Microcirculation Guided Therapy Versus "Standard Treatment" of Severe Sepsis

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

Study Overview

• Status: Unknown
• Conditions: Severe Sepsis; Microcirculation
• Intervention / Treatment: Drug: Dopamine; Drug: dobutamine; Drug: enoximone; Drug: nitroglycerine; Drug: noradrenaline

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
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Rutger v Raalte, MD; Phone Number: 0031205993007; Email: R.vanRaalte@olvg.nl
• Study Contact Backup: Name: Peter vd Voort, MD; Phone Number: 0031205993007; Email: P.H.J.vanderVoort@olvg.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1090 HM
    • Recruiting
    • Onze Lieve Vrouwe Gasthuis, intensive care
    • Contact: Rutger v Raalte, MD; Phone Number: 0031205993007; Email: R.vanRaalte@olvg.nl
    • Principal Investigator: Rutger v Raalte, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Plasma concentration of asymmetric dimethyl arginine (ADMA	72 hours

Collaborators and Investigators

• Sponsor: Onze Lieve Vrouwe Gasthuis
• Investigators: Principal Investigator: Rutger v Raalte, MD, Onze Lieve Vrouwe Gasthuis, intensive care unit

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (ANTICIPATED): December 1, 2008

Study Registration Dates

• First Submitted: June 6, 2007
• First Submitted That Met QC Criteria: June 6, 2007
• First Posted (ESTIMATE): June 8, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): January 22, 2008
• Last Update Submitted That Met QC Criteria: January 17, 2008
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Keywords: microcirculation; sepsis; severe sepsis; Orthogonal polarisation spectral
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Dopamine Agents; Phosphodiesterase Inhibitors; Adrenergic beta-Agonists; Sympathomimetics; Adrenergic beta-1 Receptor Agonists; Vasoconstrictor Agents; Phosphodiesterase 3 Inhibitors; Norepinephrine; Nitroglycerin; Dopamine; Dobutamine; Enoximone
• Other Study ID Numbers: WO-06.068