- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07497958
Ischemic Preconditioning Reduces the Severity of Acute Kidney Injury After Partial Nephrectomy
March 23, 2026 updated by: ZHOU FANGJIAN, Sun Yat-sen University
Ischemic Preconditioning Reduces the Severity of Acute Kidney Injury After Partial Nephrectomy: a Randomized Controlled Clinical Study
It is demonstrated that remote ischemic preconditioning can alleviate the degree of acute renal injury on the operated side in patients undergoing partial nephrectomy.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
The study cohort was randomly divided into two groups.
One group received remote ischemic preconditioning one day before partial nephrectomy, while the other group underwent partial nephrectomy directly.
The degree of acute renal injury on the operated side was compared between the two groups
Study Type
Interventional
Enrollment (Estimated)
174
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fangjian Zhou, professor
- Phone Number: 020-87343865
- Email: zhoufj@sysucc.org.cn
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510000
- 651 Dongfeng Road East, Yuexiu District, Guangzhou, P.R. China Sun Yat-sen University Cancer Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients who are scheduled to undergo partial nephrectomy, with no specific surgical procedure limitation, including laparoscopic surgery, robot-assisted surgery, and open surgery
- Aged 18 to 80
Possess good organ function status: sufficient organ function (based on the normal values of the clinical trial center)
- Blood routine test: WBC≥3.5×10^9/L, absolute neutrophil count ≥1.5×10^9/L, PLT≥75.0×10^9/L, HGB≥80g/L;
- Liver function: Total bilirubin ≤1.5×upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN;
Exclusion Criteria:
- The anesthesiologist assesses that the patient cannot tolerate general anesthesia surgery
- Individuals with severe cardiovascular and cerebrovascular diseases, uncontrolled hypertension, and diabetes
- Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m²
- Horseshoe kidney
- Solitary kidney
- Pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental : Ischemic preconditioning
One day before the surgery, use a sphygmomanometer to apply pressure to the patient's upper limb to 200mmHg for 5 minutes, then reduce the pressure to 0mmHg for 5 minutes, repeating this process for a total of 3 cycles.
On the second day, perform a routine partial nephrectomy
|
One day before the surgery, use a sphygmomanometer to apply pressure to the patient's upper limb to 200mmHg for 5 minutes, then reduce the pressure to 0mmHg for 5 minutes, repeating this process for a total of 3 cycles.
On the second day, perform a routine partial nephrectomy
|
|
Active Comparator: Comparator : No ischemic preconditioning
Routine partial nephrectomy
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Routine partial nephrectomy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
AIRD spectrum score based on the patient's preoperative creatinine level and postoperative peak creatinine level
Time Frame: 2 weeks after partial nephrectomy
|
The AIRD spectrum score was defined as: (observed peak SCr - SCr ideal-peak)/(SCr worstcase-peak - SCr ideal-peak) The range of this indicator should be between 0 and 1, with 0 and 1 representing two extreme situations.
0 indicates that the kidney on the operated side is completely undamaged, while 1 indicates that the kidney on the operated side has completely lost its function.
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2 weeks after partial nephrectomy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recovery from ischemia based on the changes in creatinine levels before and after the partial nephrectomy and volume retention rate after the partial nephrectomy
Time Frame: 3 month after surgery
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Recovery from ischemia = (%GFR saved)/(%parenchymal mass preserved)
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3 month after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fangjian Zhou, professor, Sun Yat-sen University Cancer Center (SYSUCC)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Study Registration Dates
First Submitted
March 15, 2026
First Submitted That Met QC Criteria
March 23, 2026
First Posted (Actual)
March 27, 2026
Study Record Updates
Last Update Posted (Actual)
March 27, 2026
Last Update Submitted That Met QC Criteria
March 23, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Renal Insufficiency
- Urologic Neoplasms
- Carcinoma
- Kidney Neoplasms
- Acute Kidney Injury
- Carcinoma, Renal Cell
- Investigative Techniques
- Therapeutics
- Ischemic Preconditioning
Other Study ID Numbers
- B2026-114
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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