Goal-directed Hemodynamic Management and Kidney Injury After Radical Nephrectomy or Nephroureterectomy
NCT ID: NCT05149196
Last Updated: 2025-06-03
Study Results
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Basic Information
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RECRUITING
NA
1724 participants
INTERVENTIONAL
2025-02-10
2034-12-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Targeted blood pressure management
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.
Targeted hemodynamic management
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 care
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.
Routine care
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.
Interventions
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Targeted hemodynamic management
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 care
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.
Eligibility Criteria
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Inclusion Criteria
2. Scheduled to undergo unilateral radical nephrectomy for renal cancer or unilateral radical nephroureterectomy for upper tract urothelial carcinoma.
Exclusion Criteria
2. Uncontrolled severe hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg);
3. Combined with cardiovascular diseases with Revised Cardiac Risk Index (RCRI) \>1 or metabolic equivalents (METs) \<4;
4. Unable to communicate due to severe dementia, language barrier, or end-stage disease before surgery;
5. Other conditions that are considered unsuitable for inclusion (specific reasons should be indicated).
18 Years
ALL
No
Sponsors
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Peking University First Hospital
OTHER
Responsible Party
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Dong-Xin Wang
Professor
Principal Investigators
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Dong-Xin Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Beijing University First Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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2021-417
Identifier Type: -
Identifier Source: org_study_id
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