NCT01573104

Brief Summary

The investigators have a new technique of looking at urine to see whether it contains protein fragments that are released by damaged kidneys. These fragments seem to be more accurate than the current blood tests that the investigators use to diagnose renal failure. This technique needs to be validated with a group of patients that have a relatively high incidence of renal failure, cardiopulmonary bypass. The investigators hypothesise that using novel markers of renal dysfunction will identify patients who go on to develop renal failure earlier, and in a higher number than the standard blood tests. The investigators aim to collect urine from patients before going onto bypass, and then at Day 1 and Day 2 after bypass. This urine will be analysed for protein fragments, as well as other new markers of renal dysfunction. The investigators will also take blood at baseline and for the first two days in Cardiac Intensive Care, and compare the accuracy of the new tests with the 'gold standard' that is creatinine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 6, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

1.2 years

First QC Date

April 3, 2012

Last Update Submit

May 26, 2015

Conditions

Acute Kidney Injury

Keywords

DiagnosisAcute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • Development of acute kidney injury

    Development of AKI will be defined by stage 1 of AKIN criteria (ie serum Creatinine \>25% of baseline, or oliguria \<0.5ml/kg/hr for 6 hours.

    Within two days of cardiopulmonary bypass

Study Arms (1)

Biomarker group

EXPERIMENTAL

Patients undergoing CPB having proteomic assays, blood sampling and biomarker assays performed on D0, D1, D2 and D3

Other: Proteomic assayOther: Blood samplingOther: Biomarker sampling

Interventions

Proteomic assayOTHER

Urine will be taken for proteomic assay at baseline, day 1 and day 2

Biomarker group
Blood samplingOTHER

Point of care testing of blood for NGAL/BNP at baseline, day 1 and day 2

Biomarker group
Biomarker samplingOTHER

Urine will be taken at baseline and day 1, day 2 for evaluation of renal biomarkers at later date

Biomarker group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • undergoing elective cardiopulmonary bypass
  • mental capacity
  • able to understand written English

You may not qualify if:

  • patient refusal
  • surgical refusal
  • chronic renal replacement therapy
  • emergency procedures
  • peri-operative use of ventricular assist devices
  • pregnancy
  • pre-operative exercise function NYHA IV
  • severe chronic renal failure (eGFR \<30ml/min/1.73m2).
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Golden Jubilee National Hospital

Glasgow, G81 4DY, United Kingdom

Location

MeSH Terms

Conditions

Acute Kidney InjuryDisease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • John Kinsella, MD, FRCA

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Research Fellow

Study Record Dates

First Submitted

April 3, 2012

First Posted

April 6, 2012

Study Start

November 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2015

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

GB(1)