NephrectomyNCT05149196
Goal-directed Hemodynamic Management and Kidney Injury After Radical Nephrectomy or Nephroureterectomy
A study testing Targeted hemodynamic management and Routine care in people with Nephrectomy and Nephroureterectomy, run by Peking University First Hospital at 1 site in China.
Trial summary
Radical nephrectomy and nephroureterectomy are common operations for the treatment of renal cell carcinoma and upper tract urothelial carcinoma, respectively. However, acute kidney injury frequently occurs after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrectomy, Nephroureterectomy, Hemodynamic Management
- What is being tested?
- Targeted hemodynamic management and Routine care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,724 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2025to 30 Dec 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 years or older;
- Scheduled to undergo unilateral radical nephrectomy for renal cancer or unilateral radical nephroureterectomy for upper tract urothelial carcinoma.
Who cannot join
- Diagnosed with chronic kidney disease stage 4 or stage 5 (GFR<30 ml/min/1.73m2) before surgery;
- Uncontrolled severe hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg);
- Combined with cardiovascular diseases with Revised Cardiac Risk Index (RCRI) >1 or metabolic equivalents (METs) <4;
- Unable to communicate due to severe dementia, language barrier, or end-stage disease before surgery;
- Other conditions that are considered unsuitable for inclusion (specific reasons should be indicated).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing University First Hospital
Beijing, Beijing Municipality, 100034
Dong-Xin Wang, MD, PHD, 86 10 83572784, wangdongxin@hotmail.com
Qiong-Fang Wu, MD, +86 83575138, wuqf91@163.com
About this study
Official title: Impact of Goal-directed Hemodynamic Management on Occurrence of Acute and Persistent Kidney Injury After Radical Nephrectomy or Nephroureterectomy: A Randomized Controlled Trial
Radical nephrectomy and nephroureterectomy are common operations for the treatment of renal cell carcinoma and upper tract urothelial carcinoma, respectively. However, acute kidney injury frequently occurs after surgery. And the occurrence of acute kidney injury is associated with an increased risk of chronic kidney disease. Intraoperative hypotension is identified as an important risk factor of postoperative acute kidney injury. Preliminary studies showed that goal-directed hemodynamic management may reduce kidney injury after surgery but requires further demonstration. We hypothesized that goal-directed hemodynamic management combining hydration, inotropes, and forced diuresis to maintain pulse pressure variation <9%, mean arterial pressure ≥85 mmHg, and urine flow rate >200 ml/h (3 ml/kg/h) may reduce the incidence of acute kidney injury and improve long-term renal outcome after radical nephrectomy or nephroureterectomy. The purpose of this study is to investigate the effect of goal-directed hemodynamic management on the occurrence of acute and persistent kidney injury in patients following radical nephrectomy and nephroureterectomy.
Read the detailed description
Renal cancer accounts for 20.3% of urinary system tumors, and the incidence is still increasing. Surgical resection is the main treatment of renal cancer; radical nephrectomy is the standard operation for renal cancer of stage T2 or above. For upper tract urothelial carcinoma (UTUC) which includes renal pelvis cancer and ureteral cancer, radical nephroureterectomy is the gold standard treatment. Both procedures involve the removal of one kidney. Acute kidney injury (AKI) is a common complication after radical nephrectomy and nephroureterectomy, with reported incidence from 53.9% to 72.7%. AKI is associated with the development of chronic kidney disease (CKD) and is an independent risk factor of new onset CKD in patients without underlying kidney disease. A meta-analysis showed that, at one year after surgery, patients with AKI had a 2.7-fold increased risk of new onset or progression of CKD and a 4.8-fold increased risk of end-stage renal disease. Moreover, even mild AKI is associated with renal insufficiency at 1 to 2 years after surgery.
Taking active measures to reduce the incidence of AKI may improve long-term renal function after radical nephrectomy and nephroureterectomy. Many clinical studies show that intraoperative hypotension is an important risk factor of postoperative kidney injury. For example, a study found that intraoperative mean arterial pressure (MAP) <65 mmHg or a decrease of more than 20% from baseline was associated with an increased risk of postoperative AKI; the risk of AKI increased alone with prolonged duration of hypotension. However, recent randomized controlled trials showed inconsistent results regarding the effect of tight blood pressure management strategy on kidney outcome. Relevant studies indicated that hydration with forced diuresis and inotropes to maintain cardiac output and blood pressure might improve renal outcome.
