LODS Role in Predicting 30-day Mortality Outcome in ICU

Mortality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03930160
• Other study ID #: IndonesiaUAnes035
• Status: Completed
• Start date: May 17, 2018
• Est. completion date: November 23, 2018

Study information

• Verified date: April 2019
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: November 23, 2018
• Est. primary completion date: August 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
Indonesia	Rumah Sakit Cipto Mangunkusumo	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (44)

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* Note: There are 44 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Patient outcome	Patient outcome within 30 days of admission to intensive care unit (ICU): deceased or survived	30 days from admission
Secondary	LODS neurologic variable score: Glasgow Coma Scale (GCS)	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
Secondary	LODS cardiovascular variable score: Heart rate (HR) and/or systolic blood pressure (SBP)	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
Secondary	LODS renal variable score: serum urea nitrogen (BUN) and/or creatinine and/or urine output (UO)	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
Secondary	LODS pulmonary variable score: Partial oxygen pressure (PaO2)/Fraction of inspired oxygen (FiO2) on Mechanical Ventilation (MV) or Continuous Positive Airway Pressure (CPAP)	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
Secondary	LODS hematologic variable score: white blood cell (WBC) count and/or platelet count	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
Secondary	LODS hepatic function variable score: Serum Bilirubin and/or Prothrombin time (PT)	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