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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02426645
• Other study ID #: Mibisep
• Status: Active, not recruiting
• Start date: April 2015
• Est. completion date: April 2019

Study information

• Verified date: May 2018
• Source: University Hospital Regensburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: April 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Organ Failure
• Sepsis

Locations

Country	Name	City	State
Germany	Department of Surgery, University Hospital Regensburg	Regensburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Marc-H. Dahlke, Ph. D.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28 day mortality		60 weeks
Secondary	90 day mortality		60 weeks
Secondary	Length of ICU stay		60 weeks
Secondary	Length of hospital stay		60 weeks
Secondary	Early post-operative course of microvascular perfusion of the kidney and muscle vasculature bed using CEUS		60 weeks
Secondary	Incidence of acute kidney injury (AKI) within the first 48 hours as based on current Kidney Disease: Improving Global Outcomes (KDIGO) recommendation		60 weeks
Secondary	Incidence of acute kidney injury (AKI) within the first 7 days as based on current Kidney Disease: Improving Global Outcomes (KDIGO) recommendation		60 weeks
Secondary	Need for renal replacement therapy (RRT) after admission to ICU		60 weeks
Secondary	Identification of an "immunological fingerprint" indicating multi-organ dysfunction	Flow cytometry	60 weeks