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

This study has been terminated.
(Low recruitment rate)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01271114
First Posted: January 6, 2011
Last Update Posted: March 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Castilla-La Mancha
Information provided by (Responsible Party):
Javier Pascual-Ramirez, Hospital General de Ciudad Real
  Purpose

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)

Condition Intervention Phase
Septic Shock Sepsis-associated Hypotension Drug: Hypertonic Saline and Terlipressin Drug: Normal saline and norepinephrine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hypertonic Saline and Terlipressin Linked To an Early Goal-Driven Protocol for Septic Shock or Sepsis-Associated Hypotension: A Pilot Trial (HYSATESS)

Resource links provided by NLM:


Further study details as provided by Javier Pascual-Ramirez, Hospital General de Ciudad Real:

Primary Outcome Measures:
  • MOD (Multiple Organ Dysfunction) Score [ Time Frame: daily, as long as the patient stays in the ICU ]

Secondary Outcome Measures:
  • Hypertonic Saline restores IV fluid response parameters (Pulse Pressure Variation or Systolic Volume Variation) adequately [ Time Frame: First 48 hours ]
  • 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 ]
  • 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 ]
  • Hypertonic Saline associated with terlipressin normalizes blood pressure in septic shock [ Time Frame: First 48 hours ]
  • Hypertonic Saline boluses increases plasma levels of vasopressin (AVP) [ Time Frame: First week in ICU ]
  • Hypertonic Saline use rises levels of cortisol but not of adrenocorticotropic hormone (ACTH) [ Time Frame: First week in ICU ]

Enrollment: 21
Study Start Date: June 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hypertonic Saline and Terlipressin 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
Active Comparator: Normal Saline and norepinephrine 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

  Eligibility

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01271114


Locations
Spain
Hospital General de Ciudad Real
Ciudad Real, Spain, 13005
Sponsors and Collaborators
Hospital General de Ciudad Real
University of Castilla-La Mancha
Investigators
Principal Investigator: Javier Pascual Ramírez HGCR
Study Chair: Luis COLLAR VIÑUELAS, MD HGCR
  More Information

Responsible Party: Javier Pascual-Ramirez, MD, Hospital General de Ciudad Real
ClinicalTrials.gov Identifier: NCT01271114     History of Changes
Other Study ID Numbers: FISCAM AN-2010/28
2010-024138-43 ( EudraCT Number )
First Submitted: January 4, 2011
First Posted: January 6, 2011
Last Update Posted: March 10, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock, Septic
Hypotension
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Vascular Diseases
Cardiovascular Diseases
Norepinephrine
Terlipressin
Lypressin
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Antihypertensive Agents
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents