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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03930160
Other study ID # IndonesiaUAnes035
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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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Heldwein MB, Badreldin AM, Doerr F, Lehmann T, Bayer O, Doenst T, Hekmat K. Logistic Organ Dysfunction Score (LODS): a reliable postoperative risk management score also in cardiac surgical patients? J Cardiothorac Surg. 2011 Sep 16;6:110. doi: 10.1186/1749-8090-6-110. — View Citation

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Nik A, Sheikh Andalibi MS, Ehsaei MR, Zarifian A, Ghayoor Karimiani E, Bahadoorkhan G. The Efficacy of Glasgow Coma Scale (GCS) Score and Acute Physiology and Chronic Health Evaluation (APACHE) II for Predicting Hospital Mortality of ICU Patients with Acute Traumatic Brain Injury. Bull Emerg Trauma. 2018 Apr;6(2):141-145. doi: 10.29252/beat-060208. — View Citation

Pierrakos C, Velissaris D, Felleiter P, Antonelli M, Vanhems P, Sakr Y, Vincent JL; EPIC II investigators. Increased mortality in critically ill patients with mild or moderate hyperbilirubinemia. J Crit Care. 2017 Aug;40:31-35. doi: 10.1016/j.jcrc.2017.01.017. Epub 2017 Feb 13. — View Citation

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Su HH, Kao CM, Lin YC, Lin YC, Kao CC, Chen HH, Hsu CC, Chen KC, Peng CC, Wu MS. Relationship between serum total bilirubin levels and mortality in uremia patients undergoing long-term hemodialysis: A nationwide cohort study. Atherosclerosis. 2017 Oct;265:155-161. doi: 10.1016/j.atherosclerosis.2017.09.001. Epub 2017 Sep 4. — View Citation

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Timsit JF, Fosse JP, Troché G, De Lassence A, Alberti C, Garrouste-Orgeas M, Bornstain C, Adrie C, Cheval C, Chevret S; OUTCOMEREA Study Group, France. Calibration and discrimination by daily Logistic Organ Dysfunction scoring comparatively with daily Sequential Organ Failure Assessment scoring for predicting hospital mortality in critically ill patients. Crit Care Med. 2002 Sep;30(9):2003-13. — View Citation

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Zhang Z, Xu X, Ni H, Deng H. Urine output on ICU entry is associated with hospital mortality in unselected critically ill patients. J Nephrol. 2014 Feb;27(1):65-71. doi: 10.1007/s40620-013-0024-1. Epub 2014 Jan 15. — View Citation

* Note: There are 44 references in allClick 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
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