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Biol Blood Marrow Transplant. 2018 Dec;24(12):2479-2486. doi: 10.1016/j.bbmt.2018.07.023. Epub 2018 Jul 29.

CALIPSO: A Randomized Controlled Trial of Calfactant for Acute Lung Injury in Pediatric Stem Cell and Oncology Patients.

Author information

1
Department of Pediatrics, Pediatric Critical Care Medicine, Penn State College of Medicine, Hershey, Pennsylvania; Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania. Electronic address: nthomas@psu.edu.
2
Department of Pediatrics, Pediatric Critical Care Medicine, Penn State College of Medicine, Hershey, Pennsylvania.
3
Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.
4
Department of Pediatrics, Division of Pediatric Critical Care Medicine, Weill Cornell Medicine, New York, New York.
5
Department of Anesthesiology Critical Care Medicine, Children's Hospital Los Angeles, USC Keck School of Medicine, Los Angeles, California.
6
Maria Fareri Children's Hospital at Westchester Medical Center, New York Medical College, Valhalla, New York.
7
Department of Pediatrics, Saint Barnabas Medical Center, Livingston, New Jersey.
8
Department of Pediatrics, Indiana University School of Medicine, Riley Hospital for Children, Indianapolis, Indiana.
9
Department of Pediatrics, Pediatric Critical Care Medicine, Penn State College of Medicine, Hershey, Pennsylvania; Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.

Abstract

To assess if calfactant reduces mortality among children with leukemia/lymphoma or after hematopoietic cell transplantation (HCT) with pediatric acute respiratory distress syndrome (PARDS), we conducted a multicenter, randomized, placebo-controlled, double-blinded trial in 17 pediatric intensive care units (PICUs) of tertiary care children's hospitals. Patients ages 18 months to 25 years with leukemia/lymphoma or having undergone HCT who required invasive mechanical ventilation for bilateral lung disease with an oxygenation index (OI) > 10 and <37 were studied. Interventions used were intratracheal instillation of either calfactant or air placebo (1 or 2 doses). Forty-three subjects were enrolled between November 2010 and June 2015: 26 assigned to calfactant and 17 to placebo. There were no significant differences in the primary outcome, which was survival to PICU discharge (adjusted hazard ratio of mortality for calfactant versus placebo, 1.78; 95% confidence interval, .53 to 6.05; P = .35), OI, functional outcomes, or ventilator-free days, adjusting for risk strata and Pediatric Risk of Mortality (PRISM) score. Despite the risk-stratified randomization, more allogeneic HCT patients received calfactant (76% and 39%, respectively) due to low recruitment at various sites. This imbalance is important because independent of treatment arm and while adjusting for PRISM score, those with allogeneic HCT had a nonsignificant higher likelihood of death at PICU discharge (adjusted odds ratio, 3.02; 95% confidence interval, .76 to 12.06; P = .12). Overall, 86% of the patients who survived to PICU discharge also were successfully discharged from the hospital. These data do not support the use of calfactant among this high mortality group of pediatric leukemia/lymphoma and/or HCT patients with PARDS to increase survival. In spite of poor enrollment, allogeneic HCT patients with PARDS appeared to be characterized by higher mortality than even other high-risk immunosuppressed groups. Conducting research among these children is challenging but necessary, because survival to PICU discharge usually results in successful discharge to home.

KEYWORDS:

Acute lung injury; Hematopoietic stem cell transplantation; Leukemia/lymphoma; Pediatric acute respiratory distress syndrome; Surfactant

PMID:
30059785
DOI:
10.1016/j.bbmt.2018.07.023

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