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Acute kidney injury

An acute kidney injury, object technology, applied in the direction of instrumentation, diagnostic recording/measurement, diagnosis, etc., can solve the problems that are not widely available

Inactive Publication Date: 2015-08-26
NOVARTIS AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Various clinical algorithms have been proposed for predicting severe AKI based on preoperative risk factors, resulting in Renal Replacement Theory (RRT), but objective tests for early diagnosis of lower-grade renal impairment are not widely available

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0157] Example 1: Summary of Clinical Data

[0158] Data for this analysis were collected in patients undergoing cardiopulmonary bypass surgery in an observational, prospective, exploratory study. Patients under the age of 18 or of either sex who underwent elective surgery and gave written informed consent were eligible for inclusion in the trial. Among patients enrolled in the trial, patients had to meet the following criteria to be evaluated in this analysis:

[0159] - Patient completes the study

[0160] - Obtain a baseline / screening serum creatinine value and at least two serum creatinine measurement levels over a 24 to 72 hour time window. Since serum creatinine is typically obtained only every 24 hours, we consider this criterion met for practical purposes if it is in the 12- to 84-hour time window.

[0161] - Patient has at least two urine samples collected at 1, 2, 4 or 8 hour time points

[0162] - Patient has at least one urine sample collected at 12, 24 or 48 h...

Embodiment 2

[0174] Example 2: Biomarkers and pretreatments in the study

[0175] For each biomarker, certain preprocessing steps were performed before it was used in the analysis. Due to the sensitivity of the assay used, it may occur that the marker in urine is below the limit of determination and thus no value is reported or the value is below the limit of quantification (in which case a value may be reported). In both cases, we replaced the measured value with a value equal to half the limit of quantitation for that biomarker and sample batch. The resulting measurements are referred to below as preprocessed measurements.

[0176] In the following analyses, we used this pretreatment measure along with a urine creatinine (UCREA) normalized measure. For this normalization, preprocessed measurements of urine creatinine from the same urine sample were used. This normalization was performed by dividing the pre-processed biomarker measurement of the urine by the pre-processed urine creatin...

Embodiment 3

[0179] Example 3: Univariate Evaluation Model

[0180] For each biomarker in the study, we calculated the area under the receiver operating curve (AUC) for the two binary endpoints. In the first assessment, we compared patients classified as "injury phase" or "failure phase" with patients classified as "no AKI" or "risk phase". In the second assessment, we excluded patients classified as "injury phase" or "failure phase" and compared only patients classified as "risk phase" with patients classified as "no AKI".

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Abstract

The present invention relates to a method of predicting the severity of acute kidney injury following cardiac surgery.

Description

technical field [0001] The present invention relates to a method of predicting and treating acute kidney injury. Background technique [0002] Acute kidney injury (AKI) is a common and serious complication of cardiopulmonary bypass (CPB). AKI is new or worsening renal insufficiency characterized by a relatively acute decrease in glomerular filtration rate (GFR), often accompanied by a decrease in urine output (Mehta et al., 2007, J Vasc Surg. 46(5):1085 ; author reply 1085). AKI most commonly occurs after episodes of transient hypotension from any cause, but can also occur in response to nephrotoxins or radiocontrast agents. The clinical picture of AKI can be found in 5%-7% of all hospitalized patients and can be more common in complex surgical settings. By definition, AKI occurs in as many as 3%-40% of adults following cardiopulmonary bypass (CPB). Among those patients who experienced AKI as a complication of cardiac surgery, the odds of death increased from 4-fold in r...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68
CPCG01N2333/54G01N2800/60G01N33/6893G01N2800/347G16H50/30A61B5/7275G01N33/70G01N2333/4703G01N2333/475G01N2333/775G01N2333/8139G01N2800/24
Inventor F·迪特尔勒H·赫夫林
Owner NOVARTIS AG
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