Transcriptional and Proteomic Analysis of Acute Kidney Injury

Not yet recruiting

• Conditions: Acute Kidney Injury
• Interventions: Other: No study-specific interventions

• Registration Number: NCT06064305
• Lead Sponsor: University Hospital Muenster

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.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-01
• Study First Submitted QC: 2023-09-28
• Last Update Submitted: 2023-09-28
• Study Start: 2023-09-29
• Study First Posted: 2023-10-03
• Last Update Posted: 2023-10-03
• Primary Completion: 2024-10-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Septic AKI patients	No study-specific interventions	Septic AKI patients
Non-septic post-cardiothoracic AKI patients	No study-specific interventions	Non-septic post-cardiothoracic surgery AKI patients
non-AKI patients undergoing routine nephrectomy	No study-specific interventions	non-AKI patients undergoing routine nephrectomy

Primary Outcome Measures

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

Secondary Outcome Measures

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