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

Primary Purpose

Septic Shock, Sepsis-associated Hypotension

Status

Terminated

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Hypertonic Saline and Terlipressin

Normal saline and norepinephrine

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital General de Ciudad Real

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hypertonic Saline and Terlipressin

Normal Saline and norepinephrine

Arm Description

Outcomes

Primary Outcome Measures

MOD (Multiple Organ Dysfunction) Score

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT01271114

First Posted

January 4, 2011

Last Updated

March 7, 2014

Sponsor

Hospital General de Ciudad Real

Collaborators

University of Castilla-La Mancha

1. Study Identification

Unique Protocol Identification Number

NCT01271114

Brief Title

Hypertonic Saline and Terlipressin for Sepsis-associated Hypotension

Acronym

HYSATESS-p

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 Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Terminated

Why Stopped

Low recruitment rate

Study Start Date

June 2012 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital General de Ciudad Real

Collaborators

University of Castilla-La Mancha

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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: 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Septic Shock, Sepsis-associated Hypotension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hypertonic Saline and Terlipressin

Arm Type

Experimental

Arm Title

Normal Saline and norepinephrine

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Hypertonic Saline and Terlipressin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Normal saline and norepinephrine

Intervention Description

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

Primary Outcome Measure Information:

Title

MOD (Multiple Organ Dysfunction) Score

Time Frame

daily, as long as the patient stays in the ICU

Secondary Outcome Measure Information:

Title

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

Time Frame

First 48 hours

Title

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

Title

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

Title

Hypertonic Saline associated with terlipressin normalizes blood pressure in septic shock

Time Frame

First 48 hours

Title

Hypertonic Saline boluses increases plasma levels of vasopressin (AVP)

Time Frame

First week in ICU

Title

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

Time Frame

First week in ICU

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Javier Pascual Ramírez

Organizational Affiliation

HGCR

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Luis COLLAR VIÑUELAS, MD

Organizational Affiliation

HGCR

Official's Role

Study Chair

Facility Information:

Facility Name

Hospital General de Ciudad Real

City

Ciudad Real

ZIP/Postal Code

13005

Country

Spain

12. IPD Sharing Statement

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Hypertonic Saline and Terlipressin for Sepsis-associated Hypotension

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