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

This study is not yet open for participant recruitment.
Verified November 2016 by The Royal Wolverhampton Hospitals NHS Trust
Sponsor:
ClinicalTrials.gov Identifier:
NCT02974946
First Posted: November 29, 2016
Last Update Posted: November 29, 2016
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.
Information provided by (Responsible Party):
The Royal Wolverhampton Hospitals NHS Trust
  Purpose
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.

Condition Intervention
Acute Renal Injury Device: RenalGuard

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Kidney Protection Using the RenalGuard® System in Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by The Royal Wolverhampton Hospitals NHS Trust:

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

Estimated Enrollment: 220
Study Start Date: January 2017
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study group
Patients will receive the RenalGuard system
Device: RenalGuard
No Intervention: Control group
Standard practice will be performed with no RenalGuard system

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Heyman Luckraz heyman.luckraz@nhs.net
Contact: Lorraine Jacques lorraine.jacques@nhs.net

Sponsors and Collaborators
The Royal Wolverhampton Hospitals NHS Trust
Investigators
Principal Investigator: Heyman Luckraz Royal Wolverhampton NHS Trust
  More Information

Responsible Party: The Royal Wolverhampton Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02974946     History of Changes
Other Study ID Numbers: 2016CAR88
First Submitted: November 23, 2016
First Posted: November 29, 2016
Last Update Posted: November 29, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases