Terlipressin for Refractory Septic Shock

• Status: Recruiting
• Trial end date: 2025-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mahidol University
• Treatments: Epinephrine; Epinephryl borate; Norepinephrine; Racepinephrine; Terlipressin

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