In a previous pilot trial of the authors, goal-directed hemodynamic management combining hydration and inotropics reduced the incidence of AKI by about 40% in patients following partial nephrectomy. However, the difference was not statistically significant due to insufficient sample size. The purpose of this trial is to investigate whether goal-directed intraoperative hemodynamic management combining hydration, inotropics, and forced diuresis can reduce the occurrence of acute and persistent kidney injury in patients undergoing radical nephrectomy and nephroureterectomy.
- Conditions
- Nephrectomy, Nephroureterectomy, Hemodynamic Management, Acute Kidney Injury, Chronic Kidney Diseases
- Being tested
- Targeted hemodynamic management, Routine care
- Keywords
- Nephrectomy, Nephroureterectomy, Hemodynamic Management, Acute Kidney Injury, Chronic Kidney Diseases
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted hemodynamic managementOther
During anesthesia, hemodynamic managements include active hydration (>10 ml/kg/h), use of inotropes (dobutamine), and forced diuresis; the targets are to maintain pulse pressure variation <9%, mean arterial pressure ≥85 mmHg, and urine output >200 ml/h (3ml/kg/h).
During the first 48 hours after surgery, systolic blood pressure is maintained ≥110 mmHg or within 20% of baseline by delaying antihypertensive resumption, providing fluid challenge, and/or vasoactive infusion.
Routine careOther
During anesthesia, hemodynamic managements are conducted according to routine practice and usually include fluid infusion at a rate of 6-8 ml/kg/h without inotropics; the targets are to maintain mean arterial pressure ≥60 mmHg and urine output >0.5 ml/kg/h.
During the first 48 hours after surgery, hemodynamic management is performed according to routine practice.
| Study group | Role | What they receive |
|---|---|---|
| Targeted blood pressure management | Experimental | During anesthesia, hemodynamic managements include active hydration (>10 ml/kg/h), use of inotropes (dobutamine), and forced diuresis; the targets are to maintain pulse pressure variation <9%, mean arterial pressure ≥85 mmHg, and urine output >200 ml/h (3ml/kg/h).
During the first 48 hours after surgery, systolic blood pressure is maintained ≥110 mmHg or within 20% of baseline by delaying antihypertensive resumption, providing fluid challenge, and/or vasoactive infusion. Receives: Other: Targeted hemodynamic management |
| Routine care | Active comparator | During anesthesia, hemodynamic managements are conducted according to routine practice and usually include fluids infusion at a rate of 6-8 ml/kg/h without inotropics; the targets are to maintain mean arterial pressure ≥60 mmHg and urine output >0.5 ml/kg/h.
During the first 48 hours after surgery, hemodynamic management is performed according to routine practice. Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute kidney injury (early primary outcome)
Acute kidney injury is diagnosed and classified according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria. Acute kidney injury of stage 1 or above is defined as occurrence of acute kidney injury.
Measured: Up to 7 days after surgery
Time to new-onset or progression of chronic kidney disease (CKD) (long-term primary outcome).
New-onset CKD is defined as a decrease of glomerular filtration rate to <60 ml/min/1.73 m2 and persists for more than 3 months. Progression of CKD is defined as a decrease of glomerular filtration rate of 40% or more from baseline and persists for more than 3 months.
Measured: Up to 2 years after surgery
Secondary outcomes (6)
Incidence of myocardial injury after noncardiac surgery (MINS) within 7 days after surgery
MINS is diagnosed according to the Fourth Universal Definition of Myocardial Infarction (2018).
Measured: Up to 7 days after surgery
Incidence of delirium within 7 days after surgery
Delirium is assessed twice daily with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) or the 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM).
Measured: Up to 7 days after surgery
Incidence of surgical site infection within 30 days after surgery
Surgical site infection is diagnosed according to predefined definition.
Measured: Up to 30 days after surgery
Incidence of CKD within 3 months after surgery
Included new-onset or progression of CKD. New-onset CKD is defined as a decrease of glomerular filtration rate to <60 ml/min/1.73 m2 and persists for more than 3 months. Progression of CKD is defined as a decrease of glomerular filtration rate of 40% or more from baseline and persists for more than 3 months.
