Clinical trial NCT02974946: Kidney Protection Using the RenalGuard® System in Cardiac Surgery
Official title: Kidney Protection Using the RenalGuard® System in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Renal Injury
Lead sponsor: The Royal Wolverhampton Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2016-11-29
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing surgery (elective or in-house urgent)
2. Patient 18 years old and over
3. Patient able to give written consent
4. Patient at risk of developing AKI after cardiac surgery (at least one factor)

   1. Diabetics (IDDM or NIDDM) with normal kidney function pre-op
   2. Patients with eGFR 20-60
   3. Patients undergoing combined cardiac procedures when the CPB time is likely to exceed 120 minutes
   4. Patients with Hb of 12.5 g/dl or below
   5. Logistic Euroscore of 5 and above
5. Patient not involved with another study

Exclusion Criteria:

1. Emergency surgery
2. Patient unable to give written consent
3. Patient already dialysis dependent or eGFR \<20
4. Patient partaking in another study
5. Pregnant patients

Primary outcomes:
measure: Incidence of AKI as defined by the RIFLE criteria
timeFrame: 50% rise in pre-op serum creatinine within 3 days of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton NHS Trust
state: West Midlands
Study officials:
affiliation: Royal Wolverhampton NHS Trust
name: Heyman Luckraz
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Luckraz 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.
citation: Luckraz 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.
citation: Luckraz 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.