deltatrials
Completed PHASE2 INTERVENTIONAL 3-arm NCT00481572

Continuous Infusion of Terlipressin in Septic Shock

Continuous Terlipressin Versus Vasopressin Infusion in Septic Shock. A Randomized, Controlled, Pilot Trial. THE TERLIVAP STUDY

Sponsor: University of Roma La Sapienza

Conditions Septic Shock
Updated 6 times since 2017 Last updated: Feb 26, 2008 Started: Jan 31, 2007 Primary completion: Dec 31, 2007 Completion: Dec 31, 2007
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Septic Shock and is currently completed. University of Roma La Sapienza leads this study, which shows 6 recorded versions since 2007 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

Forty-five septic shock patients requiring vasopressor support to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation were enrolled in the study. Patients were randomly allocated to be treated with either a) a continuous terlipressin infusion (1.3 µg•kg-1), b) vasopressin (0.03 U•min-1), or c) titrated norepinephrine (control; each n = 15). In both the terlipressin and vasopressin group, norepinephrine was additionally administered to achieve a mean arterial pressure (MAP) between 65 and 75 mmHg, if necessary. Data from right heart catheterization, thermo-dye dilution catheter, gastric tonometry as well as data from organ function, cytokines concentrations, were obtained at baseline and after 12, 24, 36 and 48 hours.

Forty-five septic shock patients requiring vasopressor support to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation were enrolled in the study. Patients were randomly allocated to be treated with either a) a continuous terlipressin infusion (1.3 µg•kg-1), b) vasopressin (0.03 U•min-1), or c) titrated norepinephrine (control; each n = 15). In both the terlipressin and vasopressin group, norepinephrine was additionally administered to achieve a mean arterial pressure (MAP) between 65 and 75 mmHg, if necessary. Data from right heart catheterization, thermo-dye dilution catheter, gastric tonometry as well as data from organ function, cytokines concentrations, were obtained at baseline and after 12, 24, 36 and 48 hours.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

Show 1 earlier version
  1. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE2

    First recorded

Jan 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • University of Roma La Sapienza
Data source: University of Roma La Sapienza

For direct contact, visit the study record on ClinicalTrials.gov .