Measured: Up to 3 months after surgery
Proportion of various grades of CKD at different timepoints
CKD is diagnosed and classified according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
Measured: Up to 2 years after surgery
Event-free survival
Time interval from the end of surgery to new-onset or progression of CKD, serious events (required hospitalization or reoperation), or all-cause death, which ever come first. New-onset CKD is defined as a decrease of glomerular filtration rate to <60 ml/min/1.73 m2 and persists for more than 3 months. Progression of CKD is defined as a decrease of glomerular filtration rate of 40% or more from baseline and persists for more than 3 months.
Measured: Up to 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start10 Feb 2025
- Primary completion30 Dec 2032 (estimated)
- Study completion30 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for NephrectomyStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,724 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Dong-Xin Wang, MD, PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149196
- Sponsor's protocol ID
- 2021-417
- Status last verified
- Jun 2025
- First submitted
- 22 Nov 2021
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
PubMed 31912902Klatte T, Rossi SH, Stewart GD. Prognostic factors and prognostic models for renal cell carcinoma: a literature review. World J Urol. 2018 Dec;36(12):1943-1952. doi: 10.1007/s00345-018-2309-4. Epub 2018 Apr 30.
PubMed 29713755Cho A, Lee JE, Kwon GY, Huh W, Lee HM, Kim YG, Kim DJ, Oh HY, Choi HY. Post-operative acute kidney injury in patients with renal cell carcinoma is a potent risk factor for new-onset chronic kidney disease after radical nephrectomy. Nephrol Dial Transplant. 2011 Nov;26(11):3496-501. doi: 10.1093/ndt/gfr094. Epub 2011 Mar 15.
PubMed 21406544Garofalo C, Liberti ME, Russo D, Russo L, Fuiano G, Cianfrone P, Conte G, De Nicola L, Minutolo R, Borrelli S. Effect of post-nephrectomy acute kidney injury on renal outcome: a retrospective long-term study. World J Urol. 2018 Jan;36(1):59-63. doi: 10.1007/s00345-017-2104-7. Epub 2017 Oct 23.
PubMed 29063267Shin S, Han Y, Park H, Chung YS, Ahn H, Kim CS, Cho YP, Kwon TW. Risk factors for acute kidney injury after radical nephrectomy and inferior vena cava thrombectomy for renal cell carcinoma. J Vasc Surg. 2013 Oct;58(4):1021-7. doi: 10.1016/j.jvs.2013.02.247. Epub 2013 Apr 13.
PubMed 23591189Chawla LS, Eggers PW, Star RA, Kimmel PL. Acute kidney injury and chronic kidney disease as interconnected syndromes. N Engl J Med. 2014 Jul 3;371(1):58-66. doi: 10.1056/NEJMra1214243. No abstract available.
PubMed 24988558See EJ, Jayasinghe K, Glassford N, Bailey M, Johnson DW, Polkinghorne KR, Toussaint ND, Bellomo R. Long-term risk of adverse outcomes after acute kidney injury: a systematic review and meta-analysis of cohort studies using consensus definitions of exposure. Kidney Int. 2019 Jan;95(1):160-172. doi: 10.1016/j.kint.2018.08.036. Epub 2018 Nov 23.
PubMed 30473140Turan A, Cohen B, Adegboye J, Makarova N, Liu L, Mascha EJ, Qiu Y, Irefin S, Wakefield BJ, Ruetzler K, Sessler DI. Mild Acute Kidney Injury after Noncardiac Surgery Is Associated with Long-term Renal Dysfunction: A Retrospective Cohort Study. Anesthesiology. 2020 May;132(5):1053-1061. doi: 10.1097/ALN.0000000000003109.
PubMed 31929326Kim WH, Shin KW, Ji SH, Jang YE, Lee JH, Jeong CW, Kwak C, Lim YJ. Robust Association between Acute Kidney Injury after Radical Nephrectomy and Long-term Renal Function. J Clin Med. 2020 Feb 25;9(3):619. doi: 10.3390/jcm9030619.
PubMed 32106477Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
PubMed 23835589Sun LY, Wijeysundera DN, Tait GA, Beattie WS. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. Anesthesiology. 2015 Sep;123(3):515-23. doi: 10.1097/ALN.0000000000000765.
