NCT01576094|CompletedPhase 1/2DMC
Two Inodilators Postsurgery in Neonates
Phase I Study of Two Inodilators in Neonates Undergoing Cardiovascular Surgery
Loading search results
Sponsor study identifier
interventional
20
1 country
1
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2010
Actual (reported)Study Completion
November 2010
Actual (reported)Congenital heart defects are the most prevalent group of congenital malformations in newborns. Surgery-related low cardiac output syndrome (LCOS) could be one of the reason for the unfavourable outcome of this population. The early use of inodilators (INDs), specifically milrinone (MR), is proposed to reduce afterload and increase inotropism. Studies in the paediatric population appear to support a clinical usefulness of MR similar to that observed in adults. Levosimendan (LEVO) is a novel class IND developed for the treatment of heart failure. Experience with LEVO in paediatric patients is scarce. The purpose of this study was to systematically test the efficacy and safety of milrinone (MR) and levosimendan (LEVO) in newborns undergoing cardiovascular surgery with cardiopulmonary bypass (CPB). Given the uncertainty about LEVO pharmacokinetics in neonates, the study was designed as a pilot, phase I feasibility study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
November 2010
Actual (reported)November 2010
Actual (reported)March 31, 2012
Actual (reported)April 12, 2012
Actual (reported)Perfusion-oxygenation
Changes in cerebral and thigh oxyhaemoglobin (O2Hb), deoxyhaemoglobin (HHb), total haemoglobin (THb) and tissue oxygenation index (TOI). The cerebral and peripheral intravascular oxygenation as c∆HbD was also assessed.
NIRS evaluation started immediately after surgery and was maintained during 24 h. At 48 h after surgery, a new NIRS evaluation during 4 hours. At 96 h post-surgery, during 4h.
Blood gases
preoperative (baseline) and then one determination every 6 hours until 24 h post-surgery. One determination at 48h post-surgery. One determination at 96 h post-surgery.
Blood pressure
preoperative (baseline) to post-operative day 6.
temperature
preoperative (baseline) to post-operative day 6.
arterial oxygen saturation
preoperative (baseline) to post-operative day 6.
cooximetry
preoperative (baseline) and then one determination every 6 hours until 24 h post-surgery. One determination at 48h post-surgery. One determination at 96 h post-surgery.
Milrinone (MR) lactate 1 mg/ml: dose 1, starting immediately after central lines were placed and maintained for the duration of the surgical procedure; dose 2, on NICU admission; dose 3, after 2 hours of stability with dose 2, and maintained up to 48 hours. Accordingly, patients randomised to MR received 0.5 , 0.75 and 1 microg/kg per min
Before surgery, patients received milrinone (MR) (milrinone lactate 1 mg/ml). Intravenous continuous infusion of the study drug through a separate central line started intraoperatively and was increased step-wise at predefined time points: dose 1, starting immediately after central lines were placed and maintained for the duration of the surgical procedure; dose 2, on NICU admission providing the patient was in stable haemodynamic condition; dose 3, starting after 2 hours of stability with dose 2, and maintained up to 48 hours IND infusion started. Accordingly, patients randomised to MR received 0.5 , 0.75 and 1 microg/kg per min
Hospital Universitario La Paz
Madrid, Madrid, 28046, Spain
Bravo MC, Lopez P, Cabanas F, Perez-Rodriguez J, Perez-Fernandez E, Quero J, Pellicer A. Acute effects of levosimendan on cerebral and systemic perfusion and oxygenation in newborns: an observational study. Neonatology. 2011;99(3):217-23. doi: 10.1159/000314955. Epub 2010 Sep 25.
Adelina Pellicer, PhD
Dept. of Neonatology, La Paz University Hospital, Madrid
Joan Riera, MBE
Bio-Engineer and Nanotechnology Dept., Polytechnic University of Madrid
Paloma López, MD
Dept. of Neonatology, La Paz University Hospital, Madrid
María Carmen Bravo, PhD
Dept. of Neonatology, La Paz University Hospital, Madrid
20 participants (actual enrollment reported by the registry).
First Submitted
March 31, 2012
First Posted
April 12, 2012
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
How Much Cardiac Output is Enough?
Before surgery patients received levosimendan (levosimendan 2.5 mg/ml). Intravenous continuous infusion of the study drug through a separate central line started intraoperatively and was increased step-wise at predefined time points: dose 1, starting immediately after central lines were placed and maintained for the duration of the surgical procedure; dose 2, on NICU admission providing the patient was in stable haemodynamic condition; dose 3, starting after 2 hours of stability with dose 2, and maintained up to 48 hours IND infusion started. Accordingly, patients randomised to LEVO received 0.1 , 0.15 and 0.2 microg/kg per min, for doses 1, 2 and 3, respectively.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Rosario Madero, MD
Division of Biostatistics, La Paz University Hospital, Madrid
Jesús Pérez-Rodríguez, PhD
Dept. of Neonatology, La Paz University Hospital, Madrid
Carlos Labrandero, MD
Dept. Paediatric Cardiology, La Paz University Hospital, Madrid
José Quero, PhD
Dept. of Neonatology, La Paz University Hospital, Madrid
Antonio Buño, PhD
Clinical Pathology Service, La Paz University Hospital, Madrid
Luis Castro, MD
Dept. Paediatric Anaesthesiology, La Paz University Hospital, Madrid
Fernando Cabañas, PhD
Dept. of Neonatology, La Paz University Hospital, Madrid
Primary Completion
November 2010
Actual (reported)Study Completion
November 2010
Actual (reported)Last Updated
April 12, 2012
Record last verified: 2012-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: