Clinical Trial: Accuracy of Urinary NGAL in Predicting CardioRenal Syndrome in Acute Heart Failure at Emergency - CYNDERELA-HF Study
Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Observational
Official Title: Accuracy of Urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) in Predicting Cardio-renal Syndrome in Acute Decompensated Heart Failure at Emergency - CYNDERELA-HF
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 performanc
Detailed 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; 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 Pr&#
Sponsor: Pro-Cardiaco Hospital
Current Primary Outcome: CardioRenal Syndrome type 1 development [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- length of hospitalization [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]number of days of the study entry hospitalization
- in-hospital death [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]Death within the study entry hospitalization period
- institution of renal replacement therapy [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]need for any kind of dyalisis procedure.
- need to use of vasoactive drugs [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]if the patient was submitted to use of vasoactive drugs as dopamine, dobutamine, noradrenaline, milrinone, and other vasoactive drugs
- mechanical ventilation [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]if the patient was submitted to mechanical ventilation during the hospitalization period
- death [ Time Frame: patients will be followed up to 360 days after hospital discharge ]death after study entry hospitalization discharge
- rehospitalization [ Time Frame: patients will be followed up to 360 days after hospital discharge ]need to be admitted to any hospital after study entry hospitalization discharge
- institution of renal replacement therapy [ Time Frame: patients will be followed up to 360 days after hospital discharge ]need to be submitted to any dyalisis procedure after study entry hospitalization discharge
Original Secondary Outcome: Same as current
Information By: Pro-Cardiaco Hospital
Dates:
Date Received: May 9, 2011
Date Started: February 2011
Date Completion: September 2012
Last Updated: June 6, 2011
Last Verified: April 2011