PubMed 26181335Monk TG, Bronsert MR, Henderson WG, Mangione MP, Sum-Ping ST, Bentt DR, Nguyen JD, Richman JS, Meguid RA, Hammermeister KE. Association between Intraoperative Hypotension and Hypertension and 30-day Postoperative Mortality in Noncardiac Surgery. Anesthesiology. 2015 Aug;123(2):307-19. doi: 10.1097/ALN.0000000000000756.
PubMed 26083768Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2017 Jan;126(1):47-65. doi: 10.1097/ALN.0000000000001432.
PubMed 27792044Wesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20.
PubMed 30236233Futier E, Lefrant JY, Guinot PG, Godet T, Lorne E, Cuvillon P, Bertran S, Leone M, Pastene B, Piriou V, Molliex S, Albanese J, Julia JM, Tavernier B, Imhoff E, Bazin JE, Constantin JM, Pereira B, Jaber S; INPRESS Study Group. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357. doi: 10.1001/jama.2017.14172.
PubMed 28973220
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Goal-directed Hemodynamic Management on Occurrence of Acute and Persistent Kidney Injury After Radical Nephrectomy or Nephroureterectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05149196
- Acronym / sponsor ID
- 2021-417
- Conditions
- Nephrectomy, Nephroureterectomy, Hemodynamic Management, Acute Kidney Injury, Chronic Kidney Diseases
- Keywords
- Nephrectomy, Nephroureterectomy, Hemodynamic Management, Acute Kidney Injury, Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,724 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 30 Dec 2032 (estimated)
- Study completion
- 30 Dec 2034 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Radical nephrectomy and nephroureterectomy are common operations for the treatment of renal cell carcinoma and upper tract urothelial carcinoma, respectively. However, acute kidney injury frequently occurs after surgery. And the occurrence of acute kidney injury is associated with an increased risk of chronic kidney disease. Intraoperative hypotension is identified as an important risk factor of postoperative acute kidney injury. Preliminary studies showed that goal-directed hemodynamic management may reduce kidney injury after surgery but requires further demonstration. We hypothesized that goal-directed hemodynamic management combining hydration, inotropes, and forced diuresis to maintain pulse pressure variation <9%, mean arterial pressure ≥85 mmHg, and urine flow rate >200 ml/h (3 ml/kg/h) may reduce the incidence of acute kidney injury and improve long-term renal outcome after radical nephrectomy or nephroureterectomy. The purpose of this study is to investigate the effect of goal-directed hemodynamic management on the occurrence of acute and persistent kidney injury in patients following radical nephrectomy and nephroureterectomy.
Detailed description
Renal cancer accounts for 20.3% of urinary system tumors, and the incidence is still increasing. Surgical resection is the main treatment of renal cancer; radical nephrectomy is the standard operation for renal cancer of stage T2 or above. For upper tract urothelial carcinoma (UTUC) which includes renal pelvis cancer and ureteral cancer, radical nephroureterectomy is the gold standard treatment. Both procedures involve the removal of one kidney. Acute kidney injury (AKI) is a common complication after radical nephrectomy and nephroureterectomy, with reported incidence from 53.9% to 72.7%. AKI is associated with the development of chronic kidney disease (CKD) and is an independent risk factor of new onset CKD in patients without underlying kidney disease. A meta-analysis showed that, at one year after surgery, patients with AKI had a 2.7-fold increased risk of new onset or progression of CKD and a 4.8-fold increased risk of end-stage renal disease. Moreover, even mild AKI is associated with renal insufficiency at 1 to 2 years after surgery.
Taking active measures to reduce the incidence of AKI may improve long-term renal function after radical nephrectomy and nephroureterectomy. Many clinical studies show that intraoperative hypotension is an important risk factor of postoperative kidney injury. For example, a study found that intraoperative mean arterial pressure (MAP) <65 mmHg or a decrease of more than 20% from baseline was associated with an increased risk of postoperative AKI; the risk of AKI increased alone with prolonged duration of hypotension. However, recent randomized controlled trials showed inconsistent results regarding the effect of tight blood pressure management strategy on kidney outcome. Relevant studies indicated that hydration with forced diuresis and inotropes to maintain cardiac output and blood pressure might improve renal outcome.
