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Microcirculatory Changes During Magnesium Sulphate Infusion in Sepsis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01332734
First Posted: April 11, 2011
Last Update Posted: April 11, 2011
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:
Lithuanian University of Health Sciences
Information provided by:
Medical Centre Leeuwarden
  Purpose
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 Intervention
Severe Sepsis Septic Shock Drug: Magnesium Sulfate

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Microcirculatory Changes During Open Label Magnesium Sulphate Infusion in Severe Sepsis and Septic Shock

Resource links provided by NLM:


Further study details as provided by Medical Centre Leeuwarden:

Primary Outcome Measures:
  • 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.


Enrollment: 14
Study Start Date: March 2010
Study Completion Date: January 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
severe sepsis and septic shock Drug: Magnesium Sulfate
2 gram in 1 hour

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.
  Eligibility

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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
  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): 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
  More Information

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 Submitted: April 4, 2011
First Posted: April 11, 2011
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