Low Cardiac Output Syndrome Clinical Trial
Official title:
Phase I Study of Two Inodilators in Neonates Undergoing Cardiovascular Surgery
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | November 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 40 Days |
Eligibility |
Inclusion Criteria: - Newborns undergoing cardiovascular surgery who were in stable pre-operative haemodynamic condition - Parental consent given Exclusion Criteria: - Parental consent refused - Inodilators contraindicated |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario La Paz | Madrid |
Lead Sponsor | Collaborator |
---|---|
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz | Fondo de Investigacion Sanitaria, Hospital Universitario La Paz |
Spain,
Bravo MC, López P, Cabañas F, Pérez-Rodríguez J, Pérez-Fernández 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. Erratum in: Neonatology. 2011;99(4):301. Bravo, María del Carmen [corrected to Bravo, María Carmen]; Quero, José [added]. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No |
Secondary | 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. | No | |
Secondary | Blood pressure | preoperative (baseline) to post-operative day 6. | No | |
Secondary | temperature | central (axilla) and peripheral (foot) temperature | preoperative (baseline) to post-operative day 6. | No |
Secondary | arterial oxygen saturation | preoperative (baseline) to post-operative day 6. | No | |
Secondary | 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. | No | |
Secondary | lactate | 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. | No | |
Secondary | glucose | 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. | No | |
Secondary | haemoglobin concentration | 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. | No | |
Secondary | Biochemical markers | Serum creatinine, N-terminal pro-brain natriuretic peptide (NT-proBNP), troponine I (TnI) and proinflammatory and antinflammatory factors [interleukin (IL) beta 1, IL 6, IL 7, IL 8, IL 10, and tumor necrotic factor alpha | baseline, at 24h after surgery and on day 6 post-surgery | No |
Secondary | Inodilators concentration | Milrinone and Levosimendan plasma concentration | Basal, two hours after dose 2; and at 24 and 48h from the start of the IND infusion in infants receiving IND dose 3. Beyond that period (open study), daily samples were obtained for LEVO up to day 7 postsurgery, and at 10 and 14 days. | No |
Secondary | inotrope score | calculated according to Wernovsky | preoperative (baseline) and then one evaluation every 6 hours until 24 h post-surgery. At 48h post-surgery. At 96 h post-surgery. | No |
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