Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT02974946
Study type Interventional
Source The Royal Wolverhampton Hospitals NHS Trust
Contact
Status Completed
Phase N/A
Start date January 2017
Completion date September 22, 2019

See also
  Status Clinical Trial Phase
Completed NCT01920542 - Dexmedetomidine on Pediatric Heart Operation N/A
Recruiting NCT04334707 - Kidney Precision Medicine Project
Completed NCT02765464 - Acute Kidney Injury in Critically Ill Patients
Recruiting NCT05970952 - Acute Kidney Injury in Intensive Care Patients
Recruiting NCT05145283 - Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Acute Ischemic Cerebral and Renal Events After Transcatheter Aortic Valve Implantation Phase 2
Active, not recruiting NCT05384899 - Kidney Precision Medicine Project (KPMP) - COVID-19 Protocol
Completed NCT04600271 - Acute Renal Injury After Major Elective Non-Cardiac Surgery
Completed NCT02838667 - Prevention and Early Detection and Intervention of Post-Coronary Artery Bypass Grafting Surgery (CABG) Acute Kidney Injury (AKI) N/A
Not yet recruiting NCT05666232 - Renal and Cardiac Risk Factors of AKI After Liver Transplantation
Recruiting NCT05186636 - Dialyzing Wisely - Improving the Delivery of Acute Renal Replacement Therapy to Albertans
Completed NCT01807195 - Acute Renal Injury Associated Contrast in Intensive Care Unit Patients N/A
Not yet recruiting NCT05308810 - Postoperative Kidney Functions in Geriatric Major Gynecologic-Oncologic Surgery
Recruiting NCT02743156 - Minimizing Contrast Utilization With IVUS Guidance in Coronary Angioplasty to Avoid Acute Nephropathy Phase 4
Recruiting NCT02417896 - Short Term Spironolactone for Prevention of Acute Kidney Injury After Cardiac Surgery N/A