Trial · NCT05207280
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Organ failure | 72 hours | Number of organ failures related sepsis. Assessment Sepsis related Organ Failure Assessmen scale (SOFA scale) after administration of terlipressin / placebo. These scale assesses organ dysfunction. In patients with infection, a SOFA score ≥ 2 points (in patients with chronic organ dysfunction, a 2 point increase from baseline score) is diagnostic of sepsis. |
| Primary | Days of life free of stay in the Intensive Care Unit | 28 days | Number of the days of life free of stay in the Intensive Care Unit measured after the administration of terlipressin / placebo |
| Secondary | Lactate clearance | 6, 12, 24 and 72 hours | Measure of the difference between lactate in arterial blood measured at the beginning of vasopressor treatment and that measured at 6, 12, 24 and 72 hours. |
| Secondary | Vasopressor-free days of life | 28 days | Measure of vasopressor-free days of life |
| Secondary | Need of renal replacement therapies | 28 days | Assessment of the change in the need of renal replacement therapies |
| Secondary | Mechanical ventilation-free days of life | 28 days | Measure of days free of mechanical ventilation, by means of the difference between 28 and the sum of the days the patient is under invasive mechanical ventilation or has died. |
| Secondary | vasopressor index | 28 days | Calculation of the vasopressor index, defined as dose of dopamine + dose of dobutamine + dose of epinephrine (x100) + dose of phenylephrine (x100) + dose of terlipressin / placebo. |
| Secondary | Mortality | 28 days | Evaluation of the number of patients who die from the signing of the informed consent until day 28 |
| Secondary | Mortality | 90 days | Evaluation of the number of patients who die from the signing of the informed consent until day 90 |
| Secondary | Adverse effects related to the administration of vasopressors | 90 days | Measure of the adverse effects related to the administration of vasopressors until the end of study |
| Secondary | Relation between organ failure and days of life free of stay in the Intensive Care Unit with the genetic variants of the receptor 1a and LNPEP | 90 days | Measure of the relation between number of organ failures related sepsis and number of the days of life free of stay in the Intensive Care Unit with the genetic variants of the vasopressin receptor 1a and LNPEP |
| Secondary | Relation between the appearance of adverse effects and genetic variants of the receptor 1a and LNPEP. | 90 days | Measure of the relation between adverse effects due to the use of terlipressin and genetic variants of the vasopressin receptor 1a and LNPEP |
| Secondary | Relation of the mortality with genetic variants of the receptor 1a and LNPEP. | 90 days | Measure of the relation between the mortality with genetic variants of the vasopressin receptor 1a and LNPEP |
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.
For software
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