LODS Role in Predicting 30-day Mortality Outcome in ICU

NCT03930160 | Completed

• 1 other identifier: IndonesiaUAnes035
• Study Type: observational
• Target: 439
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mortality

Keywords

Intensive care unit; Logistic Organ Dysfunction System; 30-day Mortality; Sepsis; Mortality prediction

Outcome Measures

Primary Outcomes (3)

• LODS score discrimination ability

  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

  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

  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 Outcomes (7)

• Patient outcome

  30 days from admission

• LODS neurologic variable score: Glasgow Coma Scale (GCS)

  Day 1

• LODS cardiovascular variable score: Heart rate (HR) and/or systolic blood pressure (SBP)

  Day 1

• LODS renal variable score: serum urea nitrogen (BUN) and/or creatinine and/or urine output (UO)

  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)

  Day 1

Study Arms (1)

Mortality outcome

Other: Logistic Organ Dysfunction System Score

Interventions

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.

Also known as: LODS

Mortality outcome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

intensive care unit patients medical records

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Rumah Sakit Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

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MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Anesthesiologist Consultant

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 29, 2019
• Study Start: May 17, 2018
• Primary Completion: August 17, 2018
• Study Completion: November 23, 2018
• Last Updated: April 29, 2019

Record last verified: 2019-04

Locations

ID (1)