Trial Outcomes & Findings for Acute Kidney Injury Neutrophil Gelatinase-Associated Lipocalin Evaluation of Symptomatic Heart Failure Study (NCT NCT01291836)
NCT ID: NCT01291836
Last Updated: 2024-01-03
Results Overview
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.
COMPLETED
930 participants
First week of hospitalization.
2024-01-03
Participant Flow
Participant milestones
| Measure |
Enrollment Group
Subjects with sufficient data to be included in the analysis.
|
Subjects Enrolled But Not Included in the Analysis.
Subjects that were consented and some study procedures completed but did not have required study procedures completed and subsequent data available for inclusion in the primary analysis.
|
|---|---|---|
|
Overall Study
STARTED
|
930
|
71
|
|
Overall Study
COMPLETED
|
930
|
71
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acute Kidney Injury Neutrophil Gelatinase-Associated Lipocalin Evaluation of Symptomatic Heart Failure Study
Baseline characteristics by cohort
| Measure |
Enrollment Group-No Treatment Arms.
n=930 Participants
All subjects underwent the same protocol procedures no stratification.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
344 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
586 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
354 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
576 Participants
n=99 Participants
|
|
Region of Enrollment
Greece
|
27 participants
n=99 Participants
|
|
Region of Enrollment
Netherlands
|
97 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
587 participants
n=99 Participants
|
|
Region of Enrollment
Ireland
|
41 participants
n=99 Participants
|
|
Region of Enrollment
Italy
|
110 participants
n=99 Participants
|
|
Region of Enrollment
Switzerland
|
52 participants
n=99 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=99 Participants
|
|
Region of Enrollment
Spain
|
15 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: First week of hospitalization.Population: Participants were enrolled from patients presenting to the ED with signs and/or symptoms of Heart Failure. Subjects also had to meet specific operational requirements for the blood drawing time frame, per the protocol.
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.
Outcome measures
| Measure |
Enrollment Group
n=930 Participants
Subjects enrolled in the study and completing required procedures to be included in the primary analysis.
|
|---|---|
|
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.
|
0.658 Probability classifying AKI from non-AKI
Interval 0.586 to 0.73
|
PRIMARY outcome
Timeframe: ~30 daysPopulation: Participants were enrolled from patients presenting to the ED with signs and/or symptoms of Heart Failure. Subjects also had to meet specific operational requirements for the blood drawing time frame, per the protocol.
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.
Outcome measures
| Measure |
Enrollment Group
n=930 Participants
Subjects enrolled in the study and completing required procedures to be included in the primary analysis.
|
|---|---|
|
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.
|
0.650 Probability classifying AKI from non-AKI
Interval 0.598 to 0.702
|
Adverse Events
Enrollment Group
Non-participating Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER