Septic ShockPhase 3HYSATESS-pNCT01271114
Hypertonic Saline and Terlipressin for Sepsis-associated Hypotension
A Phase 3 study testing Hypertonic Saline and Terlipressin and Normal saline and norepinephrine in people with Septic Shock and Sepsis-associated Hypotension, run by Hospital General de Ciudad Real at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Septic Shock, Sepsis-associated Hypotension
- What is being tested?
- Hypertonic Saline and Terlipressin and Normal saline and norepinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2012to Dec 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Hypertonic Saline and Terlipressin Linked To an Early Goal-Driven Protocol for Septic Shock or Sepsis-Associated Hypotension: A Pilot Trial (HYSATESS)
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.
Read more
Other goals of the pilot study:
- HS restores preload parameters adequately
- HS associated with terlipressin normalizes blood pressure in septic shock
- HS associated with terlipressin maintains plasma sodium levels 130-155mEq/L
- There is an inverse relationship between plasma sodium and procalcitonin levels
- HS increases plasma levels of vasopressin (AVP)
- HS rises levels of cortisol but not of adrenocorticotropic hormone (ACTH)
- Conditions
- Septic Shock, Sepsis-associated Hypotension
- Being tested
- Hypertonic Saline and Terlipressin, Normal saline and norepinephrine
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic Saline and TerlipressinDrug
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
Normal saline and norepinephrineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Hypertonic Saline and Terlipressin | Experimental | Not described Receives: Drug: Hypertonic Saline and Terlipressin |
| Normal Saline and norepinephrine | Active comparator | Not described Receives: Drug: Normal saline and norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
MOD (Multiple Organ Dysfunction) Score
Measured: daily, as long as the patient stays in the ICU
Secondary outcomes (6)
Hypertonic Saline restores IV fluid response parameters (Pulse Pressure Variation or Systolic Volume Variation) adequately
Measured: First 48 hours
Hypertonic Saline associated with terlipressin maintains plasma sodium levels 130-155mEq/L
Measured: 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
Measured: As long as the patient stays in the ICU
Hypertonic Saline associated with terlipressin normalizes blood pressure in septic shock
Measured: First 48 hours
Hypertonic Saline boluses increases plasma levels of vasopressin (AVP)
Measured: First week in ICU
Hypertonic Saline use rises levels of cortisol but not of adrenocorticotropic hormone (ACTH)
Measured: First week in ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2011 (estimated)
- Study startJun 2012
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General de Ciudad Real
- Sponsor type
- University, hospital or other
- Collaborators
- University of Castilla-La Mancha
- Responsible party
- Principal investigator, Javier Pascual-Ramirez, Hospital General de Ciudad Real
- Investigators
- Javier Pascual Ramírez, Principal investigator, HGCRLuis COLLAR VIÑUELAS, MD, Study chair, HGCR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271114
- Sponsor's protocol ID
- FISCAM AN-2010/28
- Other IDs
- 2010-024138-43
- Acronym
- HYSATESS-p
- Status last verified
- Mar 2014
- First submitted
- 4 Jan 2011
- Last updated
- 10 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertonic Saline and Terlipressin Linked To an Early Goal-Driven Protocol for Septic Shock or Sepsis-Associated Hypotension: A Pilot Trial (HYSATESS)
- ClinicalTrials.gov ID
- NCT01271114
- Acronym / sponsor ID
- HYSATESS-p / FISCAM AN-2010/28
- Conditions
- Septic Shock, Sepsis-associated Hypotension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment rate
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hospital General de Ciudad RealUniversity, hospital or other
- Collaborators
- University of Castilla-La Mancha
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- HS restores preload parameters adequately
- HS associated with terlipressin normalizes blood pressure in septic shock
- HS associated with terlipressin maintains plasma sodium levels 130-155mEq/L
- There is an inverse relationship between plasma sodium and procalcitonin levels
- HS increases plasma levels of vasopressin (AVP)
- HS rises levels of cortisol but not of adrenocorticotropic hormone (ACTH)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertonic Saline and Terlipressin | Experimental | Drug: Hypertonic Saline and Terlipressin |
| Normal Saline and norepinephrine | Active comparator | Drug: Normal saline and norepinephrine |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypertonic Saline and TerlipressinHypertonic 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 | Drug | Hypertonic Saline and Terlipressin |
| Normal saline and norepinephrineNormal 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 | Drug | Normal Saline and norepinephrine |
Primary outcome
MOD (Multiple Organ Dysfunction) Score
Time frame: daily, as long as the patient stays in the ICU
6 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2014.
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Pascual Ramírez principal investigator
HGCR
Luis COLLAR VIÑUELAS, MD study chair
HGCR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hypertonic Saline and Terlipressin and Normal saline and norepinephrine in people with Septic Shock and Sepsis-associated Hypotension, run by Hospital General de Ciudad Real at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low recruitment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MOD (Multiple Organ Dysfunction) Score (time frame: daily, as long as the patient stays in the ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2014.