In a previous pilot trial of the authors, goal-directed hemodynamic management combining hydration and inotropics reduced the incidence of AKI by about 40% in patients following partial nephrectomy. However, the difference was not statistically significant due to insufficient sample size. The purpose of this trial is to investigate whether goal-directed intraoperative hemodynamic management combining hydration, inotropics, and forced diuresis can reduce the occurrence of acute and persistent kidney injury in patients undergoing radical nephrectomy and nephroureterectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted blood pressure management | Experimental | Other: Targeted hemodynamic managementDuring anesthesia, hemodynamic managements include active hydration (>10 ml/kg/h), use of inotropes (dobutamine), and forced diuresis; the targets are to maintain pulse pressure variation <9%, mean arterial pressure ≥85 mmHg, and urine output >200 ml/h (3ml/kg/h). During the first 48 hours after surgery, systolic blood pressure is maintained ≥110 mmHg or within 20% of baseline by delaying antihypertensive resumption, providing fluid challenge, and/or vasoactive infusion. |
| Routine care | Active comparator | Other: Routine careDuring anesthesia, hemodynamic managements are conducted according to routine practice and usually include fluids infusion at a rate of 6-8 ml/kg/h without inotropics; the targets are to maintain mean arterial pressure ≥60 mmHg and urine output >0.5 ml/kg/h. During the first 48 hours after surgery, hemodynamic management is performed according to routine practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age of 18 years or older;
- Scheduled to undergo unilateral radical nephrectomy for renal cancer or unilateral radical nephroureterectomy for upper tract urothelial carcinoma.
Key exclusion criteria (5 listed)
- Diagnosed with chronic kidney disease stage 4 or stage 5 (GFR<30 ml/min/1.73m2) before surgery;
- Uncontrolled severe hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg);
- Combined with cardiovascular diseases with Revised Cardiac Risk Index (RCRI) >1 or metabolic equivalents (METs) <4;
- Unable to communicate due to severe dementia, language barrier, or end-stage disease before surgery;
- Other conditions that are considered unsuitable for inclusion (specific reasons should be indicated).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted hemodynamic managementDuring anesthesia, hemodynamic managements include active hydration (>10 ml/kg/h), use of inotropes (dobutamine), and forced diuresis; the targets are to maintain pulse pressure variation <9%, mean arterial pressure ≥85 mmHg, and urine output >200 ml/h (3ml/kg/h). During the first 48 hours after surgery, systolic blood pressure is maintained ≥110 mmHg or within 20% of baseline by delaying antihypertensive resumption, providing fluid challenge, and/or vasoactive infusion. | Other | Targeted blood pressure management |
| Routine careDuring anesthesia, hemodynamic managements are conducted according to routine practice and usually include fluid infusion at a rate of 6-8 ml/kg/h without inotropics; the targets are to maintain mean arterial pressure ≥60 mmHg and urine output >0.5 ml/kg/h. During the first 48 hours after surgery, hemodynamic management is performed according to routine practice. | Other | Routine care |
Primary outcome
Incidence of acute kidney injury (early primary outcome)
Time frame: Up to 7 days after surgery
Acute kidney injury is diagnosed and classified according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria. Acute kidney injury of stage 1 or above is defined as occurrence of acute kidney injury.
Time to new-onset or progression of chronic kidney disease (CKD) (long-term primary outcome).
Time frame: Up to 2 years after surgery
New-onset CKD is defined as a decrease of glomerular filtration rate to <60 ml/min/1.73 m2 and persists for more than 3 months. Progression of CKD is defined as a decrease of glomerular filtration rate of 40% or more from baseline and persists for more than 3 months.
6 secondary outcomes
Incidence of myocardial injury after noncardiac surgery (MINS) within 7 days after surgery
Time frame: Up to 7 days after surgery
Incidence of delirium within 7 days after surgery
Time frame: Up to 7 days after surgery
Incidence of surgical site infection within 30 days after surgery
Time frame: Up to 30 days after surgery
Incidence of CKD within 3 months after surgery
Time frame: Up to 3 months after surgery
Proportion of various grades of CKD at different timepoints
Time frame: Up to 2 years after surgery
Event-free survival
Time frame: Up to 2 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Background: PubMed 31912902Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
- Background: PubMed 29713755Klatte T, Rossi SH, Stewart GD. Prognostic factors and prognostic models for renal cell carcinoma: a literature review. World J Urol. 2018 Dec;36(12):1943-1952. doi: 10.1007/s00345-018-2309-4. Epub 2018 Apr 30.
