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Microcirculation Guided Therapy Versus "Standard Treatment" of Severe Sepsis

Primary Purpose

Severe Sepsis, Microcirculation

Status
Unknown status
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Dopamine
dobutamine
enoximone
nitroglycerine
noradrenaline
Sponsored by
Onze Lieve Vrouwe Gasthuis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Sepsis focused on measuring sepsis, severe sepsis, microcirculation, Orthogonal polarisation spectral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 18 years or older
  • admission to the intensive care unit with severe sepsis, defined in according with a modification of the American College of Chest Physician/SCCM guidelines criteria
  • intention to provide full intensive care treatment for at least 72 hours and
  • written informed consent to be obtained from patient or next of kin.

Exclusion Criteria:

  • haematologic malignancy
  • metastatic malignancy
  • AIDS with CD4 < 50 cells/mm3
  • liver cirrhosis Child Pugh B & C
  • pregnancy
  • post resuscitation with GCS < 8 of 15 and treatment with induced hypothermia

Sites / Locations

  • Onze Lieve Vrouwe Gasthuis, intensive careRecruiting

Outcomes

Primary Outcome Measures

Difference in SOFA (Sequential Organ Failure Assessment) score during the first 72 hours of treatment for severe sepsis

Secondary Outcome Measures

Severity, decrease and duration of organ failure over the complete ICU stay
Duration of organ support
ICU and hospital length of stay
ICU and hospital mortality
Inflammatory response measured by IL-6/IL-10
Plasma concentration of asymmetric dimethyl arginine (ADMA

Full Information

First Posted
June 6, 2007
Last Updated
January 17, 2008
Sponsor
Onze Lieve Vrouwe Gasthuis
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1. Study Identification

Unique Protocol Identification Number
NCT00484133
Brief Title
Microcirculation Guided Therapy Versus "Standard Treatment" of Severe Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Onze Lieve Vrouwe Gasthuis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to asses the recovery of organ failure between two resuscitation protocols in severe sepsis: standard, pressure guided therapy versus a microcirculation guided therapy
Detailed Description
Despite continued improvements in medical therapy, mortality from septic shock has remained between 30% and 70% for the past three decades with only a slight decrease in mortality rate. Standard treatment of septic shock is fluid resuscitation, followed by agents with vasopressor activity to correct hypotension in septic shock. The question rises whether vasopressors should be the first line of action in septic shock Opening and recruiting the microcirculation are expected to improve regional organ function and tissue distress in severe sepsis. Beside fluid resuscitation, vasodilatation, in this respect, enhances microcirculatory flow while vasoconstriction causes a reduction in microcirculatory flow. On the other hand, a minimal perfusion pressure should be present. Our aim is to asses the effects of two resuscitation protocols in severe sepsis: the "standard treatment" using predefined pressure goals versus a microcirculation guided therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis, Microcirculation
Keywords
sepsis, severe sepsis, microcirculation, Orthogonal polarisation spectral

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Dopamine
Intervention Type
Drug
Intervention Name(s)
dobutamine
Intervention Type
Drug
Intervention Name(s)
enoximone
Intervention Type
Drug
Intervention Name(s)
nitroglycerine
Intervention Type
Drug
Intervention Name(s)
noradrenaline
Primary Outcome Measure Information:
Title
Difference in SOFA (Sequential Organ Failure Assessment) score during the first 72 hours of treatment for severe sepsis
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Severity, decrease and duration of organ failure over the complete ICU stay
Time Frame
complete icu stay
Title
Duration of organ support
Time Frame
during ICU treatment
Title
ICU and hospital length of stay
Time Frame
hospital stay
Title
ICU and hospital mortality
Time Frame
hospital stay
Title
Inflammatory response measured by IL-6/IL-10
Time Frame
72 hours
Title
Plasma concentration of asymmetric dimethyl arginine (ADMA
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18 years or older admission to the intensive care unit with severe sepsis, defined in according with a modification of the American College of Chest Physician/SCCM guidelines criteria intention to provide full intensive care treatment for at least 72 hours and written informed consent to be obtained from patient or next of kin. Exclusion Criteria: haematologic malignancy metastatic malignancy AIDS with CD4 < 50 cells/mm3 liver cirrhosis Child Pugh B & C pregnancy post resuscitation with GCS < 8 of 15 and treatment with induced hypothermia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rutger v Raalte, MD
Phone
0031205993007
Email
R.vanRaalte@olvg.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Peter vd Voort, MD
Phone
0031205993007
Email
P.H.J.vanderVoort@olvg.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rutger v Raalte, MD
Organizational Affiliation
Onze Lieve Vrouwe Gasthuis, intensive care unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Onze Lieve Vrouwe Gasthuis, intensive care
City
Amsterdam
ZIP/Postal Code
1090 HM
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rutger v Raalte, MD
Phone
0031205993007
Email
R.vanRaalte@olvg.nl
First Name & Middle Initial & Last Name & Degree
Rutger v Raalte, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
25032942
Citation
van der Voort PH, van Zanten M, Bosman RJ, van Stijn I, Wester JP, van Raalte R, Oudemans-van Straaten HM, Zandstra DF. Testing a conceptual model on early opening of the microcirculation in severe sepsis and septic shock: a randomised controlled pilot study. Eur J Anaesthesiol. 2015 Mar;32(3):189-98. doi: 10.1097/EJA.0000000000000126.
Results Reference
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Microcirculation Guided Therapy Versus "Standard Treatment" of Severe Sepsis

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