Accuracy of Urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) in Predicting Cardio-renal Syndrome in Acute Decompensated Heart Failure at Emergency - CYNDERELA-HF Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- CardioRenal Syndrome type 1 development
Study Overview
Brief Summary
Rationale: Heart Failure (HF) elevated prevalence in Brasil and the world; 20-30% AHF patients develop CardioRenal Syndrome (CRS) type 1; Worsening Renal Failure (WRF) is a prognostic marker of mortality in Acute HF;NGAL is a novel biomarker of Acute Kidney Injury released in 2 hours, and addressed in several different clinical scenarios(contrast injury, cardiopulmonary bypass, critical illness.
Hypothesis: Admission NGAL predicts CRS in AHF patients admitted to the Emergency Room (ER).
Primary goal: To evaluate the diagnostic accuracy and the best cutoff value of urinary NGAL to predict the development of CRS type 1 in patients admitted to the Emergency Room.
Secondary goals: 1- To evaluate the prognostic impact of NGAL on in-hospital adverse outcomes (length of hospitalization, death, institution of renal replacement therapy, use of vasoactive drugs, mechanical ventilation).2- Evaluate the prognostic impact of NGAL in adverse outcomes in 30 days, 60 days and 6 months (death, rehospitalization, institution of renal replacement therapy).3- Identify clinical and hemodynamic characteristics of Acute HF that can influence the evolutionary behavior of NGAL levels in 48 hours.4- Identify the association of drugs commonly used for HF management, which might influence the evolutionary behavior of NGAL levels in 48 hours.5-Assess the impact of NGAL results in clinical decision making.
Methods: Observational, prospective, blinded study. Population: Acute HF patients admitted to the ER of Hospital Pró Cardiaco and Hospital Antonio Pedro - Universidade Federal Fluminense.
Statistics: Convenience Sample size (n=180); determination of best cut-off: ROC analysis; Predictive performance of the cut-off: sensibility, specificity, likelihood ratio, predictive value, accuracy; Identification of variables to predict CRS: logistic regression and square-Qui test; Correlations analysis of normally distributed variables: Pearson's linear correlation test; Mean values for normally distributed variables: Mann-Wittney test; Significance on p<0,05; Intra-assay variation analysis.
Study chronogram: Recruitment: 12 months; Results analysis and conclusions: 60 days; Manuscript preparation for paper submission: 30 days.
Detailed Description
Rationale: Heart Failure (HF) elevated prevalence in Brasil and the world; 20-30% AHF patients develop CardioRenal Syndrome (CRS) type 1; Worsening Renal Failure (WRF) is a prognostic marker of mortality in Acute HF; available biomarker shows irreversible damage, late in CRS evolution.(creatinine);NGAL is a novel biomarker of Acute Kidney Injury released in 2 hours, and addressed in several different clinical scenarios(contrast injury, cardiopulmonary bypass, critical illness...); Acute HF patient's risk stratification will allow appropriate resource allocation and establishment of criteria for hospital admission and discharge.
Hypothesis: Admission NGAL predicts CRS in AHF patients admitted to the Emergency Room (ER).
Primary goal: To evaluate the diagnostic accuracy and the best cutoff value of urinary NGAL to predict the development of CRS type 1 in patients admitted to the Emergency Room.
Secondary goals: 1- To evaluate the prognostic impact of NGAL on in-hospital adverse outcomes (length of hospitalization, death, institution of renal replacement therapy, use of vasoactive drugs, mechanical ventilation).2- Evaluate the prognostic impact of NGAL in adverse outcomes in 30 days, 60 days and 6 months (death, rehospitalization, institution of renal replacement therapy).3- Identify clinical and hemodynamic characteristics of Acute HF that can influence the evolutionary behavior of NGAL levels in 48 hours.4- Identify the association of drugs commonly used for HF management, which might influence the evolutionary behavior of NGAL levels in 48 hours.5-Assess the impact of NGAL results in clinical decision making.
Methods: Observational, prospective, blinded study. Population: Acute HF patients admitted to the ER of Hospital Pró Cardiaco and Hospital Antonio Pedro - Universidade Federal Fluminense.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •acute heart failure according to the Framingham's criteria
- •informed consent signed
Exclusion Criteria
- •Acute coronary syndrome
- •cardiogenic shock
- •terminal renal disease
- •transplanted patients
- •known nephrotoxicity exposure
- •urinary tract infection
Outcomes
Primary Outcomes
CardioRenal Syndrome type 1 development
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
CardioRenal Syndrome type 1 development defined by the elevation of serum creatinine of 0,3mg/dL and/or of 50% of baseline values
Secondary Outcomes
- in-hospital death(participants will be followed for the duration of hospital stay, an expected average of 5 weeks)
- length of hospitalization(participants will be followed for the duration of hospital stay, an expected average of 5 weeks)
- institution of renal replacement therapy(patients will be followed up to 360 days after hospital discharge)
- need to use of vasoactive drugs(participants will be followed for the duration of hospital stay, an expected average of 5 weeks)
- mechanical ventilation(participants will be followed for the duration of hospital stay, an expected average of 5 weeks)
- death(patients will be followed up to 360 days after hospital discharge)
- rehospitalization(patients will be followed up to 360 days after hospital discharge)