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

Sponsor

Prof. Dr. Marc-H. Dahlke, Ph. D. (Other)

Overall Status

Unknown status

CT.gov ID

NCT02426645

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Sepsis Multiple Organ Failure

Study Design

Study Type:

Observational

Anticipated 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 :

Apr 1, 2015

Anticipated Primary Completion Date :

Jan 1, 2019

Anticipated Study Completion Date :

Apr 1, 2019

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
Incidence of acute kidney injury (AKI) within the first 48 hours as based on current Kidney Disease: Improving Global Outcomes (KDIGO) recommendation [60 weeks]
Incidence of acute kidney injury (AKI) within the first 7 days as based on current Kidney Disease: Improving Global Outcomes (KDIGO) recommendation [60 weeks]
Need for renal replacement therapy (RRT) after admission to ICU [60 weeks]
Identification of an "immunological fingerprint" indicating multi-organ dysfunction [60 weeks]
Flow cytometry

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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