SepsisNCT02426645
Microcirculatory Alteration and Biomarkers: New Approach for Early Assessment of Septic Multi-organ Dysfunction
An observational study of Sepsis and Multiple Organ Failure, run by Prof. Dr. Marc-H. Dahlke, Ph. D. at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Multiple Organ Failure
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2015to Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with severe sepsis of abdominal origin within 24h after onset and performed source control
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Surgery, University Hospital Regensburg
Regensburg, Bavaria, 93053
About this study
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
- Medical subject headings
- Sepsis, Multiple Organ Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60 weeks
Secondary outcomes (9)
28 day mortality
Measured: 60 weeks
90 day mortality
Measured: 60 weeks
Length of ICU stay
Measured: 60 weeks
Length of hospital stay
Measured: 60 weeks
Early post-operative course of microvascular perfusion of the kidney and muscle vasculature bed using CEUS
Measured: 60 weeks
Incidence of acute kidney injury (AKI) within the first 48 hours as based on current Kidney Disease: Improving Global Outcomes (KDIGO) recommendation
Measured: 60 weeks
Incidence of acute kidney injury (AKI) within the first 7 days as based on current Kidney Disease: Improving Global Outcomes (KDIGO) recommendation
Measured: 60 weeks
Need for renal replacement therapy (RRT) after admission to ICU
Measured: 60 weeks
Identification of an "immunological fingerprint" indicating multi-organ dysfunction
Flow cytometry
Measured: 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Marc-H. Dahlke, Ph. D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Marc-H. Dahlke, Ph. D., University Hospital Regensburg
- Investigators
- Marc H Dahlke, Prof. Dr., Principal investigator, University Hospital Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426645
- Sponsor's protocol ID
- Mibisep
- Status last verified
- May 2018
- First submitted
- 16 Apr 2015
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcirculatory Alteration and Biomarkers: New Approach for Early Assessment of Septic Multi-organ Dysfunction
- ClinicalTrials.gov ID
- NCT02426645
- Acronym / sponsor ID
- Mibisep
- Conditions
- Sepsis, Multiple Organ Failure
- Keywords
- Biomarkers, Sepsis, Multi organ dysfunction, Immunomonitoring, CEUS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Prof. Dr. Marc-H. Dahlke, Ph. D.University, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 27 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with severe sepsis of abdominal origin within 24h after onset and performed source control
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Pre-existing renal-replacement therapy in the pre-operative course
- Pre-existing shock
- Acute coronary syndrome
- Active hemorrhage
- Trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
9 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc H Dahlke, Prof. Dr. principal investigator
University Hospital Regensburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Multiple Organ Failure, run by Prof. Dr. Marc-H. Dahlke, Ph. D. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018.