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Hypertonic Saline and Terlipressin for Sepsis-associated Hypotension

Information source: Hospital General de Ciudad Real
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Septic Shock; Sepsis-associated Hypotension

Intervention: Hypertonic Saline and Terlipressin (Drug); Normal saline and norepinephrine (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Hospital General de Ciudad Real

Official(s) and/or principal investigator(s):
Javier Pascual Ramírez, Principal Investigator, Affiliation: HGCR
Luis COLLAR VIÑUELAS, MD, Study Chair, Affiliation: HGCR

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)

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: MOD (Multiple Organ Dysfunction) Score

Secondary outcome:

Hypertonic Saline restores IV fluid response parameters (Pulse Pressure Variation or Systolic Volume Variation) adequately

Hypertonic Saline associated with terlipressin maintains plasma sodium levels 130-155mEq/L

There is an inverse relationship between plasma sodium and plasma procalcitonin levels measured by a negative Pearson coefficient

Hypertonic Saline associated with terlipressin normalizes blood pressure in septic shock

Hypertonic Saline boluses increases plasma levels of vasopressin (AVP)

Hypertonic Saline use rises levels of cortisol but not of adrenocorticotropic hormone (ACTH)

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Hospital General de Ciudad Real, Ciudad Real 13005, Spain
Additional Information

Starting date: June 2012
Last updated: March 7, 2014

Page last updated: August 23, 2015

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