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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

Tracking Information
First Submitted Date April 16, 2015
First Posted Date April 27, 2015
Last Update Posted Date May 7, 2018
Study Start Date April 2015
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 21, 2015)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02426645 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 21, 2015)
  • 28 day mortality [ Time Frame: 60 weeks ]
  • 90 day mortality [ Time Frame: 60 weeks ]
  • Length of ICU stay [ Time Frame: 60 weeks ]
  • Length of hospital stay [ Time Frame: 60 weeks ]
  • Early post-operative course of microvascular perfusion of the kidney and muscle vasculature bed using CEUS [ Time Frame: 60 weeks ]
  • 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 ]
  • 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 ]
  • Need for renal replacement therapy (RRT) after admission to ICU [ Time Frame: 60 weeks ]
  • Identification of an "immunological fingerprint" indicating multi-organ dysfunction [ Time Frame: 60 weeks ]
    Flow cytometry
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Microcirculatory Alteration and Biomarkers: New Approach for Early Assessment of Septic Multi-organ Dysfunction
Official Title Microcirculatory Alteration and Biomarkers: New Approach for Early Assessment of Septic Multi-organ Dysfunction
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood Urine
Sampling Method Non-Probability Sample
Study Population Adult patients with severe sepsis of abdominal origin within 24h after onset and performed source control
Condition
  • Sepsis
  • Multiple Organ Failure
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: April 21, 2015)
25
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02426645
Other Study ID Numbers Mibisep
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Prof. Dr. Marc-H. Dahlke, Ph. D., University Hospital Regensburg
Study Sponsor Prof. Dr. Marc-H. Dahlke, Ph. D.
Collaborators Not Provided
Investigators
Principal Investigator: Marc H Dahlke, Prof. Dr. University Hospital Regensburg
PRS Account University Hospital Regensburg
Verification Date May 2018