Transcriptional and Proteomic Analysis of Acute Kidney Injury (TPA-AKI)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Other: No study-specific interventions

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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Alexander Zarbock, MD; Phone Number: 47252 +4925183; Email: zarbock@uni-muenster.de
• Study Contact Backup: Name: Andreas Margraf, MD; Email: andreas.margraf@ukmuenster.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

AKI patients, nephrectomy patients

Description

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Septic AKI patients	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.
Non-septic post-cardiothoracic AKI patients; Non-septic post-cardiothoracic surgery AKI patients	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.
non-AKI patients undergoing routine nephrectomy	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.

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

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Investigators: Study Chair: Alexander Zarbock, MD, University hospital Muenster

Study record dates

Study Major Dates

• Study Start (Estimated): September 29, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 1, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 3, 2023

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: AnIt22-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No