Microcirculatory Alteration and Biomarkers: New Approach for Early Assessment of Septic Multi-organ Dysfunction

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

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Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2019-04-30

Brief Summary

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The aim of this study is to investigate associations between early structural cellular injury and microvascular alteration with progression of septic organ dysfunction according to total SOFA-Score (an ICU-scoring system - the Sequential Organ Failure Assessment Score). Patients will be monitored for renal (TIMP-2, IGFBP7), and intestinal biomarkers (plasma i-FABP) in conjunction with kidney and muscle vascular bed microvascular perfusion analysis assessed by contrast-enhanced ultrasonography (CEUS). In parallel, a comprehensive analysis of patients' immunological status will be conducted using an established, on-site immune monitoring panel.

The ultimate goal of this study is an early identification of septic patients developing multiorgan dysfunction which may facilitate a timely novel intervention in the future to improve outcome.

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Detailed Description

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Conditions

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Sepsis Multiple Organ Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Patients ≥18 years of age with severe sepsis and fulfill the following criteria at the admission to ICU:

* Peritonitis (abdominal infection) and performed source control (either surgically or interventionally)
* 2 or more criteria for systemic inflammatory response syndrome (temperature \>38° or\<36°; heart rate \>90 beats per minute; respiratory rate \>20 breaths per minute or paCO2 \<32 mmHg; white blood cell count \>12,000/mm3, \<4000mm3 or \>10% immature forms) and serum lactate level of 4mmol/l and more or refractory hypotension - mean arterial pressure \<65mmHg or systolic blood pressure \<90mmHg after fluid challenge of 1000ml or more /30min
* Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Written informed consent prior to any study procedures

Exclusion Criteria

* Pre-existing renal-replacement therapy in the pre-operative course
* Pre-existing shock
* Acute coronary syndrome
* Active hemorrhage
* Trauma
* Known allergy to ultrasound contrast media
* Anemia with hemoglobin concentration \< 7g/dl
* Patients not able to give written informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No