Hypertonic Saline and Terlipressin for Sepsis-associated Hypotension (HYSATESS-p)

Hospital General de Ciudad Real

Status and phase: Terminated; Phase 3

Conditions: Sepsis-associated Hypotension; Septic Shock

Treatments: Drug: Normal saline and norepinephrine; Drug: Hypertonic Saline and Terlipressin

Study type: Interventional

Funder types: Other

Identifiers

NCT01271114

FISCAM AN-2010/28

2010-024138-43 (EudraCT Number)

Details and patient eligibility

About

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)

Enrollment: 21 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Criteria of SIRS: at least 2 of 4:

  • Temperature > 38 °c or < 36 ° C
  • More than 90 bpm heart rate
  • Respiratory rate more than 20rpm or PaCO2 less than 32 mm Hg or patient in mechanical ventilation
  • Less than 4000/ mm³ or more than 12000/mm³, or more than 10% leukocyte bands (immature)

• Septic source known demonstrated (or at least of high probability) and controlled (if it is controllable)

• Hematocrit 25% or higher and/or hemoglobin 8 g/dL or higher. If necessary, transfuse RBCs to meet this criteria

• MAP less than 70 mm Hg. Note there is no requirement for adequate preload evidence

Exclusion criteria

• Hypernatremia at base-line of 155 mEq/L or greater Hyponatremia at base-line less than 130mEq / L
• Prior endocrine disease affecting to the adrenal-pituitary axis.
• Intracranial Hypertension, brain tumor, seizures, head trauma
• Coronary Artery Disease active over the past year; or evidence of "myocardium at risk" by exercise stress test, pharmacological or positive gammagraphy last year without intervention
• Pregnancy
• Liver disease Child C, End-Stage-Renal-Disease
• Under the age of 18
• Patients with order "do not resuscitate" or with minimal chances to survive

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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21 participants in 2 patient groups

Hypertonic Saline and Terlipressin

Experimental group

Treatment:

Drug: Hypertonic Saline and Terlipressin

Normal Saline and norepinephrine

Active Comparator group

Treatment:

Drug: Normal saline and norepinephrine