AKINESIS is a multi-center prospective, uncontrolled clinical study to assess the utility of a plasma NGAL test (Triage® NGAL Test) and a urinary NGAL test (ARCHITECT® Urine NGAL) in predicting worsening renal function in patients presenting with…
ID
Source
Brief title
Condition
- Heart failures
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnostic:
In patients admitted to the hospital with symptoms of acute heart failure, an
elevated plasma or urine NGAL level is predictive of acute kidney injury (AKI),
defined by a persistent (>=24 hours) rise in the plasma/serum creatinine level
of >=0.5 mg/dl or >=50% above the first creatinine value upon presentation, or
the initiation of renal replacement therapy (RRT-including dialysis,
ultrafiltration and hemofiltration), during the initial 5 days of
hospitalization.
Prognostic:
Patients admitted with symptoms of acute heart failure who have an elevated
plasma or urine NGAL level (independent of or in conjunction with changes in
plasma/serum creatinine) during hospitalization will have poorer outcomes,
defined by a composite index of adverse clinical outcomes following
hospitalization at 30 days (with the follow up period starting at enrollment):
death, initiation of renal replacement therapy including dialysis,
ultrafiltration, and hemofiltration, heart failure-related readmissions, and
emergent heart failure-related outpatient visits where IV diuretics are
administered (emergency room, clinic).
Secondary outcome
1. In patients admitted with symptoms of acute heart failure, an elevated
plasma or urine NGAL level (independent of or in conjunction with changes in
plasma/serum creatinine) during hospitalization will have poorer outcomes,
defined by a composite index of adverse clinical outcomes during
hospitalization: death, severe AKI [defined by a persistent (>=24 hours) and
abrupt (within 5 days) increase in plasma/serum creatinine of >=100% from the
first creatinine value upon presentation or initiation of renal replacement
therapy including dialysis, ultrafiltration and hemofiltration], respiratory
failure requiring mechanical ventilation [invasive or noninvasive], and
cardiogenic shock [defined as requiring inotropes or vasopressors].
2. In patients admitted with an estimated glomular filtration rate (eGFR) of
<60ml/min/1.73m2 BSA using the MDRD equation, eGFR loss at hospital discharge
will be greater in patients who have elevated plasma or urine NGAL level during
hospitalization.
3. In patients admitted to the hospital with symptoms of acute heart failure,
an elevated plasma or urine NGAL level is predictive of acute kidney injury
(AKI), defined by a persistent (>=24 hours) >=50% increase in the plasma/serum
creatinine level above the first creatinine value upon presentation occurring
within the first 5 days of hospitalization.
4. In patients admitted to the hospital with symptoms of acute heart failure,
an elevated plasma or urine NGAL level is predictive of acute kidney injury
(AKI), defined by a persistent (>=24 hours) increase in the plasma/serum
creatinine levels of >=0.3 mg/dl or a >=50% increase above the first creatinine
value upon presentation occurring in less than 48 hours during the first 5 days
of hospitalization.
5. Patients that present with symptoms of acute heart failure that are sent
home from the emergency room without admission to the hospital will be followed
for 30 days to identify the following events: 1. hospital readmission 2) all
cause mortality, 3) and unscheduled visits to the ED or heart failure clinic
for worsening heart failure where intravenous diuretics are given. These
endpoints will be evaluated in response to the first, peak, and delta plasma
and urine NGAL levels. This endpoint is exploratory and there may be
insufficient power for analysis.
6. Patients admitted with symptoms of acute heart failure who have an elevated
plasma or urine NGAL level (independent of or in conjunction with changes in
plasma/serum creatinine) during hospitalization will have decreased organ
failure-free survival during their hospitalization, comprising decreased renal
failure-free survival, respiratory failure free-survival, cardiovascular
failure-free survival, and a composite of all 3 indices.
Data to support the composite index of adverse clinical outcomes at 30 days and
60 days following hospitalization (with the follow-up period starting at
enrollment) will be recorded for each subject. Information may come from a
family member or friend (if applicable) or by hospital and clinic medical
records. The study site must conduct due diligence in collecting this follow up
data as it is part of this study.
Data to support the exploratory analysis of adverse clinical outcomes at 12
months following hospitalization (with the follow-up period starting at
enrollment) will be recorded for each subject. Adverse clinical outcomes for
the 12 month follow-up will be limited to death, initiation of RRT, and heart
failure-related readmissions. Information may come from a family member or
friend (if applicable) or by hospital and clinic medical records. The study
site must conduct due diligence in collecting this follow up data as it is part
of this study.
Background summary
The development of worsening renal function occurs frequently in the setting of
acutely decompensated HF and strongly predicts adverse clinical outcomes. The
care of subjects undergoing treatment for acutely decompensated HF could
greatly benefit from a test (NGAL) that could aid in identifying subjects at
risk of developing worsening renal function. This would potentially permit
optimized management of these subjects to protect renal function (i.e.,
tailored diuretic and fluid management, avoidance of nephrotoxic drugs,
minimization of the use of contrast agents, rescheduling of non-emergent
surgeries or interventions that might result in additional renal injury, etc.).
Study objective
AKINESIS is a multi-center prospective, uncontrolled clinical study to assess
the utility of a plasma NGAL test (Triage® NGAL Test) and a urinary NGAL test
(ARCHITECT® Urine NGAL) in predicting worsening renal function in patients
presenting with acute heart failure (AHF) who are treated with diuretics.
Study design
This is an obeservational study.
Study burden and risks
Subjects will be asked to provide six urine and blood samples for the purpose
of measuring NGAL. Subjects may feel some pain or discomfort during
venipuncture when a needle is inserted into the vein of an arm to collect the
blood samples. Subjects may also experience bruising, lightheadedness, or on
rare occasions, infection at the site of the needle stick. The study poses no
special risk to pregnant women or to an unborn fetus.
100 Abbott Park Drive 100
Abbott Park IL 60064 IL 60064
US
100 Abbott Park Drive 100
Abbott Park IL 60064 IL 60064
US
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01291836 |
| CCMO | NL36031.042.11 |