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CALIPSO: Calfactant for Acute Lung Injury in Pediatric Stem Cell Transplant and Oncology Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Penn State University
Sponsor:
Collaborator:
Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network
Information provided by (Responsible Party):
Neal J. Thomas, Penn State University
ClinicalTrials.gov Identifier:
NCT00999713
First received: October 18, 2009
Last updated: October 20, 2014
Last verified: October 2014

October 18, 2009
October 20, 2014
June 2010
September 2015   (final data collection date for primary outcome measure)
All-cause mortality at the time of PICU discharge [ Time Frame: PICU discharge ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00999713 on ClinicalTrials.gov Archive Site
  • Total duration of mechanical ventilation required during PICU admission. [ Time Frame: PICU discharge ] [ Designated as safety issue: No ]
  • Total duration of PICU and hospital stay required. [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]
  • Improvement in oxygenation, as measured by oxygenation index, in the initial 48 hours after treatment [ Time Frame: 48 hours after enrollment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
CALIPSO: Calfactant for Acute Lung Injury in Pediatric Stem Cell Transplant and Oncology Patients
A Phase 3 Trial of Calfactant for ALI in Pediatric Leukemia and HSCT Patients

Acute lung injury (ALI) is a common, life-threatening complication among pediatric leukemia and lymphoma and hematopoietic stem cell transplant (HSCT) recipients. Although these children represent a relatively small and unique patient population, they account for the largest proportion of deaths of all pediatric diseases. The long-term goal of this project is to improve outcomes among these patients. Recently, the intratracheal administration of calfactant has resulted in decreased mortality among children with ALI including promising results among children with cancer and following HSCT. Consequently, the primary specific aim of this study is to assess the effect of calfactant on intensive care (PICU) survival among pediatric leukemia and lymphoma and HSCT patients with ALI. Secondary aims include assessment of the effect of calfactant on oxygenation and on the length of mechanical ventilation, PICU stay, and hospital stay. Calfactant therapy has been found to be of benefit in acute lung injury in the overall pediatric population by improving oxygenation and decreasing mortality. These findings, in conjunction with recent subgroup analysis in which calfactant therapy appeared to improve outcomes in immunocompromised children provide the rationale for assessing calfactant therapy in this patient population.

Funding Source - FDA OOPD

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Lung Injury
  • Drug: Calfactant
    Endotracheal calfactant, up to 3 doses if subject qualifies
  • Other: Air placebo
    Endotracheal air administration
  • Experimental: Calfactant
    Endotracheal calfactant administration
    Intervention: Drug: Calfactant
  • Placebo Comparator: Placebo (air)
    Endotracheal air administration
    Intervention: Other: Air placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
Not Provided
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients must meet criteria for acute lung injury

    • Intubated, mechanically ventilated, with respiratory failure secondary to diffuse, bilateral parenchymal lung disease (as judged by chest x-ray).
    • Oxygenation index (OI) > 13, but < 37, for two consecutive blood gases which should be separated by at least one hour within 48 hours of the initiation of mechanical ventilation.
    • Arterial catheter placement
    • Parental informed consent
  2. Patients must have a diagnosis of leukemia/lymphoma undergoing active treatment or following HSCT for any indication. Leukemia/lymphoma will be defined according to the National Cancer Institute Surveillance Epidemiology and End Results Collaborative Staging Manual including those conditions defined as borderline such as myelodysplastic syndromes. All forms of HSCT will be eligible, allogeneic as well as autologous.

Exclusion Criteria:

  1. Clinical diagnosis of congestive heart failure and/or pulmonary capillary wedge pressure >15 mmHg, or uncorrected congenital heart disease.
  2. Glasgow Coma Score < 8 (prior to respiratory failure).
  3. Pre-existing limitations on care options, (Do Not Attempt Resuscitation Orders, etc).
  4. Patients with impending death from another disease.
  5. Patients moribund or with other organ failure at possible randomization:

    • hypotension unresponsive to treatment (mean BP < 60 or < 5th % for age),
    • persistent cardiac tachyarrhythmia >150/minute, or persistent bradyarrythmia < 50/minute, or age appropriate criteria for younger children,
    • metabolic acidosis > - 10 mEq/L for more than 2 hours,
    • persistent arterial oxygen desaturation, PaO2 < 50 or SaO2saturation < 80%,
    • hyperkalemia, serum K+ > 6.5 plus widening of QRS complex on EKG
Both
18 Months to 21 Years
No
Contact: Neal J Thomas, MD, MSc 7175318521 nthomas@psu.edu
Contact: Robert F Tamburro, MD, MSc 7175318521 rtamburro@psu.edu
United States,   Canada
 
NCT00999713
#1R01FD003410-01, R01 FD003410-01-A1
Yes
Neal J. Thomas, Penn State University
Penn State University
Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network
Principal Investigator: Neal J Thomas, MD, MSc Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Principal Investigator: Robert F Tamburro, MD, MSc Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Penn State University
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP