NCT00481572

Brief Summary

The purpose of this study is to determine whether: A)the continuous infusion ultra-low dose of terlipressin (1.3 micrograms/kg/h) is able to stabilize hemodynamic in patients with septic shock, reducing the risk of adverse effects related to the bolus dose.B)the continuous infusion ultra-low dose of terlipressin may be use in lieu of vasopressin.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

February 29, 2008

Status Verified

February 1, 2008

Enrollment Period

11 months

First QC Date

May 30, 2007

Last Update Submit

February 26, 2008

Conditions

Septic Shock

Keywords

SepsisSeptic Shockvasopressinterlipressin

Outcome Measures

Primary Outcomes (1)

  • Systemic and regional hemodynamics

    during the first 48 hours from the onset of septic shock

Secondary Outcomes (1)

  • Markers of inflammation,organ functions,adverse effects.

    during the first 48 hours from the onset of septic shock

Study Arms (3)

1

EXPERIMENTAL

Terlipressin

Drug: Terlipressin

2

EXPERIMENTAL

Vasopressin

Drug: Vasopressin

3

ACTIVE COMPARATOR

titrated norepinephrine

Drug: Norepinephrine

Interventions

TerlipressinDRUG

continuous terlipressin infusion 1.3 µg•kg-1 over a period of 48 hrs

1
VasopressinDRUG

continuous intravenous infusion of vasopressin 0.03 U•min-1 over a period of 48 hrs

2
NorepinephrineDRUG

titrated norepinephrine over a period of 48 hrs

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Septic shock
  • vasopressor support to maintain mean arterial pressure (MAP) between 65 and 75 mmHg despite adequate volume resuscitation (pulmonary artery occlusion pressure = 13-18 mmHg and central venous pressure = 8-12 mmHg)

You may not qualify if:

  • Pregnancy
  • Present cardiac dysfunction
  • Present or suspected acute mesenteric ischemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive care of the University of Rome "La Sapienza"

Rome, Viale Del Policlinico 155, 00161, Italy

Location

Related Publications (1)

  • Morelli A, Ertmer C, Rehberg S, Lange M, Orecchioni A, Cecchini V, Bachetoni A, D'Alessandro M, Van Aken H, Pietropaoli P, Westphal M. Continuous terlipressin versus vasopressin infusion in septic shock (TERLIVAP): a randomized, controlled pilot study. Crit Care. 2009;13(4):R130. doi: 10.1186/cc7990. Epub 2009 Aug 10.

    PMID: 19664253DERIVED

MeSH Terms

Conditions

Shock, SepticSepsisDiabetes Insipidus

Interventions

TerlipressinVasopressinsNorepinephrine

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

LypressinPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Andrea Morelli, MD

    Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza"

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 30, 2007

First Posted

June 1, 2007

Study Start

January 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

February 29, 2008

Record last verified: 2008-02

Locations

IT(1)