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
Information provided by:
Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier:
First received: June 6, 2007
Last updated: January 17, 2008
Last verified: January 2008
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

Condition Intervention Phase
Severe Sepsis
Drug: Dopamine
Drug: dobutamine
Drug: enoximone
Drug: nitroglycerine
Drug: noradrenaline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Onze Lieve Vrouwe Gasthuis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: June 2007
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00484133

Contact: Rutger v Raalte, MD 0031205993007 R.vanRaalte@olvg.nl
Contact: Peter vd Voort, MD 0031205993007 P.H.J.vanderVoort@olvg.nl

Onze Lieve Vrouwe Gasthuis, intensive care Recruiting
Amsterdam, Netherlands, 1090 HM
Contact: Rutger v Raalte, MD    0031205993007    R.vanRaalte@olvg.nl   
Principal Investigator: Rutger v Raalte, MD         
Sponsors and Collaborators
Onze Lieve Vrouwe Gasthuis
Principal Investigator: Rutger v Raalte, MD Onze Lieve Vrouwe Gasthuis, intensive care unit
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: R. van Raalte, Onze Lieve Vrouwe gasthuis
ClinicalTrials.gov Identifier: NCT00484133     History of Changes
Other Study ID Numbers: WO-06.068 
Study First Received: June 6, 2007
Last Updated: January 17, 2008
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Onze Lieve Vrouwe Gasthuis:
severe sepsis
Orthogonal polarisation spectral

Additional relevant MeSH terms:
Pathologic Processes
Systemic Inflammatory Response Syndrome
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on May 02, 2016