CClinicalTrials.gg
Sign In
TerminatedNCT01271114HYSATESS-pUpdated Mar 10, 2014

Hypertonic Saline and Terlipressin for Sepsis-associated Hypotension

A Phase 3 interventional study of Hypertonic Saline and Terlipressin and Normal saline and norepinephrine in Septic Shock and Sepsis-associated Hypotension, sponsored by Hospital General de Ciudad Real. Terminated at 1 site in Spain. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2014-03-10.

Sponsored by Hospital General de Ciudad Real · Phase 3, Interventional, and Treatment

Why this study was terminated
Low recruitment rate
Phase
Phase 3
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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)
02

Conditions studied

  • Septic Shock
  • Sepsis-associated Hypotension
03

In context

Sepsis

1,894 studies on the registry are indexed under Sepsis; 458 are open to participants now.

This study's enrollment of 21 is below the median of 105 across 893 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Hospital General de Ciudad Real is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    Hypertonic Saline and Terlipressin

    Drug: Hypertonic Saline and Terlipressin

  • Active comparator
    Normal Saline and norepinephrine

    Drug: Normal saline and norepinephrine

Interventions

  • DrugHypertonic 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

  • DrugNormal 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

06

What researchers measure

Primary outcomes

  1. MOD (Multiple Organ Dysfunction) Score

    Time frame: daily, as long as the patient stays in the ICU

Secondary outcomes

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

    Time frame: First 48 hours

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

    Time frame: As long as Hypertonic saline plus terlipressin are in use and one week later

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

    Time frame: As long as the patient stays in the ICU

  4. Hypertonic Saline associated with terlipressin normalizes blood pressure in septic shock

    Time frame: First 48 hours

  5. Hypertonic Saline boluses increases plasma levels of vasopressin (AVP)

    Time frame: First week in ICU

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

    Time frame: First week in ICU

07

Study locations

1 site
  • Hospital General de Ciudad Real
    Ciudad Real, 13005, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01271114
Lead sponsor
Hospital General de Ciudad Real
Collaborators
University of Castilla-La Mancha
Responsible party
Javier Pascual-Ramirez (MD, Hospital General de Ciudad Real) — Principal investigator
First posted
Jan 6, 2011
Start date
Jun 2012
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Mar 10, 2014

Study contacts

Javier Pascual Ramírez
principal investigator · HGCR
Luis COLLAR VIÑUELAS, MD
study chair · HGCR

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Sepsis→

Other studies from this sponsor

Hospital General de Ciudad Real

Start the discussion