Acute Kidney InjuryNCT02803372
Circulatory Management and Acute Kidney Injury in Patients Undergoing Partial Nephrectomy
A study testing Goal-directed circulatory management and Routine circulatory management in people with Acute Kidney Injury, run by Peking University First Hospital at 1 site in China.
Trial summary
The purpose of this study is to investigate whether circulatory management based on LiDCOrapid hemodynamic monitoring can reduce the incidence of acute kidney injury in patients undergoing partial nephrectomy when compared with routine circulatory management based on blood pressure and urine output monitoring Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Goal-directed circulatory management and Routine circulatory management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 > 18 years;
- Planning to undergo partial nephrectomy;
Who cannot join
- Patients with renal function damage (chronic kidney disease stage 3-5) before surgery;
- Patients with arrhythmia or aortic valve diseases (moderate or higher degree stenosis/regurgitation);
- Patients who has participated in other trials.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: Impact of Circulatory Management Based on LiDCOrapid Hemodynamic Monitoring on the Incidence of Acute Kidney Injury in Patients Undergoing Partial Nephrectomy: A Randomized Controlled Trial
The purpose of this study is to investigate whether circulatory management based on LiDCOrapid hemodynamic monitoring can reduce the incidence of acute kidney injury in patients undergoing partial nephrectomy when compared with routine circulatory management based on blood pressure and urine output monitoring
Read the detailed description
Previous studies found that the incidence of acute kidney injury afer partial nephrectomy is higher than 30%. In addition to nephron loss induced by renal parenchyma resection, ischemia/reperfusion injury produced by clamping/unclamping of renal arteries is also an important reason. However, studies investigating the effect of circulatory management on the incidence of acute kidney injury after partial nephrectomy are limited.
It has been shown that perioperative hemodynamic optimization protected renal function in surgical patients. And in patients undergoing renal transplantation, adequate hydration and optimal perfusion enhances early graft function. The investigators hypothesize that hydration and circulatory management to guarantee optimal renal perfusion may decrease the occurrence of acute kidney injury after partial nephrectomy. The purpose of this study is to investigate whether circulatory management based on LiDCOrapid hemodynamic monitoring can reduce the incidence of acute kidney injury in patients undergoing partial nephrectomy when compared with routine circulatory management based on blood pressure and urine output monitoring.
- Conditions
- Acute Kidney Injury
- Being tested
- Goal-directed circulatory management, Routine circulatory management
- Keywords
- partial nephrectomy, acute kidney injury, LiDCOrapid, circulatory management
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-directed circulatory managementOther
In addition to routine monitoring, invasive LiDCOrapid is used to monitor MAP, SVV and CI. Intraoperative circulatory management is performed according to the goal-directed principal, i.e., to maintain MAP > 95 mmHg, SVV < 6%, and CI 3.0-4.0 L/min/m2, started from renal artery clamping and maintained until the end of surgery. Crystalloid solution is firstly infused to maintain SVV at the target level, dobutamine and/or noradrenaline are then infused to maintain MAP and CI at the target levels.
Routine circulatory managementOther
Routine monitoring is performed, which include invasive blood pressure and urine output. Intraoperative circulatory management is performed according to routine practice, i.e., to maintain blood pressure within 20% from baseline level and urine output > 0.5 ml/kg/h by infusing crystalloid solution and administering vasoactive drugs when considered necessary.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | In addition to routine monitoring, invasive LiDCOrapid is used to monitor mean arterial pressure (MAP), stroke volume variation (SVV) and cardiac index (CI). Intraoperative goal-directed circulatory management is performed, i.e., to maintain MAP > 95 mmHg, SVV < 6%, and CI 3.0-4.0 L/min/m2, started from renal artery clamping and maintained until the end of surgery. Receives: Other: Goal-directed circulatory management |
| Control group | Active comparator | Routine monitoring is performed, which includes invasive blood pressure and urine output. Intraoperative routine circulatory management is performed, i.e., to maintain blood pressure within 20% from baseline level and urine output > 0.5 ml/kg/h. Receives: Other: Routine circulatory management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute kidney injury after surgery
Acute kidney injury is diagnosed according to KDIGO (Kidney Disease: Improving Global Outcomes) criteria
Measured: During the first 3 days after surgery
Secondary outcomes (3)
Serum creatinine concentration
Serum creatinine concentration
Measured: At 3 and 6 months after surgery
Length of stay in hospital after surgery
Length of stay in hospital after surgery
Measured: From end of surgery to 30 days after surgery
Incidence of postoperative complications
Incidence of complications within 30 days after surgery
Measured: From end of surgery to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2016
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies 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
- None (open label)
- Enrolment
- 144 participants (actual)
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
- NCT02803372
- Sponsor's protocol ID
- 2016[1118]
- Status last verified
- Dec 2017
- First submitted
- 6 Jun 2016
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data of individual participants for all primary and secondary outcome measures will be made available on request after study completion and paper publication.
