Trial · NCT03764085
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 40
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | A change in the total SOFA score vs. baseline score upon admission; | Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay. | Sequential Organ Failure Assessment (SOFA) score is composed of scores of six organ systems: R-respiratory, C-cardiovascular, H-hepatic, Co-coagulation, Re-renal, and N-neurological graded from 0 to 4 according to the degree of dysfunction or failure. The SOFA score ranges from 0 to 24 points. We evaluate initial SOFA score and differences between subsequent scores (Δ-SOFA scores). |
| Secondary | A change in the total APACHE II score vs. baseline score upon admission; | Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay. | Acute physiology and chronic health evaluation（APACHE) II score is calculated from a patient's age (0-6 points) and 12 physiological parameters (each item 0-4 points): AaDO2 or PaO2 (depending on FiO2), Temperature (rectal), Mean arterial pressure, pH arterial, Heart rate, Respiratory rate, Sodium (serum), Potassium (serum), Creatinine, Hematocrit, White blood cell count, Glasgow Coma Scale and chronic disease health status (0-5 points). The APACHE II score ranges from 0 to 71 points. We evaluate initial APACHE II score and differences between subsequent scores (Δ-APACHE II scores). |
| Secondary | A change in the total SAPS II score vs. baseline score upon admission | Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay. | The SAPS II score is made of 17 variables: 12 physiology variables, age, type of admission (scheduled surgical, unscheduled surgical, or medical), and three underlying disease variables (acquired immunodeficiency syndrome, metastatic cancer, and hematologic malignancy). The SAPS II score ranges from 0 to 160 points. We evaluate initial SAPS II score and differences between subsequent scores (Δ-SAPS II scores). |
| Secondary | A change in the total MODS score vs. baseline score upon admission | Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay. | MODS (Multiple Organ Dysfunction Score) is composed of scores of six organ systems: R-respiratory, C-cardiovascular, H-hepatic, Co-coagulation, Re-renal, and N-neurological graded from 0 to 4 according to the degree of dysfunction or failure. The MODS score ranges from 0 to 24 points. We evaluate initial MODS score and differences between subsequent scores (MODS scores). |
| Secondary | Concentration of glucose | Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay. | Concentration of glucose (mmol/L) in blood serum after 8-hour fasting. |
| Secondary | Concentration of sodium | Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay. | Concentration of sodium (mmol/L) in blood serum after 8-hour fasting. |
| Secondary | Concentration of potassium | Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay. | Concentration of potassium (mmol/L) in blood serum after 8-hour fasting. |
| Secondary | Concentration of lactate | Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay. | Concentration of lactate (mmol/L) in blood serum after 8-hour fasting. |
| Secondary | Concentration of pyruvate | Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay. | Concentration of pyruvate (mmol/L) in blood serum after 8-hour fasting. |
| Secondary | Concentration of urea | Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay. | Concentration of urea (mmol/L) in blood serum after 8-hour fasting. |
| Secondary | Concentration of creatinine | Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay. | Concentration of creatinine (µmol/L) in blood serum after 8-hour fasting. |
| Secondary | Concentration of bilirubin | Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay. | Concentration of bilirubin (µmol/L) in blood serum after 8-hour fasting. |
| Secondary | Concentration of alanine aminotransferase | Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay. | Concentration of alanine aminotransferase (U/L) in blood serum after 8-hour fasting. |
| Secondary | Concentration of aspartate aminotransferase | Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay. | Concentration of aspartate aminotransferase (U/L) in blood serum after 8-hour fasting. |
| Secondary | Concentration of lactate dehydrogenase | Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay. | Concentration of lactate dehydrogenase (U/L) in blood serum after 8-hour fasting. |
| Secondary | Concentration of alkaline phosphatase | Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay. | Concentration of alkaline phosphatase (U/L) in blood serum after 8-hour fasting. |
| Secondary | Concentration of creatine kinase | Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay. | Concentration of creatine kinase (U/L) in blood serum after 8-hour fasting. |
| Secondary | Concentration of γ-Glutamyltransferase | Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay. | Concentration of γ-Glutamyltransferase (U/L) in blood serum after 8-hour fasting. |
| Secondary | Concentration of low-molecular-weight adiponectin (LMW) | Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay. | Concentration of low-molecular-weight adiponectin (U/L) in blood serum after 8-hour fasting. |
| Secondary | Concentration of middle-molecular-weight adiponectin (MMW) | Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay. | Concentration of middle-molecular-weight adiponectin (U/L) in blood serum after 8-hour fasting. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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