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Methylene blue versus vasopressin analog for refractory septic shock in the preterm neonate: A randomized controlled trial
Ismail R, Awad H, Allam R, Youssef O, Ibrahim M, Shehata B
Journal of neonatal-perinatal medicine. 2021
Abstract
BACKGROUND Refractory septic shock in neonates is still associated with high mortality, necessitating an alternative therapy, despite all currently available treatments. This study aims to assess the vasopressor effect of methylene blue (MB) in comparison to terlipressin (TP) as adjuvant therapy for refractory septic shock in the preterm neonate. METHODS A double-blinded randomized controlled trial was conducted in the Neonatal Intensive Care Units at Ain Shams University, Egypt. Thirty preterm neonates with refractory septic shock were randomized to receive either MB or TP as an adjuvant to conventional therapy. Both MB and TP were administered as an intravenous loading dose followed by continuous intravenous infusion. The hemodynamic variables, functional echocardiographic variables, and oxidant stress marker were assessed over a 24 h period together with the side effects of MB. RESULTS MB causes significant improvement in mean arterial blood pressure with a significant decrease of the norepinephrine requirements (1.15±0.21μm/kg/min at baseline vs. 0.55±0.15μm/kg/min at 24 h). MB infusion causes an increase of the pulmonary pressure (44.73±8.53 mmHg at baseline vs. 47.27±7.91 mmHg after 24 h) without affecting the cardiac output. Serum malonaldehyde decreased from 5.45±1.30 nmol/mL at baseline to 4.40±0.90 nmol/mL at 24 h in the MB group. CONCLUSION Administration of MB to preterm infants with refractory septic shock showed rapid increases in systemic vascular resistance and arterial blood pressure with minimal side effects.
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2.
Outcome of Early Hemostatic Intervention in Children With Sepsis and Nonovert Disseminated Intravascular Coagulation Admitted to PICU: A Randomized Controlled Trial
El-Nawawy AA, Elshinawy MI, Khater DM, Moustafa AA, Hassanein NM, Wali YA, Nazir HF
Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies. 2020
Abstract
Critically ill children with sepsis may develop catastrophic thrombotic and hemorrhagic syndrome of disseminated intravascular coagulopathy as a final common pathway. OBJECTIVES Evaluation of the outcome of early hemostatic management of disseminated intravascular coagulopathy in patients with severe sepsis/septic shock admitted to PICU, before the development of clinically overt disseminated intravascular coagulopathy. DESIGN Prospective interventional, open label randomized controlled clinical trial. SETTING PICU at Alexandria University Children's Hospital. PATIENTS The study included 80 patients with proven severe sepsis/septic shock in nonovert disseminated intravascular coagulopathy stage. They were randomly assigned into two groups (group 1 and group 2). INTERVENTIONS Specific intervention was applied for group 1 (plasma transfusion, low-dose unfractionated heparin, and tranexamic acid). MEASUREMENTS All patients had assessment of Pediatric Index of Mortality 2 score, Pediatric Logistic Organ Dysfunction score, inotropic score, routine laboratory, and hemostatic tests including fibrin degradation products and D-dimers. Disseminated intravascular coagulopathy risk assessment scores were calculated on daily basis. RESULTS Mortality rate was significantly higher in group 2. Progression to overt disseminated intravascular coagulopathy was significantly more common among group 2 patients than group 1 (45% and 10%, respectively) (p < 0.0001). Disseminated intravascular coagulopathyRisk Assessment Scores were significantly higher on the second and fifth days among group 2 patients. The initial specific hemostatic intervention was the only significant predictor of survival and prevention of progression to overt disseminated intravascular coagulopathy. CONCLUSIONS Our results suggest that early use of a combination of fresh frozen plasma transfusion, low-dose heparin, and tranexamic acid in children with severe sepsis/septic shock in the "window of opportunity" before the development of overt disseminated intravascular coagulopathy stage was associated with better outcome for survival and prevention of progression to overt disseminated intravascular coagulopathy, with no increase in bleeding risk. Larger multicenter studies are needed to further prove this practice.
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Red blood cell transfusion thresholds in pediatric patients with sepsis
Karam O, Tucci M, Ducruet T, Hume HA, Lacroix J, Gauvin F
Pediatric Critical Care Medicine. 2011;12((5):):512-8.
