Hypertonic Saline and Terlipressin for Sepsis-associated Hypotension

Summary

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)

Timeline

Start

2012-06

Primary completion

2013-12

Completion

2013-12

Drugs

Indications