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

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ClinicalTrials.gov Identifier: NCT02426645
Recruitment Status : Active, not recruiting
First Posted : April 27, 2015
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Marc-H. Dahlke, Ph. D., University Hospital Regensburg

Brief Summary:

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.


Condition or disease
Sepsis Multiple Organ Failure

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Microcirculatory Alteration and Biomarkers: New Approach for Early Assessment of Septic Multi-organ Dysfunction
Study Start Date : April 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis




Primary Outcome Measures :
  1. Assessment of early post-operative course of novel cellular injury biomarkers as well as microvascular perfusion in critically ill patients with severe sepsis and to collection any first evidence of the association of these markers with the SOFA-Score [ Time Frame: 60 weeks ]

Secondary Outcome Measures :
  1. 28 day mortality [ Time Frame: 60 weeks ]
  2. 90 day mortality [ Time Frame: 60 weeks ]
  3. Length of ICU stay [ Time Frame: 60 weeks ]
  4. Length of hospital stay [ Time Frame: 60 weeks ]
  5. Early post-operative course of microvascular perfusion of the kidney and muscle vasculature bed using CEUS [ Time Frame: 60 weeks ]
  6. Incidence of acute kidney injury (AKI) within the first 48 hours as based on current Kidney Disease: Improving Global Outcomes (KDIGO) recommendation [ Time Frame: 60 weeks ]
  7. Incidence of acute kidney injury (AKI) within the first 7 days as based on current Kidney Disease: Improving Global Outcomes (KDIGO) recommendation [ Time Frame: 60 weeks ]
  8. Need for renal replacement therapy (RRT) after admission to ICU [ Time Frame: 60 weeks ]
  9. Identification of an "immunological fingerprint" indicating multi-organ dysfunction [ Time Frame: 60 weeks ]
    Flow cytometry


Biospecimen Retention:   Samples With DNA
Blood Urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with severe sepsis of abdominal origin within 24h after onset and performed source control
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426645


Locations
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Germany
Department of Surgery, University Hospital Regensburg
Regensburg, Bavaria, Germany, 93053
Sponsors and Collaborators
Prof. Dr. Marc-H. Dahlke, Ph. D.
Investigators
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Principal Investigator: Marc H Dahlke, Prof. Dr. University Hospital Regensburg

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Responsible Party: Prof. Dr. Marc-H. Dahlke, Ph. D., Professor, University Hospital Regensburg
ClinicalTrials.gov Identifier: NCT02426645     History of Changes
Other Study ID Numbers: Mibisep
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018

Keywords provided by Prof. Dr. Marc-H. Dahlke, Ph. D., University Hospital Regensburg:
Biomarkers
Sepsis
Multi organ dysfunction
Immunomonitoring
CEUS

Additional relevant MeSH terms:
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Sepsis
Multiple Organ Failure
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock