Transcriptional and Proteomic Analysis of Acute Kidney Injury

Acute Kidney Injury Clinical Trial

— TPA-AKI  

Official title:

Transcriptional and Proteomic Analysis of Acute Kidney Injury

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06064305
• Other study ID #: AnIt22-03
• Status: Not yet recruiting
• Start date: September 29, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: September 2023
• Source: University Hospital Muenster
• Contact: Alexander Zarbock, MD
• Phone: +4925183
• Email: zarbock[@]uni-muenster.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: October 1, 2024
• Gender: All
• Age group: 18 Years to 150 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Other:
• No study-specific interventions
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	RRT incidence	incidence of renal replacement therapy	28 days
Secondary	ICU length of stay	Length of stay for ICU	Through study completion, an average of 1 year.
Secondary	Hospital length of stay	Hospital length of stay	Through study completion, an average of 1 year.
Secondary	Mortality	28 day mortality	28 day