TPA-AKI: Transcriptional and Proteomic Analysis of Acute Kidney Injury

Sponsor

University Hospital Muenster (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06064305

Collaborator

(none)

Enrollment

14.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	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 Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Transcriptional and Proteomic Analysis of Acute Kidney Injury

Anticipated Study Start Date :

Sep 29, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Septic AKI patients 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 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.

Arm

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

non-AKI patients undergoing routine nephrectomy

Other: No study-specific interventions

Outcome Measures

Primary Outcome Measures

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

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.
RRT incidence [28 days]
incidence of renal replacement therapy
ICU length of stay [Through study completion, an average of 1 year.]
Length of stay for ICU
Hospital length of stay [Through study completion, an average of 1 year.]
Hospital length of stay
Mortality [28 day]
28 day mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 150 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital Muenster

Investigators

Study Chair: Alexander Zarbock, MD, University Hospital Muenster

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital Muenster

ClinicalTrials.gov Identifier:

NCT06064305

Other Study ID Numbers:

AnIt22-03

First Posted:

Oct 3, 2023

Last Update Posted:

Oct 3, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Acute Kidney Injury

Wounds and Injuries

Study Results

No Results Posted as of Oct 3, 2023