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

Tracking Information

First Received Date ^ICMJE

April 4, 2011

Last Updated Date

April 4, 2011

Start Date ^ICMJE

March 2010

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Microcirculatory Changes During Magnesium Sulphate Infusion in Sepsis

Official Title ^ICMJE

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

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.

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 ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Severe Sepsis
Septic Shock

Intervention ^ICMJE

Drug: Magnesium Sulfate

2 gram in 1 hour

Study Group/Cohort (s)

severe sepsis and septic shock

Intervention: Drug: Magnesium Sulfate

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2011

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Lithuania

Administrative Information

NCT Number ^ICMJE

NCT01332734

Other Study ID Numbers ^ICMJE

2010-03.03 nr BE-2-6

Has Data Monitoring Committee

Responsible Party

Andrius Pranskunas, Lithuanian University of Health Sciences

Study Sponsor ^ICMJE

Medical Centre Leeuwarden

Collaborators ^ICMJE

Lithuanian University of Health Sciences

Investigators ^ICMJE

Principal Investigator:

A Pranskunas, MD

Lithuanian university of sciences

Information Provided By

Medical Centre Leeuwarden

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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