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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

LODS Role in Predicting 30-day Mortality Outcome in ICU

Clinicaltrials.gov identifier NCT03930160

Recruitment Status Completed

First Posted April 29, 2019

Last update posted April 29, 2019

Study Description

Brief summary:

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

  • Condition or Disease:Mortality
  • Intervention/Treatment: Other: Logistic Organ Dysfunction System Score
  • Phase: N/A
Detailed Description

N/A

Study Design
  • 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 2018
  • Actual Primary Completion Date: August 2018
  • Actual Study Completion Date: November 2018
Groups and Cohorts
Groups/Cohorts 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.
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
  • 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
Contacts
Locations

Indonesia, DKI Jakarta
Rumah Sakit Cipto Mangunkusumo
Jakarta Pusat

Sponsors and Collaborators

Indonesia University

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