Terlipressin for Refractory Septic Shock (TERESEP)
Septic Shock, Refractory Shock, Norepinephrine Adverse Reaction
About this trial
This is an interventional treatment trial for Septic Shock
Eligibility 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:
- Septic shock diagnosis > 48 hours before
- Receive intravenous fluid < 30 mL/kg before enrollment
- Do-not-resuscitation and terminally ill
- Refractory to treatment malignancy
- 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
Sites / Locations
- Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Terlipressin group
Placebo group
Terlipressin acetate 1 mg in 0.9% normal saline (NaCl) 50 mL (0.02 mg/mL) Initial dose 20 mcg/hr (1 mL/hr) titrate increase 1 mL/hr every 30 min to 100 mcg/hr (5 mg/hr) to keep mean arterial blood pressure (MAP) > 65 mmHg If MAP > 75 mmHg for > 30 min, decrease epinephrine and norepinephrine until < 0.15 mcg/kg/min, then decrease terlipressin until stop
Placebo 0.9% NaCl 50 mL Initial dose 1 mL/hr titrate increase 1 mL/hr every 30 min to 5 mg/hr to keep mean arterial blood pressure (MAP) > 65 mmHg If MAP > 75 mmHg for > 30 min, decrease epinephrine and norepinephrine until < 0.15 mcg/kg/min, then decrease placebo until stop