Septic Shock Clinical Trial
Official title:
Hypertonic Saline and Terlipressin Linked To an Early Goal-Driven Protocol for Septic Shock or Sepsis-Associated Hypotension: A Pilot Trial (HYSATESS)
In hypotensive septic patients with controlled source, an hemodynamic management protocol
including hypertonic saline (HS)and terlipressin improves MOD (Multiple Organ Dysfunction)
Score by at least 3 points compared to the use of physiologic saline and norepinephrine.
The appropriate design for this trial would be factorial. For the time being, will consider
de intervention as a whole unit for this pilot study. In the future an appropriately sized
factorial multicentric study shall be necessary.
Other goals of the pilot study:
1. HS restores preload parameters adequately
2. HS associated with terlipressin normalizes blood pressure in septic shock
3. HS associated with terlipressin maintains plasma sodium levels 130-155mEq/L
4. There is an inverse relationship between plasma sodium and procalcitonin levels
5. HS increases plasma levels of vasopressin (AVP)
6. HS rises levels of cortisol but not of adrenocorticotropic hormone (ACTH)
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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