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Terlipressin for Refractory Septic Shock

NCT04339868 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2021-09-24

No results posted yet for this study

Summary

Norepinephrine was recommended as the first vasopressor for septic shock resuscitation.

For the patient who did not response to high dose norepinephrine, epinephrine was recommended.

Vasopressin was also recommended as an alternative vasopressor, in case patient did not response to norepinephrine and or epinephrine.

Terlipressin, a selective V1 receptor binding with long half life, was reported that it main action is to increase blood pressure via the different mechanism from norepinephrine and epinephrine.

To use terlipressin, combine with norepinephrine and or epinephrine among refractory septic shock, could decrease the usage dose of norepinephrine and epinephrine as well as lower the side effects of too high adrenergic stimuli.

Conditions

  • Septic Shock
  • Refractory Shock
  • Norepinephrine Adverse Reaction

Interventions

DRUG

Terlipressin

Terlipressin (20-100 mcg/hr) plus norepinephrine and/or epinephrine

DRUG

Placebo

0.9% NaCl plus norepinephrine and/or epinephrine

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Surat Tongyoo, MD · Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-03
Primary Completion
2025-03-31
Completion
2025-07-31

Countries

  • Thailand

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04339868 on ClinicalTrials.gov