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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:
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Inclusion criteria
Criteria of SIRS: at least 2 of 4:
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
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21 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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