Pilot study on the use of albumin function test by ESR method in ICU patients for the detection of sepsis/septic shock and its follow-up.

• Conditions: R57.2; A41; Other sepsis; Septic shock

• Registration Number: DRKS00025079
• Lead Sponsor: MedInnovation GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-28
• Study Completion: 2022-01-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Sepsis Group
- At least 18 years
- Patients diagnosed with sepsis as defined by Sepsis-3 (life-threatening organ dysfunction caused by a dysregulated immune response to infection.
Clinical Criteria: SOFA score =2, screening tool: qSOFA at least 2 of 3 (AF=22/min; RR syst. =100mmHg; impaired mental status: GCS<15).

Septic shock
- At least 18 yrs.
- Septic shock = sepsis + cardiovascular collapse unresponsive to hydration and vasopressors necessary to maintain MAP > 65mmHg, lactate = 2 mmol/L

Control group
- At least 18 yrs.
- Patient -of the intensive care unit of the Internal Medicine of the University Medical Center Rostock without sepsis / septic shock.

- If sepsis / septic shock occurs within 7 days, the patient will be kept as control group 2, but an additional control patient without sepsis / septic shock will be included in the study

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Exclusion Criteria

Extracorporeal treatment with citrate anticoagulation ongoing at the time of blood collection;
Albumin substitution;
More than 500ml of FFP or red cell concentrate 12 hours prior to blood collection;
Patients with liver cirrhosis;

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
On the one hand, it will be investigated how the binding and detoxification efficiency differs between the three patient groups using the ESR method. On the other hand, the significance of both tests (ESR method and ABIC test) with regard to the characterization of albumin function will be compared.

Secondary Outcome Measures

Name	Time	Method
The following clinical parameters for characterizing sepsis will be determined and compared in the study:<br>CRP<br>Procalcitonin<br>Small blood count<br>Lactate<br>Norepinephrine (possibly other vasopressors)<br>Electrolytes (Na, K, Ca)<br>SOFA score (PaO2/FiO2, Glasgow Coma Score, MAP, vasopressors (dopamine, dobutamine, epinephrine), bilirubin, platelets, creatinine)