Kidney Protection Using the RenalGuard® System in Cardiac Surgery (KIDNEY)

September 1, 2021 updated by: The Royal Wolverhampton Hospitals NHS Trust
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Wolverhampton, West Midlands, United Kingdom, WV10 0QP
        • The Royal Wolverhampton NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Study group
Patients will receive the RenalGuard system
Device: RenalGuard
NO_INTERVENTION: Control group
Standard practice will be performed with no RenalGuard system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of AKI as defined by the RIFLE criteria
Time Frame: 50% rise in pre-op serum creatinine within 3 days of surgery
50% rise in pre-op serum creatinine within 3 days of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Royal Wolverhampton Hospitals NHS Trust

Investigators

  • Principal Investigator: Heyman Luckraz, Royal Wolverhampton Nhs Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

June 12, 2019

Study Completion (ACTUAL)

September 22, 2019

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (ESTIMATE)

November 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2021

Last Update Submitted That Met QC Criteria

September 1, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016CAR88

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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