Microcirculation Guided Therapy Versus "Standard Treatment" of Severe Sepsis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Onze Lieve Vrouwe Gasthuis.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier:
NCT00484133
First received: June 6, 2007
Last updated: January 17, 2008
Last verified: January 2008

June 6, 2007
January 17, 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 ] [ Designated as safety issue: Yes ]
Difference in SOFA (Sequential Organ Failure Assessment) score during the first 72 hours of treatment for severe sepsis [ Time Frame: 72 hours ]
Complete list of historical versions of study NCT00484133 on ClinicalTrials.gov Archive Site
  • Severity, decrease and duration of organ failure over the complete ICU stay [ Time Frame: complete icu stay ] [ Designated as safety issue: No ]
  • Duration of organ support [ Time Frame: during ICU treatment ] [ Designated as safety issue: No ]
  • ICU and hospital length of stay [ Time Frame: hospital stay ] [ Designated as safety issue: No ]
  • ICU and hospital mortality [ Time Frame: hospital stay ] [ Designated as safety issue: No ]
  • Inflammatory response measured by IL-6/IL-10 [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Plasma concentration of asymmetric dimethyl arginine (ADMA [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • 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 ]
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Severe Sepsis
  • Microcirculation
  • Drug: Dopamine
  • Drug: dobutamine
  • Drug: enoximone
  • Drug: nitroglycerine
  • Drug: noradrenaline
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
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
Both
18 Years and older
No
Contact: Rutger v Raalte, MD 0031205993007 R.vanRaalte@olvg.nl
Contact: Peter vd Voort, MD 0031205993007 P.H.J.vanderVoort@olvg.nl
Netherlands
 
NCT00484133
WO-06.068
No
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