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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00025079
Enrollment
15
Registered
2021-04-28
Start date
2020-12-08
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A41 R57.2

Interventions

Group 1: The aim of the study is to determine the significance of the ESR method with regard to the transport properties of albumin and to compare it with the ABIC method developed at the University M

Sponsors

MedInnovation GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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 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 Translated with www.DeepL.com/Translator (free version)

Exclusion criteria

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;

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Germany

Contacts

Public ContactKatharina Schölkopf

Unimedizin Rostock

katharina.schoelkopf@med.uni-rostock.de0381 494 2620

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026