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

Primary Purpose

Acute Lung Injury

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Calfactant
Air placebo
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lung Injury focused on measuring Acute Lung Injury, Cancer, Pediatrics

Eligibility Criteria

18 Months - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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 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).

Sites / Locations

  • Phoenix Children's Hospital
  • Children's Hospital of Los Angeles
  • University of California San Francisco
  • Riley Children's Hospital
  • Hackensack University Medical Center
  • Weill Cornell Medical Center
  • Maria Fareri Children's Hospital
  • Rainbow Babies Hospital
  • Nationwide Children's Hospital
  • Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
  • Children's Hospital of Philadelphia
  • Children's Hospital of Pittsburgh
  • St. Jude Children's Research Hospital
  • Texas Children's Hospital
  • Children's Hospital of Wisconsin
  • Hospital Sainte Justine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Calfactant

Placebo (air)

Arm Description

Endotracheal calfactant administration

Endotracheal air administration

Outcomes

Primary Outcome Measures

All-cause Mortality at the Time of Pediatric Intensive Care Unit (PICU) Discharge
Overall mortality rate from admission to PICU discharge

Secondary Outcome Measures

Ventilator Free Days (VFDs)
Number of days the patient is alive and off of the ventilator
Total Duration of Stay Required
Length of stay (LOS) ,measured in days, from admission to PICU discharge and admission to hospital discharge.
Change in Oxygenation: First Intervention
The Oxygenation Index after the first intervention is calculated as the fraction of inspired oxygen, in percent, times the mean airway pressure, in mmHg, divided by the partial pressure of oxygen in arterial blood, in mmHg. Lower values are better.
Change in Oxygenation: Second Intervention
The Oxygenation Index after the second intervention (if applicable) is calculated as the fraction of inspired oxygen, in percent, times the mean airway pressure, in mmHg, divided by the partial pressure of oxygen in arterial blood, in mmHg. Lower values are better.

Full Information

First Posted
October 18, 2009
Last Updated
February 15, 2018
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00999713
Brief Title
CALIPSO: Calfactant for Acute Lung Injury in Pediatric Stem Cell Transplant and Oncology Patients
Acronym
CALIPSO
Official Title
A Phase 3 Trial of Calfactant for ALI in Pediatric Leukemia and HSCT Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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 Office of Orphan Products Development (OOPD)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury
Keywords
Acute Lung Injury, Cancer, Pediatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calfactant
Arm Type
Experimental
Arm Description
Endotracheal calfactant administration
Arm Title
Placebo (air)
Arm Type
Placebo Comparator
Arm Description
Endotracheal air administration
Intervention Type
Drug
Intervention Name(s)
Calfactant
Intervention Description
Endotracheal calfactant, up to 3 doses if subject qualifies
Intervention Type
Other
Intervention Name(s)
Air placebo
Intervention Description
Endotracheal air administration
Primary Outcome Measure Information:
Title
All-cause Mortality at the Time of Pediatric Intensive Care Unit (PICU) Discharge
Description
Overall mortality rate from admission to PICU discharge
Time Frame
Admission to PICU discharge, up to 120 days
Secondary Outcome Measure Information:
Title
Ventilator Free Days (VFDs)
Description
Number of days the patient is alive and off of the ventilator
Time Frame
60 days after study enrollment
Title
Total Duration of Stay Required
Description
Length of stay (LOS) ,measured in days, from admission to PICU discharge and admission to hospital discharge.
Time Frame
Admission to discharge, up to 120 days
Title
Change in Oxygenation: First Intervention
Description
The Oxygenation Index after the first intervention is calculated as the fraction of inspired oxygen, in percent, times the mean airway pressure, in mmHg, divided by the partial pressure of oxygen in arterial blood, in mmHg. Lower values are better.
Time Frame
48 hours after enrollment, up to 12 hours after each intervention
Title
Change in Oxygenation: Second Intervention
Description
The Oxygenation Index after the second intervention (if applicable) is calculated as the fraction of inspired oxygen, in percent, times the mean airway pressure, in mmHg, divided by the partial pressure of oxygen in arterial blood, in mmHg. Lower values are better.
Time Frame
48 hours after enrollment, up to 12 hours after each intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal J Thomas, MD, MSc
Organizational Affiliation
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert F Tamburro, MD, MSc
Organizational Affiliation
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Children's Hospital of Los Angeles
City
Los Angeles
State/Province
California
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
Country
United States
Facility Name
Riley Children's Hospital
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
Country
United States
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
Maria Fareri Children's Hospital
City
Valhalla
State/Province
New York
Country
United States
Facility Name
Rainbow Babies Hospital
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17078
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
Country
United States
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
Hospital Sainte Justine
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
18679142
Citation
Tamburro RF, Thomas NJ, Pon S, Jacobs BR, Dicarlo JV, Markovitz BP, Jefferson LS, Willson DF; Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Post hoc analysis of calfactant use in immunocompromised children with acute lung injury: Impact and feasibility of further clinical trials. Pediatr Crit Care Med. 2008 Sep;9(5):459-64. doi: 10.1097/PCC.0b013e3181849bec.
Results Reference
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PubMed Identifier
15671432
Citation
Willson DF, Thomas NJ, Markovitz BP, Bauman LA, DiCarlo JV, Pon S, Jacobs BR, Jefferson LS, Conaway MR, Egan EA; Pediatric Acute Lung Injury and Sepsis Investigators. Effect of exogenous surfactant (calfactant) in pediatric acute lung injury: a randomized controlled trial. JAMA. 2005 Jan 26;293(4):470-6. doi: 10.1001/jama.293.4.470. Erratum In: JAMA. 2005 Aug 24;294(8):900.
Results Reference
background

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

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