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Accuracy of Urinary NGAL in Predicting CardioRenal Syndrome in Acute Heart Failure at Emergency - CYNDERELA-HF Study

NCT01364636 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2018-03-21

No results posted yet for this study

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.

Conditions

  • Cardiorenal Syndrome

Sponsors & Collaborators

  • Universidade Federal Fluminense

    collaborator OTHER

  • Hospital Universitário Antonio Pedro

    collaborator OTHER

  • Diagnósticos da América S.A.

    collaborator UNKNOWN

  • Pro-Cardiaco Hospital

    lead OTHER

Principal Investigators

  • Evandro T Mesquita, PhD · Fluminense Federal University - Cardiovascular Sciences Department, coordinator of post graduation courses; Hospital PróCardíaco - Medical Director

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-05-31
Completion
2012-09-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01364636 on ClinicalTrials.gov