- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00793195
Can SMOFlipid®, A Composite Parenteral Nutrition Lipid Emulsion, Prevent Progression Of Parenteral Nutrition Associated Liver Disease In Infants?
Can SMOFlipid®, A Composite Parenteral Nutrition Lipid Emulsion, Prevent Progression Of Parenteral Nutrition Associated Liver Disease In Infants? A Pilot Double Blind Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada
- Alberta Children's Hospital
-
Calgary, Alberta, Canada
- Foothills Medical Center
-
Edmonton, Alberta, Canada
- Stollery Children's Hospital
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 3Z5
- Hamilton Health Sciences
-
Toronto, Ontario, Canada
- The Hospital for Sick Children
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ≤ 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 1) Intralipid
Fat Emulsions for Intravenous Nutrition
|
Dosing will be formulated according to a Nomogram for Parenteral Nutrition (PN) composition, which takes into account the percentage of the subject's caloric intake consumed parenterally.
PN solution will be infused continuously over 12-24 hours by infusion pump, and the duration each day will depend on the enteral tolerance of the child.
PN shall not be discontinued, unless the patient is taking 95% of calories enterally with good growth as evidence by appropriate weight gain.
Subjects will receive the trial lipid for a total duration of 12 weeks or if they develop a serum conjugated bilirubin (sustained for 7 days) of 100 umol/l (6mg/dl) or full enteral tolerance prior to this end-point.
Once the trial lipid is discontinued, in the event that PN is continued, subjects will return to the standard lipid preparation.
A final follow-up data-point will be collected 4 weeks after the trial lipid is stopped.
|
EXPERIMENTAL: 2) SMOFlipid
Fat Emulsions for Intravenous Nutrition
|
Dosing will be formulated according to a Nomogram for Parenteral Nutrition (PN) composition, which takes into account the percentage of the subject's caloric intake consumed parenterally.
PN solution will be infused continuously over 12-24 hours by infusion pump, and the duration each day will depend on the enteral tolerance of the child.
PN shall not be discontinued, unless the patient is taking 95% of calories enterally with good growth as evidence by appropriate weight gain.
Subjects will receive the trial lipid for a total duration of 12 weeks or if they develop a serum conjugated bilirubin (sustained for 7 days) of 100 umol/l (6mg/dl) or full enteral tolerance prior to this end-point.
Once the trial lipid is discontinued, in the event that PN is continued, subjects will return to the standard lipid preparation.
A final follow-up data-point will be collected 4 weeks after the trial lipid is stopped.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean serum conjugated bilirubin (umol/L)
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion with the development of cholestasis (sustained serum conjugated bilirubin >50 umol/L for greater than 2 weeks in absence of sepsis)
Time Frame: 12 and 16 weeks
|
12 and 16 weeks
|
Proportion with progression of liver disease (sustained serum conjugated bilirubin >100 umol/L in absence of sepsis)
Time Frame: 12 and 16 weeks
|
12 and 16 weeks
|
Degree of enteral tolerance (%)
Time Frame: 12 and 16 weeks
|
12 and 16 weeks
|
Growth parameters
Time Frame: 12 and 16 weeks
|
12 and 16 weeks
|
Biochemical outcomes shall assess mean levels of "hepatic markers" (AST, ALT, ALP, GGT), coagulation parameters (PT, PTT, INR, platelets), serum lipid levels (triglycerides and cholesterol), serum albumin, and Nephelometry (lipid clearance).
Time Frame: 12 and 16 weeks
|
12 and 16 weeks
|
Immunologic outcomes shall include assessment of RBC phospholipids composition, C-reactive Protein (CRP) and serum immunologic marker (IL-1b, IL-2R, IL-6, IL-8, IL-10, TNF-α) assessment
Time Frame: 12 and 16 weeks
|
12 and 16 weeks
|
Feasibility of trial (recruitment, protocol adherence, estimated effect size
Time Frame: 4, 12 and 16 weeks
|
4, 12 and 16 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul Wales, The Hospital for Sick Children
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Postoperative Complications
- Gastrointestinal Diseases
- Intestinal Diseases
- Malabsorption Syndromes
- Liver Diseases
- Short Bowel Syndrome
- Pharmaceutical Solutions
- Parenteral Nutrition Solutions
- Fat Emulsions, Intravenous
- Soybean oil, phospholipid emulsion
- SMOFlipid
Other Study ID Numbers
- 1000012566
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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