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Pro-adm as a therapy monitoring marker for critcally ill patients

A patient-severity technology, applied in the field of therapy monitoring, that solves problems such as accurate measurement of disease severity that has not yet been revealed, improving medical care and avoiding costs

Active Publication Date: 2020-04-24
BRAHMS GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, an accurate measure of disease severity has not been shown

Method used

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  • Pro-adm as a therapy monitoring marker for critcally ill patients
  • Pro-adm as a therapy monitoring marker for critcally ill patients
  • Pro-adm as a therapy monitoring marker for critcally ill patients

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0433] Example 1: Patient Characteristics

[0434] Table 1 summarizes patient characteristics at study enrollment.

[0435] A total of 1089 patients with severe sepsis (13.0%) or septic shock (87.0%) were analyzed, of which 445 (41.3%) and 633 (58.7%) patients also met sepsis-3 and septic shock-3, respectively standard. The mean age of the registered patients was 65.7 (13.7) years old, and the mean SOFA score was 10.0 (3.3) points. The 28-day all-cause mortality rate (N=1076) was 26.9% (sepsis-3: 20.0%; septic shock-3: 32.1%), and the in-hospital mortality rate was 33.4% (sepsis-3: 24.4%; Toxic shock-3: 40.4%). 836 patients (77.7%) were found to have infections originating from a single lesion, among them, pulmonary (N=324; 30.1%), intra-abdominal (N=252; 23.4%), genitourinary (N=57; 5.3%) and bone / soft tissue (N=50; 4.6%) origin were most prevalent. The corresponding mortality rates were 26.5%, 24.6%, 22.8% and 28.0%, respectively. Multiple sources of infection were fou...

example 2

[0436] Example 2: Relationship of Baseline Biomarkers and Clinical Scores to Mortality

[0437] Univariate and multivariate Cox regression analyzes found that MR-proADM was most strongly associated with 28-day mortality in the overall patient population and in the sepsis-3 and septic shock-3 subgroups (Table 2). The corresponding AUROC analysis found significant differences in all biomarkers and clinical scores compared with MR-proADM, except APACHE II (subgroup of patients with sepsis-3).

[0438] Similar results were found for 7-day, 90-day, ICU, and in-hospital mortality prediction (Table 3), with the addition of MR-proADM to all potential biomarker and clinical score combinations (N=63) significantly improving the prognostic power (Table 4).

example 3

[0439] Example 3: Identification of high-risk patients

[0440] The total patient population was further stratified according to existing SOFA severity levels, as well as biomarker and clinical score performance in predicting 28-day mortality assessed in each subgroup. MR-proADM showed the highest accuracy for all parameters in the low (SOFA ≤ 7) and moderate (8 ≤ SOFA ≤ 13) severity SOFA subgroups (Table 5; Table 6).

[0441] Two corresponding MR-proADM cutoffs were then calculated to identify low (≤2.7 nmol / l) and high (>10.9 nmol / l) severity subgroups at baseline. Compared with SOFA, it can be found in low (MR-proADM / SOFA: N=265 / 232; 9.8% / 13.8% mortality) and high (MR-proADM / SOFA: N=161 / 155; 55.9% / 41.3%) A more precise reclassification was performed under the severity cutoff (Table 7).

[0442] The subgroup of 94 patients (9.3%) with high MR-proADM concentrations and corresponding low or intermediate SOFA values ​​had mortality rates of 57.4% and 68.9% at 28 and 90 days, ...

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Abstract

The invention relates to a method for therapy monitoring, comprising the prognosis, risk assessment and / or risk stratification of a subsequent adverse event in the health of a patient, comprising providing a sample of said patient, wherein the patient has been diagnosed as being critically ill and medical treatment has been initiated, wherein the sample is isolated from the patient after diagnosisand treatment initiation; determining a level of proadrenomedullin (proADM) or fragment(s) thereof in said sample, wherein said level of proADM or fragment(s) thereof correlates with the likelihood of a subsequent adverse event in the health of said patient. In a preferred embodiment the invention relates to a method comprising additionally determining a level of procalcitonin (PCT) or fragment(s) thereof in a sample isolated from the patient. Preferably, a method of the present invention comprises determining a level of procalcitonin (PCT) or fragment(s) thereof in a first sample isolated from the patient, wherein said first sample is isolated at or before the time point of diagnosis and treatment initiation (time point 0); determining a level of PCT or fragment(s) thereof in a second sample isolated from said patient after diagnosis and treatment initiation; and determining whether a difference in the level of PCT or fragment(s) thereof in the second sample is evident in comparisonto the level of PCT or fragment(s) thereof in the first sample.

Description

[0001] The present invention relates to a method for therapeutic monitoring including prognosis, risk assessment and / or risk stratification of subsequent adverse events with respect to the health of a patient, said method comprising providing a sample of said patient, wherein the patient has been diagnosed as critically ill and has initiated medical treatment, wherein the sample is isolated from the patient after diagnosis and treatment has begun; determining the level of proadrenomedullin (proADM) or a fragment thereof in said sample, wherein said proADM Levels of or fragments thereof correlate with the likelihood of subsequent adverse events in the patient's health. In a preferred embodiment, the present invention relates to a method further comprising determining the level of procalcitonin (PCT) or a fragment thereof in a sample isolated from a patient. Preferably, the method of the invention comprises determining the level of procalcitonin (PCT) or a fragment thereof in a fi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N33/74
CPCG01N33/6893G01N33/74G01N2800/22G01N2800/52G01N2800/56G01N2333/575G01N2800/26A61K49/0004
Inventor D·威尔逊
Owner BRAHMS GMBH
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