Kidney Protection Using the RenalGuard® System in Cardiac Surgery (KIDNEY)
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|ClinicalTrials.gov Identifier: NCT02974946|
Recruitment Status : Completed
First Posted : November 29, 2016
Last Update Posted : September 9, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Acute Renal Injury||Device: RenalGuard||Not Applicable|
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).
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Kidney Protection Using the RenalGuard® System in Cardiac Surgery|
|Actual Study Start Date :||January 2017|
|Actual Primary Completion Date :||June 12, 2019|
|Actual Study Completion Date :||September 22, 2019|
Experimental: Study group
Patients will receive the RenalGuard system
No Intervention: Control group
Standard practice will be performed with no RenalGuard system
- Incidence of AKI as defined by the RIFLE criteria [ Time Frame: 50% rise in pre-op serum creatinine within 3 days of surgery ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
- Emergency surgery
- Patient unable to give written consent
- Patient already dialysis dependent or eGFR <20
- Patient partaking in another study
- Pregnant patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974946
|The Royal Wolverhampton NHS Trust|
|Wolverhampton, West Midlands, United Kingdom, WV10 0QP|
|Principal Investigator:||Heyman Luckraz||Royal Wolverhampton NHS Trust|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||The Royal Wolverhampton Hospitals NHS Trust|
|Other Study ID Numbers:||
|First Posted:||November 29, 2016 Key Record Dates|
|Last Update Posted:||September 9, 2021|
|Last Verified:||September 2021|
Acute Kidney Injury
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases