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Completed

NCT Number: NCT03930160

LODS Role in Predicting 30-day Mortality Outcome in ICU

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

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Key information

Conditions

Mortality Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rumah Sakit Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Logistic Organ Dysfunction System Score

Other

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 names: LODS

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Logistic Organ Dysfunction System Role in Predicting 30-day Mortality Outcome in Intensive Care Unit of dr. Cipto Mangunkusumo General Hospital Patients

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 29, 2019
Registry last updated
Apr 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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