Terlipressin in the treatment of catecholamine-resistant septic shock - Terlipressin in septic shock

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000513-12-CZ

Enrollment

Registered

2007-02-08

Start date

2007-02-15

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Septic shock refractory to standard dose of norepinephrine MedDRA version: 9.1 Level: LLT Classification code 10040070 Term: Septic shock

Interventions

Trade Name: Remestyp 1.0 inj. sol. Product Name: - Product Code: - Pharmaceutical Form: Injection* INN or Proposed INN: TERLIPRESSIN CAS Number: 14636125 Concentration unit: mg/ml milligram(s)/millili

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age >18 years Male or non-pregnant female Refractory septic shock (norepinehprine 0.3 microg/kg/min) with hemodynamic instability (MAP=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnancy Known hypersensitivity to terlipressine Acute coronary artery disease Vasospastic diathesis Acute mesenteric ischemia Epilepsy

Design outcomes

Primary

Measure	Time frame
Main Objective: The trial is designed to evaluate the hemodynamic effects of terlipressin in septic shock patients refractory to standard high dose of norepinephrine.;Secondary Objective: To assess ventilated days, ICU days, and 30 days mortality in patients treated with terlipressin. ;Primary end point(s): We will test the statistical null hypothesis that there is no difference in hemodynamic parameters in those receiving terlipressine compared with those receiving standard treatment (norepinephrine).	—

Measure

Time frame

Main Objective: The trial is designed to evaluate the hemodynamic effects of terlipressin in septic shock patients refractory to standard high dose of norepinephrine.;Secondary Objective: To assess ventilated days, ICU days, and 30 days mortality in patients treated with terlipressin. ;Primary end point(s): We will test the statistical null hypothesis that there is no difference in hemodynamic parameters in those receiving terlipressine compared with those receiving standard treatment (norepinephrine).

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Countries

Czech Republic

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026