Kidney Protection Using the RenalGuard® System in Cardiac Surgery (KIDNEY)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02974946|
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : February 15, 2019
|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)|
|Estimated 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|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 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 ]
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||Recruiting|
|Wolverhampton, West Midlands, United Kingdom, WV10 0QP|
|Contact: Heyman Luckraz email@example.com|
|Principal Investigator:||Heyman Luckraz||Royal Wolverhampton NHS Trust|