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Hypertonic Saline and Terlipressin for Sepsis-associated Hypotension

NCT01271114 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2014-03-10

No results posted yet for this 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)

Conditions

  • Septic Shock
  • Sepsis-associated Hypotension

Interventions

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

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

Sponsors & Collaborators

  • University of Castilla-La Mancha

    collaborator OTHER

  • Hospital General de Ciudad Real

    lead OTHER

Principal Investigators

  • Javier Pascual Ramírez · HGCR

  • Luis COLLAR VIÑUELAS, MD · HGCR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01271114 on ClinicalTrials.gov