- Background: PubMed 21406544Cho A, Lee JE, Kwon GY, Huh W, Lee HM, Kim YG, Kim DJ, Oh HY, Choi HY. Post-operative acute kidney injury in patients with renal cell carcinoma is a potent risk factor for new-onset chronic kidney disease after radical nephrectomy. Nephrol Dial Transplant. 2011 Nov;26(11):3496-501. doi: 10.1093/ndt/gfr094. Epub 2011 Mar 15.
- Background: PubMed 29063267Garofalo C, Liberti ME, Russo D, Russo L, Fuiano G, Cianfrone P, Conte G, De Nicola L, Minutolo R, Borrelli S. Effect of post-nephrectomy acute kidney injury on renal outcome: a retrospective long-term study. World J Urol. 2018 Jan;36(1):59-63. doi: 10.1007/s00345-017-2104-7. Epub 2017 Oct 23.
- Background: PubMed 23591189Shin S, Han Y, Park H, Chung YS, Ahn H, Kim CS, Cho YP, Kwon TW. Risk factors for acute kidney injury after radical nephrectomy and inferior vena cava thrombectomy for renal cell carcinoma. J Vasc Surg. 2013 Oct;58(4):1021-7. doi: 10.1016/j.jvs.2013.02.247. Epub 2013 Apr 13.
- Background: PubMed 24988558Chawla LS, Eggers PW, Star RA, Kimmel PL. Acute kidney injury and chronic kidney disease as interconnected syndromes. N Engl J Med. 2014 Jul 3;371(1):58-66. doi: 10.1056/NEJMra1214243. No abstract available.
- Background: PubMed 30473140See EJ, Jayasinghe K, Glassford N, Bailey M, Johnson DW, Polkinghorne KR, Toussaint ND, Bellomo R. Long-term risk of adverse outcomes after acute kidney injury: a systematic review and meta-analysis of cohort studies using consensus definitions of exposure. Kidney Int. 2019 Jan;95(1):160-172. doi: 10.1016/j.kint.2018.08.036. Epub 2018 Nov 23.
- Background: PubMed 31929326Turan A, Cohen B, Adegboye J, Makarova N, Liu L, Mascha EJ, Qiu Y, Irefin S, Wakefield BJ, Ruetzler K, Sessler DI. Mild Acute Kidney Injury after Noncardiac Surgery Is Associated with Long-term Renal Dysfunction: A Retrospective Cohort Study. Anesthesiology. 2020 May;132(5):1053-1061. doi: 10.1097/ALN.0000000000003109.
- Background: PubMed 32106477Kim WH, Shin KW, Ji SH, Jang YE, Lee JH, Jeong CW, Kwak C, Lim YJ. Robust Association between Acute Kidney Injury after Radical Nephrectomy and Long-term Renal Function. J Clin Med. 2020 Feb 25;9(3):619. doi: 10.3390/jcm9030619.
- Background: PubMed 23835589Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
- Background: PubMed 26181335Sun LY, Wijeysundera DN, Tait GA, Beattie WS. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. Anesthesiology. 2015 Sep;123(3):515-23. doi: 10.1097/ALN.0000000000000765.
- Background: PubMed 26083768Monk TG, Bronsert MR, Henderson WG, Mangione MP, Sum-Ping ST, Bentt DR, Nguyen JD, Richman JS, Meguid RA, Hammermeister KE. Association between Intraoperative Hypotension and Hypertension and 30-day Postoperative Mortality in Noncardiac Surgery. Anesthesiology. 2015 Aug;123(2):307-19. doi: 10.1097/ALN.0000000000000756.
- Individual participant dataSharing planned: No
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Prostatectomy, Cystectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dong-Xin Wang, MD, PhD principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted hemodynamic management and Routine care in people with Nephrectomy and Nephroureterectomy, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong-Xin Wang, MD,PhD (86 10 83572784, wangdongxin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute kidney injury (early primary outcome) (time frame: Up to 7 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05149196, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.