Acute Renal InjuryKIDNEYNCT02974946
Kidney Protection Using the RenalGuard® System in Cardiac Surgery
A study testing RenalGuard in people with Acute Renal Injury, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This is a prospective randomised control trial 1:1 in patients at risk of developing Acute Kidney Injury after cardiac surgery comparing the RenalGuard® System to current medical treatment. 110 patients will be recruited for each group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Injury
- What is being tested?
- RenalGuard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2017to 22 Sep 2019
- 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
- Patients undergoing surgery (elective or in-house urgent)
- Patient 18 years old and over
- Patient able to give written consent
- Patient at risk of developing AKI after cardiac surgery (at least one factor)
- Diabetics (IDDM or NIDDM) with normal kidney function pre-op
- Patients with eGFR 20-60
Show all 10Show fewer
- Patients undergoing combined cardiac procedures when the CPB time is likely to exceed 120 minutes
- Patients with Hb of 12.5 g/dl or below
- Logistic Euroscore of 5 and above
- Patient not involved with another study
Who cannot join
- Emergency surgery
- Patient unable to give written consent
- Patient already dialysis dependent or eGFR <20
- Patient partaking in another study
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, WV10 0QP
About this study
This is a prospective randomised control trial 1:1 in patients at risk of developing Acute Kidney Injury after cardiac surgery comparing the RenalGuard® System to current medical treatment. 110 patients will be recruited for each group. The aim of the study is to assess whether the RenalGuard® system reduces Acute Kidney Injury (AKI) after cardiac surgery as compared to current practice.
Read the detailed description
Patients undergoing elective or in-house urgent cardiac surgery will be approached for the KIDNEY study if they fulfil the inclusion criteria. Upon consent pre-operative blood tests will be as per the usual practice. Moreover, 2ml of the serum will be stored for NGAL analysis.
Following the consenting process, patients will be randomised (envelop- based) into either having the RenalGuard® System (Study group) or current medical management (Control group).
Study group:
Patients in the study group will have the RenalGuard® System started in anaesthetic room once the peripheral line and arterial lines are sited. The RenalGuard® System will continue to run throughout the cardiac procedure in the operating room and up to 6 hours post-op after the patient has been transferred to the unit. Patients will be managed at a zero balance i.e. volume of the urine output will be matched to the volume of Hartmann's fluid infusion. Forced diuresis is then initiated.
Control group:
Patients in the control group will be managed as per current medical practice which will include no forced diuresis in operating room and the use of inotropes for maintenance of mean arterial pressure and intravenous furosemide for diuresis.
An additional blood test (NGAL) at six hours post-op will be taken and would require 2mls of blood. The NGAL specimens will be dealt with by the biochemistry lab (centrifuged \& stored) so that the specimens can be analysed in batches.
Patients kidney function (U\&Es) will be tested at the time of post-operatively as per usual practice (Day1, pre-discharge and as clinically indicated) and at the post-operative surgical out-patient visit.
Pre-operative, intra-operative and post-operative data will be collected for each patient group.
- Conditions
- Acute Renal Injury
- Being tested
- RenalGuard
- 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.
RenalGuardDevice
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Patients will receive the RenalGuard system Receives: Device: RenalGuard |
| Control group | No intervention | Standard practice will be performed with no RenalGuard system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AKI as defined by the RIFLE criteria
Measured: 50% rise in pre-op serum creatinine within 3 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startJan 2017
- Primary completion12 Jun 2019
- Study completion22 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Renal InjuryStudies of the same condition, open and under way.
- 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
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Heyman Luckraz, Principal investigator, Royal Wolverhampton NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974946
- Sponsor's protocol ID
- 2016CAR88
- Acronym
- KIDNEY
- Status last verified
- Sep 2021
- First submitted
- 23 Nov 2016
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Luckraz H, Giri R, Wrigley B, Nagarajan K, Senanayake E, Sharman E, Beare L, Nevill A. Reduction in acute kidney injury post cardiac surgery using balanced forced diuresis: a randomized, controlled trial. Eur J Cardiothorac Surg. 2021 Apr 13;59(3):562-569. doi: 10.1093/ejcts/ezaa395.
PubMed 33236105Luckraz H, Giri R, Wrigley B, Nagarajan K, Senanayake E, Sharman E, Beare L, Nevill A. Balanced forced-diuresis compared to control as a reno-protective approach in cardiac surgery: secondary outcome of a randomized controlled trial, assessment of neutrophil gelatinase-associated lipocalin levels. J Cardiothorac Surg. 2021 Aug 24;16(1):240. doi: 10.1186/s13019-021-01620-w.
PubMed 34429137Luckraz H, Giri R, Wrigley B, Nagarajan K, Senanayake E, Sharman E, Beare L, Nevill A. Balanced forced-diuresis as a renal protective approach in cardiac surgery: Secondary outcomes of electrolyte changes. J Card Surg. 2021 Nov;36(11):4125-4131. doi: 10.1111/jocs.15925. Epub 2021 Aug 19.
PubMed 34414606Luckraz H, Giri R, Wrigley B, Hennessy AM, Nicholas J, Nevill A. The use of the RenalGuard system in cardiac surgery with cardiopulmonary bypass: a first in man prospective, observational, feasibility pilot study. Open Heart. 2017 Oct 10;4(2):e000669. doi: 10.1136/openhrt-2017-000669. eCollection 2017.
