NCT02364427

Brief Summary

Acute Kidney Injury is a condition where your kidneys suddenly stop working properly and usually occurs if you are already unwell with an illness and can happen after having surgery. Having an episode of acute kidney injury increases the risk of progression to chronic kidney disease (CKD) later on and decreases long-term survival. It also has a major socioeconomic impact with regards to admissions and length of hospital stay. There is currently no universally accepted treatment or method of identifying patients that are at risk. The investigators aim to measure arterial stiffness in patients prior to them undergoing cardiac surgery to investigate whether this measurement is associated with an increased risk of patients developing acute kidney injury after surgery. The investigators are planning to measure arterial stiffness, and examine a blood sample, for kidney health-related levels to determine whether there is an association between those patients who have stiff arterial vessels and those patients who may develop acute kidney injury after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

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

February 4, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

March 11, 2019

Status Verified

March 1, 2018

Enrollment Period

3.4 years

First QC Date

February 4, 2015

Last Update Submit

March 8, 2019

Conditions

Keywords

Pulse wave velocityArterial stiffnessAKI

Outcome Measures

Primary Outcomes (1)

  • Pulse Wave Velocity (arterial stiffness)

    Baseline visit

Secondary Outcomes (1)

  • Kidney function measured by renal blood profile

    baseline

Study Arms (1)

Arterial stiffness

Arterial stiffness - Vicorder to measure pulse wave velocity

Device: Arterial stiffness - Vicorder to measure pulse wave velocity

Interventions

Pulse wave velocity (PWV)measures the stiffness of the arteries. This provides a simple and quick noninvasive method of obtaining the PWV for an arterial segment.

Also known as: Vicorder
Arterial stiffness

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients undergoing pure (non-valvular repair) CABG surgery

You may qualify if:

  • All patients undergoing pure (non-valvular repair) CABG surgery
  • Male or female
  • Aged \>18 years
  • Written informed consent

You may not qualify if:

  • Patients who have aortic grafts or renal stents
  • Patients at CKD stage 4 or 5 or on dialysis
  • Bilateral amputee
  • Unable to lie supine for 10-15 mins
  • Psychiatric illness, including anxiety, mood and untreated eating disorders
  • Infection or course of antibiotics within the last month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Related Publications (1)

  • Greenwood SA, Mangahis E, Castle EM, Wang J, Campbell J, Deshpande R, Jayawardene S. Arterial stiffness is a predictor for acute kidney injury following coronary artery bypass graft surgery. J Cardiothorac Surg. 2019 Mar 7;14(1):51. doi: 10.1186/s13019-019-0873-3.

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

  • Sharlene A Greenwood, PhD

    Consultant renal physiotherapist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 18, 2015

Study Start

April 1, 2015

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

March 11, 2019

Record last verified: 2018-03

Locations