Novel Biomarkers and Postoperative Kidney Injury in Radical Nephrectomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking University First Hospital
About this trial
The incidence of acute kidney injury (AKI) after radical nephrectomy exceeds 40%. Currently, the KDIGO criteria are the recognized diagnostic standard for AKI. These criteria primarily use serum creatinine and urine output as key indicators, but both parameters have certain limitations, such as delayed response, insensitivity, and inaccuracy. This study aims to simultaneously monitor perioperative novel renal damaging, stressful, and functional biomarkers in patients undergoing radical nephrectomy, and to investigate their predictive value for AKI and postoperative 1-year chronic kidney disease (CKD).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years;
Scheduled to undergo unilateral radical nephrectomy.
Disqualifiers
Solitary kidney;
Preoperative diagnosis of chronic kidney disease stages G4 or G5 (GFR <30 mL/min/1.73m²);
Tumor invasion of the vena cava requiring thrombectomy;
Other conditions deemed by the investigator as unsuitable for participation in this study.
Trial population
Targeting patients undergoing radical nephrectomy for renal cell carcinoma
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 2 trial groupsGroup A: AKI group/CKD group
Group B: non-AKI group/non-CKD group
Trial outcomes
Primary outcomes
1
The urinary [TIMP-2]×[IGFBP-7], urinary NGAL, urinary KIM-1, serum cystatin C and their combinations to predict postoperative AKI occurring within 7 days.
Novel biomarkers above were collected at the end of surgery, and at postoperative 1h, 6h, and 20h. AKI diagnosed according to 2012 KDIGO criteria (occurring within 7 days after surgery).
Time frame
Up to 7 days after surgery.Secondary outcomes
1
The urinary [TIMP-2]×[IGFBP-7], urinary NGAL, urinary KIM-1, serum cystatin C and their combinations to predict new onset/worsening CKD occurring within 1 year after surgery.
Novel biomarkers above were collected before and at the end of surgery, and at postoperative 1h, 6h, and 20h. CKD diagnosed according to 2024 KDIGO-CKD criteria (occurring within 1 year after surgery).
Time frame
Up to 1 year after surgery2
The urinary [TIMP-2]×[IGFBP-7], urinary NGAL, urinary KIM-1, serum cystatin C combined with clinically important risk factors to predict postoperative AKI occurring within 7 days after surgery.
Novel biomarkers above were collected before and at the end of surgery, and at postoperative 1h, 6h, and 20h. AKI diagnosed according to 2012 KDIGO criteria (occurring within 7 days after surgery).
Time frame
Up to 7 days after surgery.3
The postoperative urinary [TIMP-2]×[IGFBP-7], urinary NGAL, urinary KIM-1, serum cystatin C combined with clinically important risk factors to predict postoperative the new onset/worsening CKD occurring within 1 year after surgery.
Novel biomarkers above were collected before and at the end of surgery, and at postoperative 1h, 6h, and 20h. CKD diagnosed according to 2024 KDIGO-CKD criteria (occurring within 1 year after surgery).
Time frame
Up to 1 year after surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov