1749-8090-6-110.
  • Kim TK, Yoon JR. Comparison of the predictive power of the LODS and APACHE II scoring systems in a neurological intensive care unit. J Int Med Res. 2012;40(2):777-86.
  • Saranya AVR S. Comparison of Different Scoring Systems Used in the Intensive Care Unit. Journal of Pulmonary & Respiratory Medicine. 2015;05(04).
  • Timsit JF, Fosse JP, Troché G, De Lassence A, Alberti C, Garrouste-Orgeas M, Azoulay E, Chevret S, Moine P, Cohen Y. Accuracy of a composite score using daily SAPS II and LOD scores for predicting hospital mortality in ICU patients hospitalized for more than 72 h. Intensive Care Med. 2001 Jun;27(6):1012-21.
  • Timsit JF, Fosse JP, Troché G, De Lassence A, Alberti C, Garrouste-Orgeas M, Bornstain C, Adrie C, Cheval C, Chevret S; OUTCOMEREA Study Group, France. Calibration and discrimination by daily Logistic Organ Dysfunction scoring comparatively with daily Sequential Organ Failure Assessment scoring for predicting hospital mortality in critically ill patients. Crit Care Med. 2002 Sep;30(9):2003-13.
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  • Hashemian SM, Jamaati H, Farzanegan Bidgoli B, Farrokhi FR, Malekmohammad M, Roozdar S, Mohajerani SA, Bagheri A, Radmnand G, Hatami B, Chitsazan M. Outcome of Acute Kidney Injury in Critical Care Unit, Based on AKI Network. Tanaffos. 2016;15(2):89-95.
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  • Zhang D, Shen X, Qi X. Resting heart rate and all-cause and cardiovascular mortality in the general population: a meta-analysis. CMAJ. 2016 Feb 16;188(3):E53-E63. doi: 10.1503/cmaj.150535. Epub 2015 Nov 23.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 24, 2019) 		439
Original Actual Enrollment Same as current
Actual Study Completion Date November 23, 2018
Actual Primary Completion Date August 17, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number NCT03930160
Other Study ID Numbers IndonesiaUAnes035
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Dita Aditianingsih, Indonesia University
Study Sponsor Indonesia University
Collaborators Not Provided
Investigators Not Provided
PRS Account Indonesia University
Verification Date April 2019

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