Transcriptional and Proteomic Analysis of Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
Acute kidney injury is associated with worsened outcome for critically ill patients. Sepsis-associated and non-septic cardiothoracic surgery associated AKI have been reported, nonetheless, precise pathomechanistic differences as well as detectability of transcriptional and proteomic changes in correlation with imaging and plasma markers are unclear.

Detailed Description
-----------------
Acute kidney injury is a common and detrimental finding in critically ill/sepsis patients as well as non-septic patients post cardiothoracic surgery. In many cases renal replacement therapy is required and an acute kidney injury is linked to increased morbidity and mortality in intensive care patients. Using routinely obtained clinical samples as well as imaging data, this observational trial investigates the transcriptomic and proteomic determinants detectable in septic and non-septic AKI patient subsets and their correlation with outcome and AKI diagnostic parameters.

Official Title
-----------------
Transcriptional and Proteomic Analysis of Acute Kidney Injury

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Other: No study-specific interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: study consent; KDIGO>=2; vasoplegia and/or sepsis or elective nephrectomy. Exclusion criteria: Age<18 years; pregnancy/nursing; preexisting CKD with eGFR<60m/min; dialysis; former ogran transplantation; HIV; hematologic malignancies; immunsuppression; 4h post biopsy non-pausable effective anticoagulation; pre-existing coagulopathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 150 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Septic AKI patients<br>Septic AKI patients | Other: No study-specific interventions<br>* Septic AKI patients, post-cardiothoracic AKI patients and non-AKI patients undergoing routine nephrectomy. Due to the observational design of the study, no study-specific interventions are performed. The treatment of the patients is completely guided by the responsible ICU physicians and the respective specialists.<br>|
| Non-septic post-cardiothoracic AKI patients<br>Non-septic post-cardiothoracic surgery AKI patients | Other: No study-specific interventions<br>* Septic AKI patients, post-cardiothoracic AKI patients and non-AKI patients undergoing routine nephrectomy. Due to the observational design of the study, no study-specific interventions are performed. The treatment of the patients is completely guided by the responsible ICU physicians and the respective specialists.<br>|
| non-AKI patients undergoing routine nephrectomy<br>non-AKI patients undergoing routine nephrectomy | Other: No study-specific interventions<br>* Septic AKI patients, post-cardiothoracic AKI patients and non-AKI patients undergoing routine nephrectomy. Due to the observational design of the study, no study-specific interventions are performed. The treatment of the patients is completely guided by the responsible ICU physicians and the respective specialists.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of transcriptional and proteomic gene regulation in tissue with clinical molecular Imaging and AKI biomarkers. | Proteomic and RNAseq-based multi-omics pattern recognition. | Through study completion, an average of 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Further organ failure based on systemic assessment | Occurrence of organ failure based on hospital data including routinely applied scores, laboratory values or clinical examination. | Through study completion, an average of 1 year. | 
| RRT incidence | incidence of renal replacement therapy | 28 days | 
| ICU length of stay | Length of stay for ICU | Through study completion, an average of 1 year. | 
| Hospital length of stay | Hospital length of stay | Through study completion, an average of 1 year. | 
| Mortality | 28 day mortality | 28 day |