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
Verified date | April 2019 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
LODS score for deceased ICU patients within 30 days is higher than survived ICU patients
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 |
Country | Name | City | State |
---|---|---|---|
Indonesia | Rumah Sakit Cipto Mangunkusumo | Jakarta Pusat | DKI Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University |
Indonesia,
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* Note: There are 44 references in all — Click here to view all references
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 |
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