Microcirculation Guided Therapy Versus "Standard Treatment" of Severe Sepsis - Full Text View

Sponsored by:	Onze Lieve Vrouwe Gasthuis
Information provided by:	Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier:	NCT00484133

Purpose

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 Microcirculation	Drug: Dopamine Drug: dobutamine Drug: enoximone Drug: nitroglycerine Drug: noradrenaline	Phase IV

MedlinePlus related topics: Sepsis

Drug Information available for: Dobutamine Dobutamine hydrochloride Dobutamine lactobionate Dobutamine tartrate Dopamine Dopamine hydrochloride Nitroglycerin Norepinephrine Norepinephrine bitartrate Enoximone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

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.

Eligibility

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

Criteria

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

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

Contacts

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

Locations

Netherlands
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

Investigators

Principal Investigator:

Rutger v Raalte, MD

Onze Lieve Vrouwe Gasthuis, intensive care unit

More Information

Responsible Party:	Onze Lieve Vrouwe gasthuis ( R. van Raalte )
Study ID Numbers:	WO-06.068
Study First Received:	June 6, 2007
Last Updated:	January 17, 2008
ClinicalTrials.gov Identifier:	NCT00484133
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Onze Lieve Vrouwe Gasthuis:

sepsis
severe sepsis
microcirculation
Orthogonal polarisation spectral

Study placed in the following topic categories:

Nitroglycerin
Systemic Inflammatory Response Syndrome
Sepsis
Dopamine

Enoximone
Norepinephrine
Dobutamine
Inflammation

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Adrenergic Agents
Cardiotonic Agents
Sympathomimetics
Physiological Effects of Drugs
Enzyme Inhibitors
Cardiovascular Agents

Infection
Protective Agents
Pharmacologic Actions
Adrenergic Agonists
Phosphodiesterase Inhibitors
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009