Trial intelligence / Profile preview

Terlipressin Bolus vs Continuous Drip in Refractory Septic Shock

NCT00793559Phase 2

Key facts

Status
Unknown
Start
Nov 2008
Primary completion
Jul 2009
Countries
1
Sponsor
Shamir Medical Center
Modality
Peptides, Small Molecules
Conditions
septic shock
01

Overview

Phase 2, randomised, open-label trial of terlipressin in septic shock (2 arms), sponsored by Shamir Medical Center. Primary endpoints: Cardiac Index at 6 months, Systemic Vascular Resistance at 6 months and 4 more. Status: unknown.

02

Design

2 arms
Study design
RandomizedOpen-label
  • Terlipressin Bolus

    1 mg terlipressin bolus + SOC (Noradrenaline)

  • Terlipressin Drip

    1 mg terlipressin continuous drip (6h) + SOC (Noradrenaline)

03

Who it enrols

Septic shock patients receiving > 0.5 mcg/kg noradrenaline. Excludes allergy to terlipressin, CHF, IHD, pregnancy.

04

Endpoints

Primary

  • Cardiac Index

  • Systemic Vascular Resistance

  • Heart Rate

  • Blood Pressure

  • Noradrenalin administration

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