NCT01271114

Hypertonic Saline and Terlipressin for Sepsis-associated Hypotension

Hypertonic Saline and Terlipressin Linked To an Early Goal-Driven Protocol for Septic Shock or Sepsis-Associated Hypotension: A Pilot Trial (HYSATESS)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Hospital General de Ciudad Real · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Septic Shock
• Sepsis-associated Hypotension

Interventions

Type	Name	Description
DRUG	Hypertonic Saline and Terlipressin	Hypertonic saline 3% 7mL/Kg (with a maximum 500 mL)triggered by either Systolic Volume Variation or Pulse Pressure Variation more than 10%; Terlipressin infusion (dilution 1mg in 100mL) triggered by MAP below 70 mmHg for a goal MAP above 70 mmHg
DRUG	Normal saline and norepinephrine	Normal saline IV bolus 7mL/kg (with a maximum 500 mL)triggered by either Systolic Volume Variation or Pulse Pressure Variation above 10%; Norepinephrine drip (80 micrograms/mL) to keep MAP at least 70 mmHg

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-01-06
• Last updated: 2014-03-10

Locations

1 site across 1 country: Spain