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Double blind randomized clinical trial comparing noradrenaline plus placebo versus noradrenaline plus terlipressin in septic shock.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514149-12-00
Acronym
CONTENTSS
Enrollment
152
Registered
2024-06-04
Start date
2024-06-26
Completion date
2024-12-28
Last updated
2024-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Brief summary

Reduction of organ failure evaluated by SOFA scale, Increase in ICU-free days of life

Detailed description

Increase in lactate clearance., Increase of the days with life free of mechanical ventilation., Increase in vasopressor-free days of life, Mortality, Reduction of the need for continuous renal replacement therapy (CRRT)., Reduction of the total equivalent dose of vasopressors, No increase in adverse effects related to the administration of vasopressors, Association of mortality with genetic variants of the vasopressin 1a receptor and the LNPEP gene., Association between the achievement of the combined primary endpoint and the genetic variants of the vasopressin receptor 1a and the LNPEP gene., Association between the appearance of adverse effects due to the use of terlipressin, and the genetic variants of the Vasopressin 1a receptor and LNPEP gene.

Interventions

DRUGNOREPINEPHRINE
DRUGTerlipresina acetato EVER Pharma 1 mg solución inyectable
DRUGSolution in a vial with the same external appearance as terlipressin

Sponsors

Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Reduction of organ failure evaluated by SOFA scale, Increase in ICU-free days of life

Secondary

MeasureTime frame
Increase in lactate clearance., Increase of the days with life free of mechanical ventilation., Increase in vasopressor-free days of life, Mortality, Reduction of the need for continuous renal replacement therapy (CRRT)., Reduction of the total equivalent dose of vasopressors, No increase in adverse effects related to the administration of vasopressors, Association of mortality with genetic variants of the vasopressin 1a receptor and the LNPEP gene., Association between the achievement of the combined primary endpoint and the genetic variants of the vasopressin receptor 1a and the LNPEP gene., Association between the appearance of adverse effects due to the use of terlipressin, and the genetic variants of the Vasopressin 1a receptor and LNPEP gene.

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026