NCT04551391

Brief Summary

The endothelin (ET) system is an active target in human Acute Kidney Injury (AKI). Our primary hypothesis is that the circulating blood concentration of ET will be higher in patients with AKI than in matched controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2020

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 15, 2023

Status Verified

September 1, 2022

Enrollment Period

3.8 years

First QC Date

March 3, 2020

Last Update Submit

November 14, 2023

Conditions

Acute Kidney InjuryChronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

  • To primary outcome aims to measure whether circulating ET is higher in patients with AKI than in matched controls.

    as above

    3 years

Secondary Outcomes (1)

  • The secondary outcome aims to measure differences in urine ET between patients with AKI and matched controls AKI patients that do not fully recover renal function within 90 days will have the highest concentrations of blood and urine ET.

    3 YEARS

Study Arms (2)

Case

(i) Adult aged 16 or over; (ii) Ability to provide informed consent; (iii) Diagnosis of AKI determined as: * Previous (within 3 years) eGFR \>45 mL/min/1.73m2 OR no history of kidney disease if no recent (within 3 years) blood results available AND * Elevated creatinine over 1.5 x previous result OR over 150 μmol/L if no previous value AND * Increasing creatinine \>= 27μmol/L above index value within 48 hours

Other: Blood and urine sampling

Control

(i) Adult aged 16 or over; (ii) Ability to provide informed consent; (iii) Admitted to hospital without AKI: (eGFR \> 60). This group will be recruited contemporaneously with, and matched to, AKI participants by: 1. Age (± 5 years) 2. Sex 3. AKI aetiology (ischaemic, infected, nephrotoxic) 4 (i) History of diabetes or not AND/OR (ii) History of cardiovascular disease or not

Other: Blood and urine sampling

Interventions

Blood and urine samplingOTHER

Retinal OCT is a novel, non-invasive method for cross-sectionally imaging the eye's retina and choroid

Also known as: retinal opticla coherence tomography
CaseControl

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

(i) Adult aged 16 or over; (ii) Ability to provide informed consent; (iii) Diagnosis of AKI

You may qualify if:

  • (i) Adult aged 16 or over; (ii) Ability to provide informed consent; (iii) Diagnosis of AKI determined as:
  • Previous (within 3 years) eGFR \>45 mL/min/1.73m2 OR no history of kidney disease if no recent (within 3 years) blood results available AND
  • Elevated creatinine over 1.5 x previous result OR over 150 μmol/L if no previous value AND
  • Increasing creatinine \>= 27μmol/L above index value within 48 hours
  • (i) Adult aged 16 or over; (ii) Ability to provide informed consent; (iii) Admitted to hospital without AKI: (eGFR \> 60)
  • This group will be recruited contemporaneously with, and matched to, AKI participants by:
  • Age (± 5 years)
  • Sex
  • AKI aetiology (ischaemic, infected, nephrotoxic) 4 (i) History of diabetes or not AND/OR (ii) History of cardiovascular disease or not

You may not qualify if:

  • Inability to provide informed consent
  • Prisoners
  • Pregnancy or breast feeding
  • Evidence of CKD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Lothian

Edinburgh, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Circulating blood concentration of endothelin and urine

MeSH Terms

Conditions

Acute Kidney InjuryRenal Insufficiency, Chronic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2020

First Posted

September 16, 2020

Study Start

January 7, 2020

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

November 15, 2023

Record last verified: 2022-09

Locations

GB(1)