Trial · NCT03829683
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Model for End Stage Liver Disease (MELD) Score | Baseline and 96 hours | Change in MELD score from Day 0 to Day 4. MELD score ranges from 6 (least sick) to 40 (most sick) based on blood tests which ranks the degree of sickness from liver disease. The lab tests used to determine the MELD score are creatinine, bilirubin, and international normalized ratio (INR). |
| Secondary | Change in Chronic Liver Failure-Sequential Organ Failure Assessment (CLIF-SOFA) Score | Baseline and 96 hours | A number that ranges from 0 (least sick) to 24 (most sick) and ranks the degree of sickness from liver failure and several other organ systems in a critically ill person. The score is determined by evaluating a person's liver function, kidney function, nervous system (brain), coagulation (blood clotting), circulation (blood pressure), and respiratory status (breathing) |
| Secondary | Change in Aspartate Aminotransferase (AST) Level | Baseline and 96 hours | Standard blood test used to determine the severity and nature of liver problems. |
| Secondary | Change in Alanine Aminotransferase (ALT) Level | Baseline and 96 hours | Standard blood test used to determine the severity and nature of liver problems. |
| Secondary | Change in Total Bilirubin | Baseline and 96 hours | Standard blood test used to determine the severity and nature of liver problems. |
| Secondary | Change in Alkaline Phosphatase | Baseline and 96 hours | Standard blood test used to determine the severity and nature of liver problems. |
| Secondary | Change in Albumin | Baseline and 96 hours | Standard blood test used to determine the severity and nature of liver problems. |
| Secondary | Number of Treatment-related Adverse Events as Assessed by CTCAE v5.0 | up to 96 hours | Observation about the need to change the dose of study medication and symptoms such as headache, dizziness, dry mouth, nausea, vomiting, flushing, rash, or hypotension (low blood pressure) |
| Secondary | Changes to Corrected QT Interval (QTc) | Baseline and 96 hours | An electrocardiogram (ECG or test of the electrical activity of the heart) is performed to determine if there are changes to the heart rhythm. |
| Secondary | Changes to Urine pH | Baseline and 96 hours | Urine samples are collected to determine changes in pH (acidity) that could indicate a risk for kidney stones. The pH scale ranges from 0 to 14, with smaller numbers meaning more acidic and higher numbers meaning more basic. A pH of 7 is considered to be neutral. Normal levels of urine pH range from 4.6 - 8 on the pH scale. |
| Secondary | Changes to Urine Microscopy | Baseline and 96 hours | Urine samples are collected to check for the presence of crystalluria (microscopic crystals) that could indicate a risk for kidney stones. |
| Secondary | Changes to Level of Medical Care | up to 168 hours | Documentation of the need for more intensive medical care such as ventilator (breathing machine) or vasopressors (intravenous medications use increase blood pressure) when not needed at baseline |
| Secondary | ICU-free Days | Day 28 | The number of days not spent in an intensive care unit (ICU) |
| Secondary | Number of Deaths Due to Any Cause | Day 28 | Any cause of death that is anticipated or unanticipated |
| Secondary | Number of Deaths Due to Any Cause | Day 90 | Any cause of death that is anticipated or unanticipated |
| Secondary | Hospital-free Days | Day 90 | The number of days spent outside of the hospital |
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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