Microcirculation Guided Therapy Versus "Standard Treatment" of Severe Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Nitroglycerine on Microcirculatory Abnormalities During Sepsis

NCT00493415

Sepsis Septic Shock

COMPLETED PHASE3

Preemptive Resuscitation for Eradication of Septic Shock

NCT01449721

Sepsis Severe Sepsis

COMPLETED NA

Hemodynamic and Perfusion Response to Drotrecogin Alfa (Activated) in Patients With Septic Shock

NCT00279214

Sepsis Septic Shock

COMPLETED PHASE4

Safety and Efficacy of Procalcitonin Guided Antibiotic Therapy in Adult Intensive Care Units (ICU's)

NCT01139489

Sepsis Severe Sepsis Septic Shock

COMPLETED NA

The Study of Drotrecogin Alfa (Activated) in Adult Patients With Severe Sepsis at a Low Risk of Death

NCT00568737

Sepsis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Severe Sepsis Microcirculation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dopamine

Intervention Type DRUG

dobutamine

Intervention Type DRUG

enoximone

Intervention Type DRUG

nitroglycerine

Intervention Type DRUG

noradrenaline

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No