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

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

Condition or disease Intervention/treatment Phase
Severe Sepsis Microcirculation Drug: Dopamine Drug: dobutamine Drug: enoximone Drug: nitroglycerine Drug: noradrenaline Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2007
Estimated Primary Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Primary Outcome Measures :
  1. Difference in SOFA (Sequential Organ Failure Assessment) score during the first 72 hours of treatment for severe sepsis [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. Severity, decrease and duration of organ failure over the complete ICU stay [ Time Frame: complete icu stay ]
  2. Duration of organ support [ Time Frame: during ICU treatment ]
  3. ICU and hospital length of stay [ Time Frame: hospital stay ]
  4. ICU and hospital mortality [ Time Frame: hospital stay ]
  5. Inflammatory response measured by IL-6/IL-10 [ Time Frame: 72 hours ]
  6. Plasma concentration of asymmetric dimethyl arginine (ADMA [ Time Frame: 72 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00484133

Contact: Rutger v Raalte, MD 0031205993007
Contact: Peter vd Voort, MD 0031205993007

Onze Lieve Vrouwe Gasthuis, intensive care Recruiting
Amsterdam, Netherlands, 1090 HM
Contact: Rutger v Raalte, MD    0031205993007   
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: R. van Raalte, Onze Lieve Vrouwe gasthuis Identifier: NCT00484133     History of Changes
Other Study ID Numbers: WO-06.068
First Posted: June 8, 2007    Key Record Dates
Last Update Posted: January 22, 2008
Last Verified: January 2008

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

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Adrenergic alpha-Agonists
Vasoconstrictor Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors