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MortalityNCT03930160

LODS Role in Predicting 30-day Mortality Outcome in ICU

An observational study of Mortality, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

LODS score for deceased ICU patients within 30 days is higher than survived ICU patients Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mortality
What is being tested?
Logistic Organ Dysfunction System Score
How many people
439 participants
Where
1 siteIndonesia
Study dates
17 May 2018to 23 Nov 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: intensive care unit patients medical records

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Rumah Sakit Cipto Mangunkusumo

    Jakarta Pusat, DKI Jakarta, 10430

Other trials in Indonesia

About this study

Official title: 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

Conditions
Mortality
Being tested
Logistic Organ Dysfunction System Score
Keywords
Intensive care unit, Logistic Organ Dysfunction System, 30-day Mortality, Sepsis, Mortality prediction
Medical subject headings
Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Logistic Organ Dysfunction System ScoreOther

    Also called LODS

    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.

Study groups in NCT03930160
Study groupRoleWhat they receive
Mortality outcomeNot described
Receives: Other: Logistic Organ Dysfunction System Score

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 days from admission

  2. 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.

    Measured: 30 days from admission

  3. 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.

    Measured: 30 days from admission

Secondary outcomes (7)

  1. Patient outcome

    Patient outcome within 30 days of admission to intensive care unit (ICU): deceased or survived

    Measured: 30 days from admission

  2. 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.

    Measured: Day 1

  3. 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.

    Measured: Day 1

  4. 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.

    Measured: Day 1

  5. 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.

    Measured: Day 1

  6. 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

    Measured: Day 1

  7. 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.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2019
  2. Study start17 May 2018
  3. Primary completion17 Aug 2018
  4. Study completion23 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
439 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03930160
Sponsor's protocol ID
IndonesiaUAnes035
Status last verified
Apr 2019
First submitted
24 Apr 2019
Last updated
29 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Power GS, Harrison DA. Why try to predict ICU outcomes? Curr Opin Crit Care. 2014 Oct;20(5):544-9. doi: 10.1097/MCC.0000000000000136.

    PubMed 25159474

  • Rapsang AG, Shyam DC. Scoring systems in the intensive care unit: A compendium. Indian J Crit Care Med. 2014 Apr;18(4):220-8. doi: 10.4103/0972-5229.130573.

    PubMed 24872651

  • Purnama Dewi O, Nurfitri E. Pediatric logistic organ dysfunction score as a predictive tool of dengue shock syndrome outcomes. Paediatrica Indonesiana. 2012;52(2):72-77.

  • Grenvik A, Ayres SM, Holbrook PR, Shoemaker WC, editors. Textbook of Critical Care. Subsequent edition. Philadelphia: W B Saunders Co; 2000. 2227 p

  • Rao SM, Suhasini T. Organization of intensive care unit and predicting outcome of critical illness. Indian J Anaesth. 2003;47(5):328-37.

  • Le Gall JR, Klar J, Lemeshow S, Saulnier F, Alberti C, Artigas A, Teres D. The Logistic Organ Dysfunction system. A new way to assess organ dysfunction in the intensive care unit. ICU Scoring Group. JAMA. 1996 Sep 11;276(10):802-10. doi: 10.1001/jama.276.10.802.

    PubMed 8769590

  • 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.

    PubMed 21923900

  • Kim TK, Yoon JR. Comparison of the predictive power of the LODS and APACHE II scoring systems in a neurological intensive care unit. J Int Med Res. 2012;40(2):777-86. doi: 10.1177/147323001204000244.

    PubMed 22613443

  • Saranya AVR S. Comparison of Different Scoring Systems Used in the Intensive Care Unit. Journal of Pulmonary & Respiratory Medicine. 2015;05(04).

  • Timsit JF, Fosse JP, Troche G, De Lassence A, Alberti C, Garrouste-Orgeas M, Azoulay E, Chevret S, Moine P, Cohen Y. Accuracy of a composite score using daily SAPS II and LOD scores for predicting hospital mortality in ICU patients hospitalized for more than 72 h. Intensive Care Med. 2001 Jun;27(6):1012-21. doi: 10.1007/s001340100961.

    PubMed 11497133

  • Timsit JF, Fosse JP, Troche 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. doi: 10.1097/00003246-200209000-00009.

    PubMed 12352033

  • Bouch DC, Thompson JP. Severity scoring systems in the critically ill. Contin Educ Anaesth Crit Care Pain. 2008;8:181-5.

  • Dolejs J, Maresova P. Onset of mortality increase with age and age trajectories of mortality from all diseases in the four Nordic countries. Clin Interv Aging. 2017 Jan 21;12:161-173. doi: 10.2147/CIA.S119327. eCollection 2017.

    PubMed 28176929

  • Ingraham AM, Cohen ME, Raval MV, Ko CY, Nathens AB. Comparison of hospital performance in emergency versus elective general surgery operations at 198 hospitals. J Am Coll Surg. 2011 Jan;212(1):20-28.e1. doi: 10.1016/j.jamcollsurg.2010.09.026.

    PubMed 21184955

  • Ball IM, Bagshaw SM, Burns KE, Cook DJ, Day AG, Dodek PM, Kutsogiannis DJ, Mehta S, Muscedere JG, Turgeon AF, Stelfox HT, Wells GA, Stiell IG. Outcomes of elderly critically ill medical and surgical patients: a multicentre cohort study. Can J Anaesth. 2017 Mar;64(3):260-269. doi: 10.1007/s12630-016-0798-4. Epub 2016 Dec 27.

    PubMed 28028673

Questions about this trial

What is this clinical trial studying?

An observational study of Mortality, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LODS score discrimination ability (time frame: 30 days from admission). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03930160, which also lists 44 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2019.

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