Microcirculatory Changes During Magnesium Sulphate Infusion in Sepsis

April 4, 2011 updated by: Medical Centre Leeuwarden

Microcirculatory Changes During Open Label Magnesium Sulphate Infusion in Severe Sepsis and Septic Shock

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
      • Kaunas, Lithuania, LT 44307
        • Hospital of Lithuanian University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

severe sepsis and septic shock after adequate fluid resuscitation according to pulmonary artery catheter measurements

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Centre Leeuwarden

Collaborators

Lithuanian University of Health Sciences

Investigators

  • Principal Investigator: A Pranskunas, MD, Lithuanian university of sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

April 4, 2011

First Submitted That Met QC Criteria

April 4, 2011

First Posted (Estimate)

April 11, 2011

Study Record Updates

Last Update Posted (Estimate)

April 11, 2011

Last Update Submitted That Met QC Criteria

April 4, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-03.03 nr BE-2-6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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