Status:
COMPLETED
CALIPSO: Calfactant for Acute Lung Injury in Pediatric Stem Cell Transplant and Oncology Patients
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Acute Lung Injury
Eligibility:
All Genders
18-21 years
Phase:
PHASE2
PHASE3
Brief Summary
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
- Clinical diagnosis of congestive heart failure and/or pulmonary capillary wedge pressure \>15 mmHg, or uncorrected congenital heart disease.
- Glasgow Coma Score \< 8 (prior to respiratory failure).
- Pre-existing limitations on care options, (Do Not Attempt Resuscitation Orders, etc).
- Patients with impending death from another disease.
- 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 milliequivalent (mEq)/L for more than 2 hours,
- persistent arterial oxygen desaturation, arterial partial pressure of oxygen (PaO2) \< 50 or oxygen saturation (SaO2) saturation \< 80%,
- hyperkalemia, serum K+ \> 6.5 plus widening of QRS complex on EKG (QRS complex corresponds to the depolarization of the right and left ventricles of the heart).
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00999713
Start Date
June 1 2010
End Date
October 1 2015
Last Update
March 16 2018
Active Locations (16)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States
2
Children's Hospital of Los Angeles
Los Angeles, California, United States
3
University of California San Francisco
San Francisco, California, United States
4
Riley Children's Hospital
Indianapolis, Indiana, United States