Terlipressin for Refractory Septic Shock

Launched by MAHIDOL UNIVERSITY · Apr 7, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a medication called terlipressin for patients who are experiencing septic shock that does not respond to standard treatments. Septic shock is a serious condition where the body has a severe reaction to an infection, leading to dangerously low blood pressure. Usually, doctors start by giving a medication called norepinephrine to help raise blood pressure. If that doesn't work, they might try epinephrine or vasopressin. This trial is looking at whether terlipressin, used alongside norepinephrine and/or epinephrine, can help improve blood pressure more effectively and with fewer side effects.

To participate in the study, patients should be between the ages of 65 and 74 and must have septic shock that meets specific criteria, including having received a certain amount of norepinephrine. However, there are some conditions that would exclude someone from participating, such as being too ill or having certain heart or kidney problems. If eligible, participants can expect to receive careful monitoring and treatment to see how well terlipressin works in combination with other medications for their condition. This trial is currently recruiting participants and aims to find new ways to help manage this critical health issue.

Gender

ALL

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:
• • 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