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Status unknownNCT00484133Updated Jan 22, 2008

Microcirculation Guided Therapy Versus "Standard Treatment" of Severe Sepsis

A Phase 4 interventional study of Dopamine and dobutamine in Severe Sepsis and Microcirculation, sponsored by Onze Lieve Vrouwe Gasthuis. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-01-22.

Sponsored by Onze Lieve Vrouwe Gasthuis · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Severe Sepsis
  • Microcirculation

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Keywords

  • sepsis
  • severe sepsis
  • microcirculation
  • Orthogonal polarisation spectral
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In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's planned enrollment of 80 is below the median of 105 across 896 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Onze Lieve Vrouwe Gasthuis is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Interventions

  • DrugDopamine
  • Drugdobutamine
  • Drugenoximone
  • Drugnitroglycerine
  • Drugnoradrenaline
06

What researchers measure

Primary outcomes

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

    Time frame: 72 hours

Secondary outcomes

  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

07

Study locations

1 of 1 sites recruiting
  • Onze Lieve Vrouwe Gasthuis, intensive care
    Amsterdam, 1090 HM, Netherlands
    • Rutger v Raalte, MD · Contact · R.vanRaalte@olvg.nl · 0031205993007
    • Rutger v Raalte, MD · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 25032942 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00484133
Lead sponsor
Onze Lieve Vrouwe Gasthuis
First posted
Jun 8, 2007
Start date
Jun 2007
Primary completion
Dec 2008 (estimated)
Last update
Jan 22, 2008

Study contacts

Rutger v Raalte, MD
Contact
R.vanRaalte@olvg.nl
0031205993007
Peter vd Voort, MD
Contact
P.H.J.vanderVoort@olvg.nl
0031205993007
Rutger v Raalte, MD
principal investigator · Onze Lieve Vrouwe Gasthuis, intensive care unit

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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