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

NCT02426645 | Unknown

• 1 other identifier: Mibisep
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Multiple Organ Failure

Keywords

Biomarkers; Sepsis; Multi organ dysfunction; Immunomonitoring; CEUS

Outcome Measures

Primary Outcomes (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

  60 weeks

Secondary Outcomes (9)

• 28 day mortality

  60 weeks

• 90 day mortality

  60 weeks

• Length of ICU stay

  60 weeks

• Length of hospital stay

  60 weeks

• Early post-operative course of microvascular perfusion of the kidney and muscle vasculature bed using CEUS

  60 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with severe sepsis of abdominal origin within 24h after onset and performed source control

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dr. Marc-H. Dahlke, Ph. D.: lead

Study Sites (1)

Department of Surgery, University Hospital Regensburg

Regensburg, Bavaria, 93053, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood Urine

MeSH Terms

Conditions

Sepsis; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Marc H Dahlke, Prof. Dr.

  University Hospital Regensburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: April 27, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: April 1, 2019
• Last Updated: May 7, 2018

Record last verified: 2018-05

Locations

DE (1)