Microcirculation Guided Therapy Versus "Standard Treatment" of Severe Sepsis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Onze Lieve Vrouwe Gasthuis.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier:
NCT00484133
First received: June 6, 2007
Last updated: January 17, 2008
Last verified: January 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Dobutamine
Dopamine
Enoximone
Norepinephrine
Nitroglycerin
Dopamine Agents
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vasodilator Agents
Adrenergic alpha-Agonists
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on August 18, 2014