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Completed

NCT Number: NCT00982527

Fenoldopam in Pediatric Cardiac Surgery

The purpose of this study is to determine whether fenoldopam infusion during cardiopulmonary bypass in young children with congenital heart disease is able to reduce indicators of acute kidney injury (biomarkers reduction, diuresis increase) compared to a control group.

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Key information

Conditions

Kidney Failure, Acute Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

1 day–365 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bambino Gesù Hospital

Rome, Lazio, 00165, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children with congenital heart disease, less than one year old, undergoing surgery with the use of cardiopulmonary bypass

Exclusion criteria

  • Children over one year old, correction for ventricular or atrial septal defect, need for deep hypothermic circulatory arrest, preoperative renal dysfunction.

Treatment and study plan

Placebo

Drug

Saline continuous infusion during cardiopulmonary by pass at 1 ml/h

Other names: saline

Fenoldopam

Drug

Fenoldopam continuous infusion at 1 mcg/kg/min during cardiopulmonary bypass. Infusion preparation is mad in order to match the rate 1 ml/h of placebo infusion.

Other names: corlopam

Primary outcomes

  1. Reduction of urinary and/or serum levels of biomarker NGAL in treated group versus controls

    Time frame: End of surgery and 12 hours postoperatively

Secondary outcomes

  1. Reduction of urinary and/or serum levels of cystatin C, increase of diuresis and improvement of perfusion markers in treated group versus controls

    Time frame: End of surgery and 12 hours postoperatively

Sponsors and collaborators

Lead sponsor

Bambino Gesù Hospital and Research Institute

Other

Registry information

Official study title

Intraoperative Fenoldopam Infusion in Children Requiring Cardiopulmonary Bypass During Cardiac Surgery

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 23, 2009
Registry last updated
Jun 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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