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NCT01332734 Clinical Trial

Microcirculatory Changes During Magnesium Sulphate Infusion in Sepsis

Septic Shock Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01332734
Other study ID # 2010-03.03 nr BE-2-6
Secondary ID
Status Completed
Phase N/A
First received April 4, 2011
Last updated April 4, 2011
Start date March 2010
Est. completion date January 2011

Study information
Verified date April 2011
Source Medical Centre Leeuwarden
Contact n/a
Is FDA regulated No
Health authority Lithuania: Bioethics Committee
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date January 2011
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Magnesium Sulfate
2 gram in 1 hour

Locations
Country Name City State
Lithuania Hospital of Lithuanian university of health sciences Kaunas

Sponsors (2)
Lead Sponsor Collaborator
Medical Centre Leeuwarden Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

Outcome
Type Measure Description Time frame Safety issue
Primary microvascular flow index 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 No
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