Clinical Trial Comparing Noradrenaline (NA) Plus Placebo Versus Noradrenaline Plus Terlipressin (TP) in Septic Shock

NCT05207280 | Unknown Phase 3 DMC

• 1 other identifier: CONTENTSS
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 10

Brief Summary

Septic shock is a major health problem. In the clinical practice guidelines of the Surviving Sepsis Campaign is recommended to add vasopressin (VP) or epinephrine in case of not reaching the goal of mean arterial pressure (MAP) although with a low level of evidence. 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.

Conditions

Septic Shock

Keywords

Septic Shock

Outcome Measures

Primary Outcomes (2)

• Organ failure

  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.

  72 hours

• Days of life free of stay in the Intensive Care Unit

  Number of the days of life free of stay in the Intensive Care Unit measured after the administration of terlipressin / placebo

  28 days

Secondary Outcomes (11)

• Lactate clearance

  6, 12, 24 and 72 hours

• Vasopressor-free days of life

  28 days

• Need of renal replacement therapies

  28 days

• Mechanical ventilation-free days of life

  28 days

• vasopressor index

  28 days

Study Arms (2)

Noradrenaline plus Terlipressin

EXPERIMENTAL

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)

Combination Product: Noradrenaline plus Terlipressin

Noradrenaline plus placebo

PLACEBO COMPARATOR

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

Combination Product: Noradrenaline plus Terlipressin

Interventions

Noradrenaline plus Terlipressin COMBINATION_PRODUCT

Comparison Norepinephrine plus placebo versus Terlipressin plus Norepinephrine for the Treatment of Septic Shock

Also known as: Noradrenaline plus placebo

Noradrenaline plus Terlipressin; Noradrenaline plus placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18 years or older).
• Patients with septic shock
• Patients with a SOFA \> 4 points.
• \. 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.

You may not qualify if:

• Pregnant or lactating patients.
• Pathologies in which terlipressin is clinically indicated: gastrointestinal bleeding due to esophageal-gastric varices, hepatorenal syndrome.
• Patients diagnosed with unstable acute coronary syndrome.
• Patients with acute or chronic mesenteric ischemia.
• Patients with Raynaud's Phenomenon, or vasospastic disease.
• Patients participating in another intervention clinical trial.
• Patients with active bleeding.
• Patients with renal replacement technique at the time of randomization.
• Patients with some limitation of life support treatment
• Previous use of terlipressin during your stay in the intensive Care Unit

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (10)

Hospital Universitario Jerez de la Frontera

Jerez de la Frontera, Cádiz, 11407, Spain

RECRUITING

Hospital San Juan de Dios del Aljarafe

Bormujos, Sevilla, 41930, Spain

RECRUITING

Hospital Puerta del mar

Cadiz, 11009, Spain

RECRUITING

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

RECRUITING

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

RECRUITING

Hospital Universitario Clínico San Cecilio

Granada, 18016, Spain

RECRUITING

Complejo Hospitalario de Jaén

Jaén, 23007, Spain

RECRUITING

Hospital Universitario Regional de Málaga

Málaga, 29010, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Interventions

Norepinephrine; Terlipressin

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• José Garnacho Montero

  Hospital Universitario Virgen Macarena

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clara Rosso Fernández

CONTACT

955012144; claram.rosso.sspa@juntadeandalucia.es

Irene Borreguero Borreguero

CONTACT

955007609; irene.borreguero@juntadeandalucia.es

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind clinical trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, parallel, multicenter, double-blind clinical trial with two treatment arms

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: January 26, 2022
• Study Start: October 11, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10)