Microcirculation Guided Therapy Versus "Standard Treatment" of Severe Sepsis

NCT00484133 | Unknown Phase 4

• 1 other identifier: WO-06.068
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Severe Sepsis; Microcirculation

Keywords

sepsis; severe sepsis; microcirculation; Orthogonal polarisation spectral

Outcome Measures

Primary Outcomes (1)

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

  72 hours

Secondary Outcomes (6)

• Severity, decrease and duration of organ failure over the complete ICU stay

  complete icu stay

• Duration of organ support

  during ICU treatment

• ICU and hospital length of stay

  hospital stay

• ICU and hospital mortality

  hospital stay

• Inflammatory response measured by IL-6/IL-10

  72 hours

Interventions

Dopamine DRUG

dobutamine DRUG

enoximone DRUG

nitroglycerine DRUG

noradrenaline DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Onze Lieve Vrouwe Gasthuis: lead

Study Sites (1)

Onze Lieve Vrouwe Gasthuis, intensive care

Amsterdam, 1090 HM, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 25032942 DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

Dopamine; Dobutamine; Enoximone; Nitroglycerin; Norepinephrine

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenethylamines; Ethylamines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nitro Compounds; Ethanolamines; Amino Alcohols; Alcohols

Study Officials

• Rutger v Raalte, MD

  Onze Lieve Vrouwe Gasthuis, intensive care unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rutger v Raalte, MD

CONTACT

0031205993007; R.vanRaalte@olvg.nl

Peter vd Voort, MD

CONTACT

0031205993007; P.H.J.vanderVoort@olvg.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 6, 2007
• First Posted: June 8, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2008
• Last Updated: January 22, 2008

Record last verified: 2008-01

Locations

NL (1)