NCT01735162

Brief Summary

Acute kidney injury (AKI) is a common clinical event with severe consequences. In the pediatric intensive care unit (PICU), AKI occurs in almost 10% of all patients and evidence suggests that children are dying not just with AKI, but from AKI. Unfortunately, the treatment for AKI is limited to a great extent by delayed diagnosis. Reliance on markers of kidney injury that change only when significant damage has already occurred has rendered potential therapies ineffective. For this reason, identification of new markers of AKI that change early in the course of injury is paramount. While new AKI biomarkers have been identified, their performance in the general PICU population is variable. The investigators recently proposed the concept of 'renal angina' as a way to risk stratify patients in the ICU for AKI risk. In the AKI-CHERUB study, the investigators propose to study renal angina in PICU patients alone and in combination with urinary biomarkers for AKI prediction. The investigators hypothesize that renal angina will increase the predictive precision of urinary biomarkers for AKI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
184

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2012

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

Study Start

First participant enrolled

October 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 12, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 28, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

February 3, 2015

Status Verified

February 1, 2015

Enrollment Period

7 months

First QC Date

November 12, 2012

Last Update Submit

February 2, 2015

Conditions

Renal AnginaAcute Kidney Injury

Keywords

Renal anginaAKIPediatric Intensive Care

Outcome Measures

Primary Outcomes (1)

  • Acute kidney injury

    Development of AKI by KDIGO Stage 2 criteria (Creatinine \> 200% baseline)

    At day 3 of PICU admission

Secondary Outcomes (1)

  • PICU length of stay

    60 days

Other Outcomes (2)

  • Mortality

    60 day

  • Renal replacement therapy

    During ICU stay

Study Arms (3)

Very high risk

Very high risk PICU patients are on mechanical ventilation and at least one inotrope or vasopressor at time of admission

High Risk

High risk PICU patients have a history of transplantation (solid organ or bone marrow)

Moderate risk

Moderate risk PICU patients are all other admissions to the ICU (may have either mechanical ventilation or inotropy/vasopressor use but not both). Cannot have a history of transplant. Minimum expected stay 48 hours.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All children admitted to a tertiary children's hospital pediatric intensive care unit with an expected length of stay \> 48 hours.

You may qualify if:

  • Minimum stay 48 hours
  • Indwelling urinary catheter

You may not qualify if:

  • History of renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (4)

  • Goldstein SL. Acute kidney injury biomarkers: renal angina and the need for a renal troponin I. BMC Med. 2011 Dec 21;9:135. doi: 10.1186/1741-7015-9-135.

    PMID: 22189039BACKGROUND

  • Basu RK, Chawla LS, Wheeler DS, Goldstein SL. Renal angina: an emerging paradigm to identify children at risk for acute kidney injury. Pediatr Nephrol. 2012 Jul;27(7):1067-78. doi: 10.1007/s00467-011-2024-5. Epub 2011 Oct 20.

    PMID: 22012033BACKGROUND

  • Goldstein SL, Chawla LS. Renal angina. Clin J Am Soc Nephrol. 2010 May;5(5):943-9. doi: 10.2215/CJN.07201009. Epub 2010 Mar 18.

    PMID: 20299370BACKGROUND

  • Gist KM, Selewski DT, Brinton J, Menon S, Goldstein SL, Basu RK. Assessment of the Independent and Synergistic Effects of Fluid Overload and Acute Kidney Injury on Outcomes of Critically Ill Children. Pediatr Crit Care Med. 2020 Feb;21(2):170-177. doi: 10.1097/PCC.0000000000002107.

    PMID: 31568240DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urinary samples, intended for discard so waiver of consent obtained. Urine samples spun and frozen at -80C. Samples to be run for biomarker ELISA kits.

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

  • Stuart Goldstein, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Acute Care Nephrology

Study Record Dates

First Submitted

November 12, 2012

First Posted

November 28, 2012

Study Start

October 1, 2012

Primary Completion

May 1, 2013

Study Completion

October 1, 2014

Last Updated

February 3, 2015

Record last verified: 2015-02

Locations

US(1)