Microcirculatory Changes During Magnesium Sulphate Infusi... | NCT01332734

Studies
Microcirculatory Changes During Magnesium Sulphate Infusion in Sepsis

NCT01332734

Sponsor

Frisius Medisch Centrum

Status

Completed

Last Update Posted

Apr 11, 2011Estimated

Enrollment

14Actual

Phase

Not provided

Conditions

Severe Sepsis
Septic Shock

Interventions

Magnesium Sulfate

Countries

Lithuania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Aug 2010Actual

Completion Date

Jan 2011Actual

First Submitted Date

Apr 4, 2011

First Submission Date that Met QC Criteria

Apr 4, 2011

First Posted Date

Apr 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2011

Last Update Posted Date

Apr 11, 2011Estimated

Name	Class
Lithuanian University of Health Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
severe sepsis and septic shock			Drug: Magnesium Sulfate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnesium Sulfate	Drug	2 gram in 1 hour	severe sepsis and septic shock

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
A Pranskunas, MD	Lithuanian university of sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital of Lithuanian university of health sciences		Kaunas		LT 44307	Lithuania

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis
D012772	Shock, Septic

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008278	Magnesium Sulfate

Ancestor Terms

ID	Term
D017616	Magnesium Compounds
D007287	Inorganic Chemicals
D013431	Sulfates
D013464	Sulfuric Acids

Browse Leaves

Not provided

Browse Branches

Not provided