NCT00793559

Brief Summary

terlipressin is given to refractory septic shock patients who do not respond to noradrenalin in Israel and Europe. It is given by bolus injection. we attempt to investigate weather it is better to give it by continuous drip and avoid abrupt changes in BP and heart function

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2008

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

November 19, 2008

Status Verified

November 1, 2008

Enrollment Period

8 months

First QC Date

November 18, 2008

Last Update Submit

November 18, 2008

Conditions

Septic Shock

Keywords

septic shock refractory to catecholamines

Outcome Measures

Primary Outcomes (1)

  • CI, SVR,HR,BP, noradrenalin administration,renal function

    6 mo

Study Arms (2)

terlipressin bolus

ACTIVE COMPARATOR

1 mg of terlipressin received one time only

Drug: terlipressin

terlipressin drip

EXPERIMENTAL
Drug: terlipressin

Interventions

terlipressinDRUG

1 mg of terlipressin one time only

Also known as: glypressin
terlipressin bolus

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • septic shock patients receiving above 0.5 mcg/kg NA

You may not qualify if:

  • allergy to terlipressin, CHF, IHD, pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asaf Harofeh MC

Zrifin, 70300, Israel

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Terlipressin

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

LypressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Tal Mann, Dr

    Asaf Harofeh

    STUDY DIRECTOR

Central Study Contacts

Tal Mann, Dr

CONTACT

97257345789tal_mb@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 18, 2008

First Posted

November 19, 2008

Study Start

November 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

November 19, 2008

Record last verified: 2008-11

Locations

IL(1)