NCT02974946

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2019

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

2.4 years

First QC Date

November 23, 2016

Last Update Submit

September 1, 2021

Conditions

Acute Renal Injury

Outcome Measures

Primary Outcomes (1)

  • Incidence of AKI as defined by the RIFLE criteria

    50% rise in pre-op serum creatinine within 3 days of surgery

Study Arms (2)

Study group

EXPERIMENTAL

Patients will receive the RenalGuard system

Device: RenalGuard

Control group

NO INTERVENTION

Standard practice will be performed with no RenalGuard system

Interventions

RenalGuardDEVICE
Study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing surgery (elective or in-house urgent)
  • Patient 18 years old and over
  • Patient able to give written consent
  • Patient at risk of developing AKI after cardiac surgery (at least one factor)
  • Diabetics (IDDM or NIDDM) with normal kidney function pre-op
  • Patients with eGFR 20-60
  • Patients undergoing combined cardiac procedures when the CPB time is likely to exceed 120 minutes
  • Patients with Hb of 12.5 g/dl or below
  • Logistic Euroscore of 5 and above
  • Patient not involved with another study

You may not qualify if:

  • Emergency surgery
  • Patient unable to give written consent
  • Patient already dialysis dependent or eGFR \<20
  • Patient partaking in another study
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 33236105RESULT

  • 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.

    PMID: 34429137RESULT

  • 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.

    PMID: 34414606RESULT

  • 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.

    PMID: 29071091DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Heyman Luckraz

    Royal Wolverhampton NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2016

First Posted

November 29, 2016

Study Start

January 1, 2017

Primary Completion

June 12, 2019

Study Completion

September 22, 2019

Last Updated

September 9, 2021

Record last verified: 2021-09

Locations

GB(1)