Publications
Rajan S, Babazade R, Govindarajan SR, Pal R, You J, Mascha EJ, Khanna A, Yang M, Marcano FD, Singh AK, Kaouk J, Turan A. Perioperative factors associated with acute kidney injury after partial nephrectomy. Br J Anaesth. 2016 Jan;116(1):70-6. doi: 10.1093/bja/aev416.
PubMed 26675951De Gasperi A, Narcisi S, Mazza E, Bettinelli L, Pavani M, Perrone L, Grugni C, Corti A. Perioperative fluid management in kidney transplantation: is volume overload still mandatory for graft function? Transplant Proc. 2006 Apr;38(3):807-9. doi: 10.1016/j.transproceed.2006.01.072.
PubMed 16647477Aulakh NK, Garg K, Bose A, Aulakh BS, Chahal HS, Aulakh GS. Influence of hemodynamics and intra-operative hydration on biochemical outcome of renal transplant recipients. J Anaesthesiol Clin Pharmacol. 2015 Apr-Jun;31(2):174-9. doi: 10.4103/0970-9185.155144.
PubMed 25948896O'Loughlin E, Ward M, Crossley A, Hughes R, Bremner AP, Corcoran T. Evaluation of the utility of the Vigileo FloTrac() , LiDCO() , USCOM and CardioQ() to detect hypovolaemia in conscious volunteers: a proof of concept study. Anaesthesia. 2015 Feb;70(2):142-9. doi: 10.1111/anae.12949.
PubMed 25583188Chin JH, Jun IG, Lee J, Seo H, Hwang GS, Kim YK. Can stroke volume variation be an alternative to central venous pressure in patients undergoing kidney transplantation? Transplant Proc. 2014 Dec;46(10):3363-6. doi: 10.1016/j.transproceed.2014.09.097.
PubMed 25498052Wu QF, Kong H, Xu ZZ, Li HJ, Mu DL, Wang DX. Impact of goal-directed hemodynamic management on the incidence of acute kidney injury in patients undergoing partial nephrectomy: a pilot randomized controlled trial. BMC Anesthesiol. 2021 Mar 3;21(1):67. doi: 10.1186/s12871-021-01288-8.
PubMed 33658007
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Circulatory Management Based on LiDCOrapid Hemodynamic Monitoring on the Incidence of Acute Kidney Injury in Patients Undergoing Partial Nephrectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02803372
- Acronym / sponsor ID
- 2016[1118]
- Conditions
- Acute Kidney Injury
- Keywords
- partial nephrectomy, acute kidney injury, LiDCOrapid, circulatory management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 17 Jun 2016 (estimated)
- 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.
The purpose of this study is to investigate whether circulatory management based on LiDCOrapid hemodynamic monitoring can reduce the incidence of acute kidney injury in patients undergoing partial nephrectomy when compared with routine circulatory management based on blood pressure and urine output monitoring
Detailed description
Previous studies found that the incidence of acute kidney injury afer partial nephrectomy is higher than 30%. In addition to nephron loss induced by renal parenchyma resection, ischemia/reperfusion injury produced by clamping/unclamping of renal arteries is also an important reason. However, studies investigating the effect of circulatory management on the incidence of acute kidney injury after partial nephrectomy are limited.
It has been shown that perioperative hemodynamic optimization protected renal function in surgical patients. And in patients undergoing renal transplantation, adequate hydration and optimal perfusion enhances early graft function. The investigators hypothesize that hydration and circulatory management to guarantee optimal renal perfusion may decrease the occurrence of acute kidney injury after partial nephrectomy. The purpose of this study is to investigate whether circulatory management based on LiDCOrapid hemodynamic monitoring can reduce the incidence of acute kidney injury in patients undergoing partial nephrectomy when compared with routine circulatory management based on blood pressure and urine output monitoring.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Goal-directed circulatory managementIn addition to routine monitoring, invasive LiDCOrapid is used to monitor mean arterial pressure (MAP), stroke volume variation (SVV) and cardiac index (CI). Intraoperative goal-directed circulatory management is performed, i.e., to maintain MAP > 95 mmHg, SVV < 6%, and CI 3.0-4.0 L/min/m2, started from renal artery clamping and maintained until the end of surgery. |
| Control group | Active comparator | Other: Routine circulatory managementRoutine monitoring is performed, which includes invasive blood pressure and urine output. Intraoperative routine circulatory management is performed, i.e., to maintain blood pressure within 20% from baseline level and urine output > 0.5 ml/kg/h. |
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 > 18 years;
- Planning to undergo partial nephrectomy;
Key exclusion criteria (3 listed)
- Patients with renal function damage (chronic kidney disease stage 3-5) before surgery;
- Patients with arrhythmia or aortic valve diseases (moderate or higher degree stenosis/regurgitation);
- Patients who has participated in other trials.
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 |
|---|---|---|
| Goal-directed circulatory managementIn addition to routine monitoring, invasive LiDCOrapid is used to monitor MAP, SVV and CI. Intraoperative circulatory management is performed according to the goal-directed principal, i.e., to maintain MAP > 95 mmHg, SVV < 6%, and CI 3.0-4.0 L/min/m2, started from renal artery clamping and maintained until the end of surgery. Crystalloid solution is firstly infused to maintain SVV at the target level, dobutamine and/or noradrenaline are then infused to maintain MAP and CI at the target levels. | Other | Intervention group |
| Routine circulatory managementRoutine monitoring is performed, which include invasive blood pressure and urine output. Intraoperative circulatory management is performed according to routine practice, i.e., to maintain blood pressure within 20% from baseline level and urine output > 0.5 ml/kg/h by infusing crystalloid solution and administering vasoactive drugs when considered necessary. | Other | Control group |
Primary outcome
Incidence of acute kidney injury after surgery
Time frame: During the first 3 days after surgery
Acute kidney injury is diagnosed according to KDIGO (Kidney Disease: Improving Global Outcomes) criteria
3 secondary outcomes
Serum creatinine concentration
Time frame: At 3 and 6 months after surgery
Length of stay in hospital after surgery
Time frame: From end of surgery to 30 days after surgery
Incidence of postoperative complications
Time frame: From end of surgery to 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- Background: PubMed 26675951Rajan S, Babazade R, Govindarajan SR, Pal R, You J, Mascha EJ, Khanna A, Yang M, Marcano FD, Singh AK, Kaouk J, Turan A. Perioperative factors associated with acute kidney injury after partial nephrectomy. Br J Anaesth. 2016 Jan;116(1):70-6. doi: 10.1093/bja/aev416.
- Background: PubMed 16647477De Gasperi A, Narcisi S, Mazza E, Bettinelli L, Pavani M, Perrone L, Grugni C, Corti A. Perioperative fluid management in kidney transplantation: is volume overload still mandatory for graft function? Transplant Proc. 2006 Apr;38(3):807-9. doi: 10.1016/j.transproceed.2006.01.072.
- Background: PubMed 25948896Aulakh NK, Garg K, Bose A, Aulakh BS, Chahal HS, Aulakh GS. Influence of hemodynamics and intra-operative hydration on biochemical outcome of renal transplant recipients. J Anaesthesiol Clin Pharmacol. 2015 Apr-Jun;31(2):174-9. doi: 10.4103/0970-9185.155144.
- Background: PubMed 25583188O'Loughlin E, Ward M, Crossley A, Hughes R, Bremner AP, Corcoran T. Evaluation of the utility of the Vigileo FloTrac() , LiDCO() , USCOM and CardioQ() to detect hypovolaemia in conscious volunteers: a proof of concept study. Anaesthesia. 2015 Feb;70(2):142-9. doi: 10.1111/anae.12949.
- Background: PubMed 25498052Chin JH, Jun IG, Lee J, Seo H, Hwang GS, Kim YK. Can stroke volume variation be an alternative to central venous pressure in patients undergoing kidney transplantation? Transplant Proc. 2014 Dec;46(10):3363-6. doi: 10.1016/j.transproceed.2014.09.097.
- Derived from this study: PubMed 33658007Wu QF, Kong H, Xu ZZ, Li HJ, Mu DL, Wang DX. Impact of goal-directed hemodynamic management on the incidence of acute kidney injury in patients undergoing partial nephrectomy: a pilot randomized controlled trial. BMC Anesthesiol. 2021 Mar 3;21(1):67. doi: 10.1186/s12871-021-01288-8.
- Individual participant dataSharing planned: Yes. Data of individual participants for all primary and secondary outcome measures will be made available on request after study completion and paper publication.
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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. This study is not recruiting at the moment.
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 Goal-directed circulatory management and Routine circulatory management in people with Acute Kidney Injury, 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 3 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: finished, as of the sponsor's last update on 3 Jan 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute kidney injury after surgery (time frame: During the first 3 days after surgery). 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 NCT02803372, which also lists 6 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 Jan 2018.