PubMed 29071091
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kidney Protection Using the RenalGuard® System in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02974946
- Acronym / sponsor ID
- KIDNEY / 2016CAR88
- Conditions
- Acute Renal Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS TrustOther government
- Study start
- Jan 2017 (actual)
- Primary completion
- 12 Jun 2019 (actual)
- Study completion
- 22 Sep 2019 (actual)
- First posted
- 29 Nov 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.
This is a prospective randomised control trial 1:1 in patients at risk of developing Acute Kidney Injury after cardiac surgery comparing the RenalGuard® System to current medical treatment. 110 patients will be recruited for each group. The aim of the study is to assess whether the RenalGuard® system reduces Acute Kidney Injury (AKI) after cardiac surgery as compared to current practice.
Detailed description
Patients undergoing elective or in-house urgent cardiac surgery will be approached for the KIDNEY study if they fulfil the inclusion criteria. Upon consent pre-operative blood tests will be as per the usual practice. Moreover, 2ml of the serum will be stored for NGAL analysis.
Following the consenting process, patients will be randomised (envelop- based) into either having the RenalGuard® System (Study group) or current medical management (Control group).
Study group:
Patients in the study group will have the RenalGuard® System started in anaesthetic room once the peripheral line and arterial lines are sited. The RenalGuard® System will continue to run throughout the cardiac procedure in the operating room and up to 6 hours post-op after the patient has been transferred to the unit. Patients will be managed at a zero balance i.e. volume of the urine output will be matched to the volume of Hartmann's fluid infusion. Forced diuresis is then initiated.
Control group:
Patients in the control group will be managed as per current medical practice which will include no forced diuresis in operating room and the use of inotropes for maintenance of mean arterial pressure and intravenous furosemide for diuresis.
An additional blood test (NGAL) at six hours post-op will be taken and would require 2mls of blood. The NGAL specimens will be dealt with by the biochemistry lab (centrifuged \& stored) so that the specimens can be analysed in batches.
Patients kidney function (U\&Es) will be tested at the time of post-operatively as per usual practice (Day1, pre-discharge and as clinically indicated) and at the post-operative surgical out-patient visit.
Pre-operative, intra-operative and post-operative data will be collected for each patient group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: RenalGuardPatients will receive the RenalGuard system |
| Control group | No intervention | –Standard practice will be performed with no RenalGuard system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients undergoing surgery (elective or in-house urgent)
- Patient 18 years old and over
- Patient able to give written consent
- Patient at risk of developing AKI after cardiac surgery (at least one factor)
- Patient not involved with another study
Key exclusion criteria (5 listed)
- Emergency surgery
- Patient unable to give written consent
- Patient already dialysis dependent or eGFR <20
- Patient partaking in another study
- Pregnant patients
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 |
|---|---|---|
| RenalGuard | Device | Study group |
Primary outcome
Incidence of AKI as defined by the RIFLE criteria
Time frame: 50% rise in pre-op serum creatinine within 3 days of 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 9 Sep 2021.
- Results publication: PubMed 33236105Luckraz H, Giri R, Wrigley B, Nagarajan K, Senanayake E, Sharman E, Beare L, Nevill A. Reduction in acute kidney injury post cardiac surgery using balanced forced diuresis: a randomized, controlled trial. Eur J Cardiothorac Surg. 2021 Apr 13;59(3):562-569. doi: 10.1093/ejcts/ezaa395.
- Results publication: PubMed 34429137Luckraz H, Giri R, Wrigley B, Nagarajan K, Senanayake E, Sharman E, Beare L, Nevill A. Balanced forced-diuresis compared to control as a reno-protective approach in cardiac surgery: secondary outcome of a randomized controlled trial, assessment of neutrophil gelatinase-associated lipocalin levels. J Cardiothorac Surg. 2021 Aug 24;16(1):240. doi: 10.1186/s13019-021-01620-w.
- Results publication: PubMed 34414606Luckraz H, Giri R, Wrigley B, Nagarajan K, Senanayake E, Sharman E, Beare L, Nevill A. Balanced forced-diuresis as a renal protective approach in cardiac surgery: Secondary outcomes of electrolyte changes. J Card Surg. 2021 Nov;36(11):4125-4131. doi: 10.1111/jocs.15925. Epub 2021 Aug 19.
- Derived from this study: PubMed 29071091Luckraz H, Giri R, Wrigley B, Hennessy AM, Nicholas J, Nevill A. The use of the RenalGuard system in cardiac surgery with cardiopulmonary bypass: a first in man prospective, observational, feasibility pilot study. Open Heart. 2017 Oct 10;4(2):e000669. doi: 10.1136/openhrt-2017-000669. eCollection 2017.
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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.
Heyman Luckraz principal investigator
Royal Wolverhampton NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RenalGuard in people with Acute Renal Injury, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
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 10 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: finished, as of the sponsor's last update on 9 Sep 2021. 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 United Kingdom. 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 AKI as defined by the RIFLE criteria (time frame: 50% rise in pre-op serum creatinine within 3 days of 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 NCT02974946, which also lists 4 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 9 Sep 2021.