Microcirculation Guided Therapy Versus "Standard Treatment" of Severe Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00484133
Recruitment Status : Unknown
Verified January 2008 by Onze Lieve Vrouwe Gasthuis.
Recruitment status was:  Recruiting
First Posted : June 8, 2007
Last Update Posted : January 22, 2008
Information provided by:
Onze Lieve Vrouwe Gasthuis

June 6, 2007
June 8, 2007
January 22, 2008
June 2007
December 2008   (Final data collection date for primary outcome measure)
Difference in SOFA (Sequential Organ Failure Assessment) score during the first 72 hours of treatment for severe sepsis [ Time Frame: 72 hours ]
Same as current
Complete list of historical versions of study NCT00484133 on Archive Site
  • Severity, decrease and duration of organ failure over the complete ICU stay [ Time Frame: complete icu stay ]
  • Duration of organ support [ Time Frame: during ICU treatment ]
  • ICU and hospital length of stay [ Time Frame: hospital stay ]
  • ICU and hospital mortality [ Time Frame: hospital stay ]
  • Inflammatory response measured by IL-6/IL-10 [ Time Frame: 72 hours ]
  • Plasma concentration of asymmetric dimethyl arginine (ADMA [ Time Frame: 72 hours ]
Same as current
Not Provided
Not Provided
Microcirculation Guided Therapy Versus "Standard Treatment" of Severe Sepsis
Not Provided
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
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.
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Severe Sepsis
  • Microcirculation
  • Drug: Dopamine
  • Drug: dobutamine
  • Drug: enoximone
  • Drug: nitroglycerine
  • Drug: noradrenaline
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
Not Provided
December 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
R. van Raalte, Onze Lieve Vrouwe gasthuis
Onze Lieve Vrouwe Gasthuis
Not Provided
Principal Investigator: Rutger v Raalte, MD Onze Lieve Vrouwe Gasthuis, intensive care unit
Onze Lieve Vrouwe Gasthuis
January 2008

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