Abstract
OBJECTIVES In children with severe sepsis or septic shock, the optimal red blood cell transfusion threshold is unknown. We analyzed the subgroup of patients with sepsis and transfusion requirements in a pediatric intensive care unit study to determine the impact of a restrictive vs. liberal transfusion strategy on clinical outcome. DESIGN Subgroup analysis of a prospective, multicenter, randomized, controlled trial. SETTING Multicenter pediatric critical care units. PATIENTS Stabilized critically ill children (mean systemic arterial pressure >2 sd below normal mean for age and cardiovascular support not increased for at least 2 hrs before enrollment) with a hemoglobin <= 9.5 g/dL within 7 days after pediatric critical care unit admission. INTERVENTIONS One hundred thirty-seven stabilized critically ill children with sepsis were randomized to receive red blood cell transfusion if their hemoglobin decreased to either <7.0 g/dL (restrictive group) or 9.5 g/dL (liberal group). MEASUREMENTS AND MAIN RESULTS In the restrictive group (69 patients), 30 patients did not receive any red blood cell transfusion, whereas only one patient in the liberal group (68 patients) never underwent transfusion (p < .01). No clinically significant differences were found for the occurrence of new or progressive multiple organ dysfunction syndrome (18.8% vs. 19.1%; p = .97), for pediatric critical care unit length of stay (p = .74), or for pediatric critical care unit mortality (p = .44) in the restrictive vs. liberal group. CONCLUSIONS In this subgroup analysis of children with stable sepsis, we found no evidence that a restrictive red cell transfusion strategy, as compared to a liberal one, increased the rate of new or progressive multiple organ dysfunction syndromes. Furthermore, a restrictive transfusion threshold significantly reduced exposure to blood products. Our data suggest that a hemoglobin level of 7.0 g/dL may be safe stabilized for children with sepsis, but further studies are required to support this recommendation.
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Effect of fresh frozen plasma and gammaglobulin on humoral immunity in neonatal sepsis
Acunas BA, Peakman M, Liossis G, Davies ET, Bakoleas B, Costalos C, Gamsu HR, Vergani D
Archives of Disease in Childhood Fetal and Neonatal Edition. 1994;70((3):):F182-187.
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5.
Randomized trial of granulocyte transfusions versus intravenous immune globulin therapy for neonatal neutropenia and sepsis
Cairo MS, Worcester CC, Rucker RW, Hanten S, Amlie RN, Sender L, Hicks DA
Journal of Pediatrics. 1992;120((2, Pt 1):):281-5.
Abstract
We prospectively studied newborn infants with sepsis and neutropenia who were randomly selected to receive standard supportive care and either adjuvant granulocyte transfusions or intravenous immune globulin (IVIG) infusions; 21 infants received granulocyte transfusions and 14 received IVIG infusions. Half of the patients were premature (gestational age less than or equal to 32 weeks); the average postnatal age was 5 days (range 3 to 8 days). All infants had neutropenia by the criteria of Manroe et al., and the mean average bone marrow neutrophil storage pool ranged between 35% and 37%. There were no significant differences with respect to serum IgG, IgA, IgM, and total hemolytic complement values between treatment groups or between survivors and nonsurvivors. Clinical severity as defined by hypoxia, acidosis, and hypotension was similar between treatment groups. Group B streptococcus was the most common organism identified and accounted for almost 33% of all bacterial isolates. There was a significantly different survival rate in the group receiving polymorphonuclear leukocyte transfusions (100%, 21/21) compared with the group receiving IVIG infusions (64%, 9/14; p = less than 0.03). There were no significant complications in either treatment group with respect to fluid overload, secondary infection, blood group sensitization, pulmonary complications, or graft-versus-host disease. This pilot study suggests a possible benefit of granulocyte transfusions compared with 'IVIG therapy in the adjuvant treatment of neonatal neutropenia and overwhelming bacterial sepsis.
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6.
Neonatal sepsis treated with buffycoat transfusions
Grunnet N, Kaad PH, Pedersen S, Pedersen JO
ISBT Congress. 1988;:134.. Abstract No. P-T-3-125.
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7.
Role of circulating complement and polymorphonuclear leukocyte transfusion in treatment and outcome in critically ill neonates with sepsis
Cairo MS, Worcester C, Rucker R, Bennetts GA, Amlie R, Perkin R, Anas N, Hicks D
Journal of Pediatrics. 1987;110((6):):935-41.
