Using terlipressin to treat patients with refractory septic shock
Terlipressin Versus Placebo for Septic Shock Refractory to High Doses Catecholamine Vasopressors: A Randomized-controlled Trial
PHASE2 · Mahidol University · NCT04339868
This study is testing if adding terlipressin to standard treatments can help people with severe septic shock who haven't responded well to other medications.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mahidol University (other) |
| Locations | 1 site (Bangkok) |
| Trial ID | NCT04339868 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of terlipressin, a selective V1 receptor agonist, in patients experiencing refractory septic shock who have not responded adequately to high doses of norepinephrine and/or epinephrine. The study aims to determine if combining terlipressin with these traditional vasopressors can improve blood pressure management while reducing the side effects associated with high adrenergic stimulation. Participants must meet specific criteria related to their septic shock condition and prior treatments. The trial will compare the effects of terlipressin against a placebo to assess its potential benefits.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with septic shock who have received high doses of norepinephrine and/or epinephrine but continue to have low blood pressure.
Not a fit: Patients who are terminally ill, have certain severe comorbidities, or have been diagnosed with septic shock for more than 48 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and safer option for managing refractory septic shock.
How similar studies have performed: While the use of terlipressin in this context is relatively novel, previous studies have shown promising results with similar vasopressor approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Septic shock according to Sepsis-3 definition * Evidence of adequate fluid * Received norepinephrine 0.2 mcg/kg/min or more * Received norepinephrine plus epinephrine (any dose) * Mean arterial lower than 65 mmHg or lactate \> 2 mmol/liter Exclusion Criteria: 1. Septic shock diagnosis \> 48 hours before 2. Receive intravenous fluid \< 30 mL/kg before enrollment 3. Do-not-resuscitation and terminally ill 4. Refractory to treatment malignancy 5. Pregnancy 7. Chronic renal failure stage 5 with no plan for long term renal replacement therapy 8. Cirrhosis child C 9. Cardiogenic shock 10. Acute decompensated heart failure 11. Evidence of left ventricular ejection fraction (LVEF) \< 35% 12. Acute coronary syndrome within 72 hours 13. Severe valvular heart disease 14. Documented life-threatening tachyarrhythmia before enrollment 15. Diagnosis of acute mesenteric ischemia before enrollment 16. Previous diagnosis of Raynaud's phenomenon 17. Known peripheral arterial disease 18. Refuse to sign the informed consent by patient or representative
Where this trial is running
Bangkok
- Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University — Bangkok, Thailand (RECRUITING)
Study contacts
- Principal investigator: Surat Tongyoo, MD — Mahidol University
- Study coordinator: Surat Tongyoo, MD
- Email: surat.ton@mahidol.ac.th
- Phone: 0820137771
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Septic Shock, Refractory Shock, Norepinephrine Adverse Reaction