Status:
UNKNOWN
Can SMOFlipid®, A Composite Parenteral Nutrition Lipid Emulsion, Prevent Progression Of Parenteral Nutrition Associated Liver Disease In Infants?
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Fresenius Kabi
Conditions:
Short Bowel Syndrome
Intestinal Failure
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE2
Brief Summary
The aim of this study is to determine the feasibility of conducting a trial to examine the efficacy of an ω3FA (Omega-3 fatty acid) containing balanced lipid emulsion in the prevention of progression ...
Detailed Description
Parenteral nutrition (PN) associated liver disease (PNALD), remains the primary cause of morbidity and mortality in infants with Short Bowel Syndrome (SBS) and intestinal failure. Although, the etiolo...
Eligibility Criteria
Inclusion
- ≤ 24 months of age at enrollment
- Evidence of early hepatic dysfunction
- Serum conjugated bilirubin ≥ 17 umol/L on 2 consecutive readings 7 days apart
- No evidence of sepsis
- Normal Temperature (T between 35.5C and 38.0C)
- Normal leukocyte count
- Normal platelet count
- No systemic septic symptoms
- No prior administration of Omegaven
- ≥ 40% of total calories administered by PN
- Meet one of the following diagnostic categories
- Short Bowel Syndrome
- Abdominal surgical procedure including gastroschisis closure by any means and percutaneous drainage procedures within the past 6 months and has been receiving PN since surgery
- Intestinal Failure
- One of the following diagnoses for which the child is dependent on PN
- Gastrointestinal Motility Disorder
- Mucosal Enteropathy
- Expectation of the treating physician that the patient will require PN for at least 3 weeks following enrollment.
- Parents willing to participate including randomization
Exclusion
- Sepsis or Hemodynamic Instability of any cause.
- Coagulopathy (Platelets ≤ 150 000, or INR ≥ 1.4)
- Hypersensitivity to fish-, egg- or soy protein or to any of the active substances or excipients
- Current enrollment in another clinical trial involving a surgical or pharmacologic intervention
- Serum conjugated bilirubin \> 50 umol/L
- Hyperlipidaemia (any of)
- LDL ≥ 4 mmol/L
- HDL ≥ 2 mmol/L
- Total cholesterol ≥ 5 mmol/L
- Triglycerides ≥ 1.5 mmol/L
- Treatment with intravenous N-Acetylcysteine or Ursodeoxycholic acid
- Renal insufficiency
- Creatinine ≥ 80 umol/L
- Disorders of Fluid Balance (any of)
- Serum Sodium \< 130 mmol/L
- Serum Sodium \> 145 mmol/L
- Unstable conditions
- Acute pulmonary edema
- Decompensated cardiac insufficiency
- Severe post-traumatic conditions
- Uncompensated diabetes mellitus
- Acute myocardial infarction
- Stroke within 3 months
- Thromboembolic event within 3 months
- Metabolic acidosis
- Serum Bicarbonate \< 17 mmol/L
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00793195
Start Date
January 1 2009
End Date
January 1 2012
Last Update
November 3 2011
Active Locations (5)
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1
Alberta Children's Hospital
Calgary, Alberta, Canada
2
Foothills Medical Center
Calgary, Alberta, Canada
3
Stollery Children's Hospital
Edmonton, Alberta, Canada
4
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5