Dopamine and dobutamine and enoximone in Severe Sepsis and Microcirculation - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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 Time Frame: 72 hours	72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Severity, decrease and duration of organ failure over the complete ICU stay Time Frame: complete icu stay	complete icu stay
Duration of organ support Time Frame: during ICU treatment	during ICU treatment
ICU and hospital length of stay Time Frame: hospital stay	hospital stay
ICU and hospital mortality Time Frame: hospital stay	hospital stay
Inflammatory response measured by IL-6/IL-10 Time Frame: 72 hours	72 hours
Plasma concentration of asymmetric dimethyl arginine (ADMA Time Frame: 72 hours	72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Onze Lieve Vrouwe Gasthuis

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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