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Microcirculatory Changes During Magnesium Sulphate Infusion in Sepsis

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ClinicalTrials.gov Identifier: NCT01332734
Recruitment Status : Completed
First Posted : April 11, 2011
Last Update Posted : April 11, 2011
Sponsor:
Collaborator:
Lithuanian University of Health Sciences
Information provided by:
Medical Centre Leeuwarden

Brief Summary:
During infections (sepsis) bloodflow in small vessels (microcirculation) becomes disturbed. Restoration of bloodpressure and cardiac performance may not be sufficient to correct these alterations. Magnesium is a potent vasodilator which may be used to open up the small vessels, in order to reduce organ failure.

Condition or disease Intervention/treatment
Severe Sepsis Septic Shock Drug: Magnesium Sulfate

Detailed Description:
In a single-center open label study we evaluated the effects of magnesium sulphate (MgS) infusion on the sublingual microcirculation perfusion in fluid resuscitated patients with severe sepsis and septic shock within the first 48 hours after ICU admission. Directly prior to and after 1 hour of magnesium sulphate (MgS) infusion (2 gram) systemic hemodynamic variables, sublingual SDF images and standard laboratory tests, were obtained.

Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Microcirculatory Changes During Open Label Magnesium Sulphate Infusion in Severe Sepsis and Septic Shock
Study Start Date : March 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock
U.S. FDA Resources

Group/Cohort Intervention/treatment
severe sepsis and septic shock Drug: Magnesium Sulfate
2 gram in 1 hour



Primary Outcome Measures :
  1. microvascular flow index [ Time Frame: 1 hour ]
    Directly prior to and after 1 hour of magnesium sulphate (MgS) infusion (2 gram) systemic hemodynamic variables, sublingual SDF images and standard laboratory tests, were obtained.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
severe sepsis and septic shock after adequate fluid resuscitation according to pulmonary artery catheter measurements
Criteria

Inclusion Criteria:

  • severe sepsis and septic shock

Exclusion Criteria:

  • pregnancy
  • oral bleeding
  • age < 18 years
  • liver cirrhosis
  • acute arrhythmias
  • advanced malignancy or a mean arterial pressure (MAP) < 65 mmHg refractory to vasopressors

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): NCT01332734


Locations
Lithuania
Hospital of Lithuanian university of health sciences
Kaunas, Lithuania, LT 44307
Sponsors and Collaborators
Medical Centre Leeuwarden
Lithuanian University of Health Sciences
Investigators
Principal Investigator: A Pranskunas, MD Lithuanian university of sciences

Responsible Party: Andrius Pranskunas, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT01332734     History of Changes
Other Study ID Numbers: 2010-03.03 nr BE-2-6
First Posted: April 11, 2011    Key Record Dates
Last Update Posted: April 11, 2011
Last Verified: April 2011

Keywords provided by Medical Centre Leeuwarden:
microcirculation
SDF
magnesium sulfate

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents