Hemodynamic effects of i.v. milrinone lactate in pediatric patients with septic shock. A prospective, double-blinded, randomized, placebo-controlled, interventional study.
| Title: | Hemodynamic effects of i.v. milrinone lactate in pediatric patients with septic shock. A prospective, double-blinded, randomized, placebo-controlled, interventional study. |
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| Authors: | Barton P; Divisions of Pediatric Critical Care, University of Texas Southwestern Medical Center (Children's Medical Center of Dallas and Parkland Memorial Hospital), USA 75235-9063.; Garcia J; Kouatli A; Kitchen L; Zorka A; Lindsay C; Lawless S; Giroir B |
| Source: | Chest [Chest] 1996 May; Vol. 109 (5), pp. 1302-12. |
| Publication Type: | Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| Language: | English |
| Journal Info: | Publisher: Elsevier Country of Publication: United States NLM ID: 0231335 Publication Model: Print Cited Medium: Print ISSN: 0012-3692 (Print) Linking ISSN: 00123692 NLM ISO Abbreviation: Chest Subsets: MEDLINE |
| Imprint Name(s): | Publication: 2016- : New York : Elsevier; Original Publication: Chicago : American College of Chest Physicians |
| MeSH Terms: | Hemodynamics/*drug effects ; Phosphodiesterase Inhibitors/*administration & dosage ; Pyridones/*administration & dosage ; Shock, Septic/*drug therapy; Cardiac Output/drug effects ; Pulmonary Wedge Pressure/drug effects ; Shock, Septic/physiopathology ; Vascular Resistance/drug effects ; Adolescent ; Child ; Child, Preschool ; Double-Blind Method ; Female ; Humans ; Infant ; Infusions, Intravenous ; Male ; Milrinone ; Prospective Studies |
| Abstract: | Study Objective: To determine the hemodynamic effects of i.v. milrinone lactate in pediatric patients with nonhyperdynamic septic shock. Specifically we tested the hypothesis that i.v. milrinone would increase cardiac index by 20% and decrease systemic vascular resistance index by 20% during a 2-h study period.; Design: Prospective, double-blinded, randomized, placebo-controlled, descriptive, interventional study.; Setting: Twenty-six-bed pediatric ICU at Children's Medical Center of Dallas and a 10-bed pediatric trauma ICU at Parkland Memorial Hospital.; Patients/participants: Twelve patients (age range, 9 months to 15 years) with nonhyperdynamic septic shock despite administration of catecholamines (cardiac index [CI] normal [3.5 to 5.5 L/min/m2] or low [< or=3.5 L/min/m2]; systemic vascular resistance index [SVRI] normal [800 to 1,600 dyne.s.cm5/m2] or high [> or =1,600 dyne.s.cm5/m2]; and pulmonary capillary wedge pressure [PCWP] normal [8 to 12 mm Hg] or higher) with clinical signs of poor perfusion were enrolled, randomized, and treated in a blinded fashion with i.v. milrinone and placebo.; Interventions: Patients were randomized into two groups. Group A received a loading dose of 50 micrograms/kg i.v. of milrinone followed by a continuous i.v. infusion of 0.5 microgram/kg/min while group B received an equal volume loading dose and continuous infusion of placebo. After 2 h, group A received an equal-volume loading dose followed by a continuous infusion of placebo while the milrinone infusion continued, while group B received a 50 micrograms/kg loading dose of milrinone followed by a continuous infusion of 0.5 microgram/kg/min while the placebo infusion remained. Outcome variable were measured at baseline, 0.5, 1.0, 2.0, 2.5, 3.0, and 4.0 h. Echocardiographic measurements were taken at baseline, hour 2, and hour 4 in all subjects. No changes in other inotropic or mechanical ventilatory support were allowed during the study period.; Measurements and Main Results: Milrinone significantly increased CI, stroke volume index (SVI), right and left ventricular stroke work index, and oxygen delivery (Do2) at 0.5, 1.0, and 2.0 h postloading dose (p < 0.05) while significantly decreasing SVRI, pulmonary vascular resistance index, and mean pulmonary arterial pressure at 0.5, 1.0, and 2.0 h postloading dose (p < 0.05). No clinically or statistically significant changes in heart rate, systolic and diastolic BP, mean systemic arterial pressure, or PCWP were observed during milrinone treatment compared to placebo.; Conclusions: CI, SVI, and Do2 significantly increased while SVRI significantly decreased when compared to placebo after i.v. administration of milrinone to pediatric patients with nonhyperdynamic septic shock. No adverse effects were observed. In a volume-resuscitated pediatric patient with septic shock, when administered in addition to catecholamines, milrinone will improve cardiovascular function. |
| Substance Nomenclature: | 0 (Phosphodiesterase Inhibitors); 0 (Pyridones); JU9YAX04C7 (Milrinone) |
| Entry Date(s): | Date Created: 19960501 Date Completed: 19960627 Latest Revision: 20190514 |
| Update Code: | 20260130 |
| DOI: | 10.1378/chest.109.5.1302 |
| PMID: | 8625683 |
| Database: | MEDLINE |
Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't