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Microcirculatory Changes During Magnesium Sulphate Infusion in Sepsis

This study has been completed.
Sponsor:
Collaborator:
Lithuanian University of Health Sciences
Information provided by:
Medical Centre Leeuwarden
ClinicalTrials.gov Identifier:
NCT01332734
First received: April 4, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  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:

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

Further study details as provided by Medical Centre Leeuwarden:

Primary Outcome Measures:
  • microvascular flow index [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 4, 2011
Last Updated: April 4, 2011
Health Authority: Lithuania: Bioethics Committee

Keywords provided by Medical Centre Leeuwarden:
microcirculation
SDF
magnesium sulfate

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

ClinicalTrials.gov processed this record on June 18, 2013