Abstract
We examined the effects of early administration of polymorphonuclear leukocyte (PMN) transfusions in neonates with sepsis by prospectively randomizing 35 consecutive critically ill infants with sepsis, 21 of whom received PMN transfusions in addition to supportive care, one transfusion every 12 hours for a total of five transfusions. Each transfusion consisted of 15 mL/kg containing 0.5 to 1.0 X 10(9) PMN with less than 10% lymphocytes, and was subjected to 1500 rads. PMNs were obtained by continuous-flow centrifugation leukopheresis. Pretreatment values that did not significantly affect survival included weight, gestational age, sex, prematurity, C-reactive protein, initial hematocrit, platelet count and absolute granulocyte count (AGC less than or equal to 1500/mm3), IgM, IgG, IgA, neutrophil supply pool depletion, hypoxia, acidosis, and hypotension. Postnatal age was significantly lower in the nontransfused group than in the transfused group; 2.3 +/- 0.6 vs 6.1 +/- 2.2, (P less than 0.001). Positive blood cultures were obtained in 80% of both groups. Low circulating levels of total hemolytic complement were associated with a poor outcome and higher mortality: 56 +/- 4.0 IU in survivors vs 31 +/- 4.4 IU in nonsurvivors (P less than 0.01). Survival was significantly greater in the PMN transfused group than in the nontransfused group: 20 (95%) of 21 vs nine (64%) of 14 (P less than or equal to 0.05). No untoward effects were attributable to PMN transfusions, either during the study or on subsequent follow-up visits. These preliminary data suggest that early treatment with PMN transfusions improves survival in neonates with overwhelming sepsis. In addition, depleted or low circulating levels of complement may influence prognosis and thus future treatment strategies for neonatal sepsis.
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8.
Buffy coat transfusions in neonates with sepsis and neutrophil storage pool depletion
Wheeler JG, Chauvenet AR, Johnson CA, Block SM, Dillard R, Abramson JS
Pediatrics. 1987;79((3):):422-5.
Abstract
A randomized study was initiated in neonates with neutropenia (absolute peripheral neutrophil count less than 1,500/microL) and suspected bacterial infection. Twenty infants with proven infection were enrolled, nine of whom had depletion of bone marrow stores of maturing neutrophils (less than or equal to 7% metamyelocyte, band and mature forms per 100 nucleated cells). These nine were randomized to receive 15 mL/kg of either buffy coat transfusions (group 2) or plasma and blood products (group 3). The remaining 11 (group 1) were observed. Peripheral neutrophil counts were monitored to determine the neutrophil response to transfusions. There were ten of 11 patients in group 1, two of four in group 2, and two of five in group 3 who lived at least seven days. No complications of transfusion were noted. No difference in the rate of peripheral neutrophil increase was found among the three groups. The study was stopped when it became clear that sufficient numbers of patients could not be entered into the study, in a reasonable period of time, to prove or disprove a clinically significant improvement in outcome. Although in vitro testing of the buffy coat preparations showed normal function in three of four cases, the clinical quality of the buffy coats may have been inadequate because of poor availability of whole fresh blood less than 24 hours old. The role of neutrophil transfusions in these patients remains unclear.
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9.
Buffy coat transfusions in neutropenic neonates with presumed sepsis: a prospective, randomized trial
Baley JE, Stork EK, Warkentin PI, Shurin SB
Pediatrics. 1987;80((5):):712-20.
Abstract
Neonatal sepsis, accompanied by neutropenia, is associated with a high mortality. To determine whether granulocyte transfusions improve the survival of critically ill neutropenic infants, we prospectively randomized 25 infants to transfusion and nontransfusion groups, matching for birth weight (less than or equal to 1,500 g or greater than 1,500 g). Infants with necrotizing enterocolitis were randomized separately. Neutropenia was established by two successive absolute neutrophil counts less than or equal to 1,500 cells prior to randomization. The transfusion (n = 12) and nontransfusion (n = 13) groups did not differ with respect to clinical or hematologic characteristics. In 23 of 25, bone marrow aspirations were performed to determine the percentage of neutrophil storage pool. Granulocyte transfusions of buffy coats from single units of whole blood (0.1 to 0.9 X 10(9) polymorphonuclear leukocytes per kilogram) were given daily until the absolute neutrophil count increased to more than 1,500/microL. Only five infants, mostly those with necrotizing enterocolitis, required more than one transfusion. A circulating immature to total neutrophil ratio (I:T) greater than or equal to 0.80 was not predictive of an infant with a neutrophil storage pool less than or equal to 7%, and neither an I:T less than 0.80 nor a neutrophil storage pool greater than 7% were predictive of survival. Granulocyte transfusions did not improve survival when either comparing the whole group, those 17 infants with cultures positive for bacteria or viruses, the 19 infants with a circulating I:T greater than or equal to 0.80, or the nine infants with a neutrophil storage pool less than or equal to 7%.(ABSTRACT TRUNCATED AT 250 WORDS)