LODS Role in Predicting 30-day Mortality Outcome in ICU

April 24, 2019 updated by: Dita Aditianingsih, Indonesia University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

439

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Rumah Sakit Cipto Mangunkusumo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

intensive care unit patients medical records

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts 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 Names:
  • LODS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days from admission
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.
30 days from admission
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.
30 days from admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient outcome
Time Frame: 30 days from admission
Patient outcome within 30 days of admission to intensive care unit (ICU): deceased or survived
30 days from admission
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.
Day 1
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.
Day 1
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.
Day 1
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.
Day 1
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
Day 1
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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2018

Primary Completion (Actual)

August 17, 2018

Study Completion (Actual)

November 23, 2018

Study Registration Dates

First Submitted

April 24, 2019

First Submitted That Met QC Criteria

April 24, 2019

First Posted (Actual)

April 29, 2019

Study Record Updates

Last Update Posted (Actual)

April 29, 2019

Last Update Submitted That Met QC Criteria

April 24, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IndonesiaUAnes035

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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