Clinical Trial Comparing Noradrenaline (NA) Plus Placebo Versus Noradrenaline Plus Terlipressin (TP) in Septic Shock
NCT ID: NCT05207280
Last Updated: 2023-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
152 participants
INTERVENTIONAL
2022-10-11
2024-11-30
Brief Summary
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This is a clinical trial with the purpose of comparing the efficacy and safety of norepinephrine (NE) plus placebo versus NE plus terlipressin (TP) in adult patients with septic shock and with a Sepsis related Organ Failure Assessment score (SOFA)\> 4 points. The primary objective will be a combined end-point: reduction of organic dysfunction measured at 72 h by SOFA score and by the increase in ICU (Intensive care unit) -free days measured at 28 days.
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Detailed Description
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TP is a synthetic analogue of VP with a long half-life. Preliminary studies on the use of TP associated with NE have not shown a decrease in mortality, although a reduction in organic dysfunction at 72 h, with discordant data regarding the rate of adverse events.
Material and Methods: Randomized, parallel, double-blind and multicenter clinical trial with the purpose of comparing the efficacy and safety of NE plus placebo versus NE plus TP in adult patients with septic shock and with a SOFA score\> 4 points. The threshold dose of NE\> 0.2 µg / kg / min is chosen to associate the second vasopressor (TP or placebo). The primary objective will be a combined end-point: reduction of organic dysfunction measured at 72 h by SOFA score and by the increase in ICU -free days measured at 28 days. The secondary objectives will be: mortality at 28 and 90 days, the need of renal replacement therapies, mechanical ventilation-free days, vasopressor-free days, and adverse reactions. Sample size of 152 patients (76 per arm), stratified by center and severity of illness. In addition, 6 single nucleotide polymorphisms of the vasopressin V1a receptor and a polymorphism of leucyl / cystinyl aminopeptidase or vasopressinase will be determined to establish its association with mortality in septic shock and with the efficacy and the occurrence of adverse effects due to the use of TP.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Noradrenaline plus Terlipressin
Patients enrolled in this arm, will receive noradrenaline with dose equal to or greater than 0.2 μg / Kg / min for at least 3 hours. Solution for infusion (Intravenous). And: Terlipressin with dose 1 mg every 6 hours diluted in a 50 mL serum to pass in 15-30 minutesin injectable solution. Intravenous (diluted in a 50 mL serum to pass in 15-30 minutes)
Noradrenaline plus Terlipressin
Comparison Norepinephrine plus placebo versus Terlipressin plus Norepinephrine for the Treatment of Septic Shock
Noradrenaline plus placebo
Patients enrolled in this arm, will receive noradrenaline with dose equal to or greater than 0.2 μg / Kg / min for at least 3 hours in solution for infusion (Intravenous), and placebo with solution in vial with the same external appearance as terlipressin. 1 mg every 6 hours, diluted in a 50 mL serum to pass in 15-30 minutes in injectable solution Route of administration: Intravenous, diluted in a 50 mL serum to pass in 15-30 minutes
Noradrenaline plus Terlipressin
Comparison Norepinephrine plus placebo versus Terlipressin plus Norepinephrine for the Treatment of Septic Shock
Interventions
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Noradrenaline plus Terlipressin
Comparison Norepinephrine plus placebo versus Terlipressin plus Norepinephrine for the Treatment of Septic Shock
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with septic shock
3. Patients with a SOFA \> 4 points.
5\. Oxygen saturation in the central venous system \> 70% 5. Central venous pressure\> 8 mmHg. 6. Signature of the informed consent by the patient or her legal representative.
Exclusion Criteria
2. Pathologies in which terlipressin is clinically indicated: gastrointestinal bleeding due to esophageal-gastric varices, hepatorenal syndrome.
3. Patients diagnosed with unstable acute coronary syndrome.
4. Patients with acute or chronic mesenteric ischemia.
5. Patients with Raynaud's Phenomenon, or vasospastic disease.
6. Patients participating in another intervention clinical trial.
7. Patients with active bleeding.
8. Patients with renal replacement technique at the time of randomization.
9. Patients with some limitation of life support treatment
10. Previous use of terlipressin during your stay in the intensive Care Unit
18 Years
ALL
No
Sponsors
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Principal Investigators
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José Garnacho Montero
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Virgen Macarena
Locations
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Hospital Universitario Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain
Hospital San Juan de Dios del Aljarafe
Bormujos, Sevilla, Spain
Hospital Puerta del mar
Cadiz, , Spain
Hospital Universitario Reina Sofía
Córdoba, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital Universitario Clínico San Cecilio
Granada, , Spain
Complejo Hospitalario de Jaén
Jaén, , Spain
Hospital Universitario Regional de Málaga
Málaga, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CONTENTSS
Identifier Type: -
Identifier Source: org_study_id
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