Acute Kidney Injury Neutrophil Gelatinase-Associated Lipocalin Evaluation of Symptomatic Heart Failure Study

Acute Kidney Injury Clinical Trial

— AKINESIS  

Official title:

Acute Kidney Injury Neutrophil Gelatinase-Associated Lipocalin (N-GAL) Evaluation of Symptomatic Heart Failure Study (AKINESIS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291836
• Other study ID #: DDDP-09EE-081
• Status: Completed
• Start date: December 2010
• Est. completion date: June 2015

Study information

• Verified date: December 2023
• Source: Abbott RDx Cardiometabolic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

AKINESIS is a clinical study to assess the utility of blood and urine NGAL tests in predicting worsening kidney function in patients who present with acute heart failure (AHF) and who are treated with diuretics. It is believed that rising NGAL levels in the blood and/or urine can predict acute kidney injury. It is also believed that patients who are admitted to the hospital with high NGAL levels in the blood/urine will have poorer outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 930
• Est. completion date: June 2015
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects must be at least 18 years of age.
• Subjects must present to the hospital with one or more signs or symptoms of acute heart failure (AHF). Signs and symptoms include shortness of breath from walking, rales or crackles, galloping heart rhythm, jugular venous distension, trouble breathing at rest or when lying down, waking breathless at night, using more than 2 pillows to sleep, tiring easily, swelling of feet, ankles or legs, frequent coughing, a cough that produces mucous or blood-tinged sputum, or a dry cough when lying flat.
• Subjects must receive IV diuretics, or there must be an intent to treat with IV diuretics.
• Subjects must be willing and able to comply with all aspects of the protocol.
• Subjects must provide signed informed consent.

Exclusion Criteria:

• Subjects that present with symptoms consistent with acute coronary syndromes (AMI or UA) as the chief cause of the current episode of AHF.
• Subjects already on dialysis prior to enrollment or if dialysis initiation is already planned during the current hospital visit.
• Subjects that have had any major organ transplant (heart, lung, kidney, or liver).
• Subjects that have participated in a drug treatment study within the past 30 days or if they have already been enrolled as a subject in this study.
• Women who verbally report being pregnant at the time of screening and anyone belonging to a vulnerable population that is deemed inappropriate for inclusion into the study by the IRB/EC.

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Acute Kidney Injury
• Heart Failure
• Wounds and Injuries

Locations

Country	Name	City	State
Greece	Athens University Hospital Attikon	Athens
Ireland	University Hospital Dublin	Dublin
Italy	Clinica Mediterranea	Naples
Italy	Monasterio Foundation for Medical Research and Public Health	Pisa
Netherlands	University of Groningen Medical Center	Groningen	GZ Groningen
Spain	Hospital Clínico Universitario Valencia	Valencia
Switzerland	Universitätsspital Basel	Basel	Petersgraben
United States	New York Methodist Hospital	Brooklyn	New York
United States	Henry Ford Health System	Detroit	Michigan
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Virginia Commonweath University Medical Center	Richmond	Virginia
United States	San Diego Veterans Administration Hospital	San Diego	California
United States	University of California San Diego Medical Center	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
Alere San Diego	Abbott Diagnostics Division, Alere, Inc.

Countries where clinical trial is conducted

United States,  Greece,  Ireland,  Italy,  Netherlands,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating the Efficacy of the Triage NGAL Test as an Aid to Diagnosis of Acute Kidney Injury (AKI) in Patients Admitted to the Hospital With Symptoms of Acute Heart Failure.	Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.	First week of hospitalization.
Primary	Evaluating the Efficacy of the Triage NGAL Test as an Aid in Predicting Poorer Outcomes in Patients Admitted to the Hospital With Admitted With Symptoms of Acute Heart Failure.	Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.	~30 days