Trial Outcomes & Findings for Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age (NCT NCT03563222)
NCT ID: NCT03563222
Last Updated: 2022-12-12
Results Overview
Body weight of patients (patients \< 36 months of age)
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
1 participants
Primary outcome timeframe
from day 1 monthly to day 365
Results posted on
2022-12-12
Participant Flow
Participant milestones
| Measure |
Smoflipid
Smoflipid is a sterile, nonpyrogenic, white, homogenous lipid emulsion for intravenous infusion. The lipid content of Smoflipid is 0.20 g/mL, and comprises a mixture of soybean oil, medium chain triglycerides, olive oil, and fish oil. Smoflipid is indicated as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
The mean essential fatty acid content of Smoflipid is 35 mg/mL linoleic acid (omega-6) and 4.5 mg/mL α-linolenic acid (omega-3).
Smoflipid: The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter.
The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour.
The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid.
Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy.
|
Intralipid, 20%
Intralipid 20% is a sterile, non-pyrogenic fat emulsion intended as a source of calories and essential fatty acids. Intralipid 20% is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time and as a source of essential fatty acids for prevention of essential fatty acid deficiency. The major component fatty acids are linoleic acid, oleic acid, palmitic acid, α-linolenic acid and stearic acid.
Intralipid, 20%: The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter.
The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour.
The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid.
Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age
Baseline characteristics by cohort
| Measure |
Smoflipid
n=1 Participants
Smoflipid is a sterile, nonpyrogenic, white, homogenous lipid emulsion for intravenous infusion. The lipid content of Smoflipid is 0.20 g/mL, and comprises a mixture of soybean oil, medium chain triglycerides, olive oil, and fish oil. Smoflipid is indicated as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
The mean essential fatty acid content of Smoflipid is 35 mg/mL linoleic acid (omega-6) and 4.5 mg/mL α-linolenic acid (omega-3).
Smoflipid: The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter.
The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour.
The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid.
Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy.
|
Intralipid, 20%
Intralipid 20% is a sterile, non-pyrogenic fat emulsion intended as a source of calories and essential fatty acids. Intralipid 20% is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time and as a source of essential fatty acids for prevention of essential fatty acid deficiency. The major component fatty acids are linoleic acid, oleic acid, palmitic acid, α-linolenic acid and stearic acid.
Intralipid, 20%: The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter.
The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour.
The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid.
Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4 years
n=5 Participants
|
—
|
4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Body mass index
|
16.34 kg/m²
n=5 Participants
|
—
|
16.34 kg/m²
n=5 Participants
|
PRIMARY outcome
Timeframe: from day 1 monthly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Body weight of patients (patients \< 36 months of age)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 monthly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Height oder length of body (patients \<36 months of age)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 monthly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Circumference of head in patients \> 36 months old
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 monthly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Fatty acid profile including linoleic acid, α-linolenic acid, arachidonic acid, docosahexaenoic acid, eicosapentaenoic acid and Mead acid, analyzed in total plasma
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 monthly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Fatty acid profile including linoleic acid, α-linolenic acid, arachidonic acid, docosahexaenoic acid, eicosapentaenoic acid and Mead acid, analyzed in red blood cell membranes
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 weekly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Triene/tetraene ratio (Holman Index) in total plasma to assess essential fatty acid deficiency (EFAD)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 monthly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 monthly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 monthly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 weekly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 weekly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 weekly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 weekly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 weekly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 weekly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 weekly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 weekly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 weekly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 weekly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 weekly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 weekly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 weekly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 weekly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 weekly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 weekly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 weekly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 weekly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 weekly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 weekly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 monthly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 monthly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Systolic and diastolic blood pressure
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 monthly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 monthly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from day 1 weekly to day 365Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: once during treatment phase (day 1 to day 365)Population: Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality.
The relation between genetic polymorphisms in the fatty acid desaturase genes Fatty acid desaturase 1 (FADS1) and Fatty acid desaturase 2 (FADS2) and plasma concentrations of linoleic acid, α-linolenic acid, arachidonic acid, docosahexaenoic acid, eicosapentaenoic acid, and Mead acid, as well as relation to and EFAD (triene/tetraene ratio)
Outcome measures
Outcome data not reported
Adverse Events
Smoflipid
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Intralipid, 20%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Smoflipid
n=1 participants at risk
Smoflipid is a sterile, nonpyrogenic, white, homogenous lipid emulsion for intravenous infusion. The lipid content of Smoflipid is 0.20 g/mL, and comprises a mixture of soybean oil, medium chain triglycerides, olive oil, and fish oil. Smoflipid is indicated as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
The mean essential fatty acid content of Smoflipid is 35 mg/mL linoleic acid (omega-6) and 4.5 mg/mL α-linolenic acid (omega-3).
Smoflipid: The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter.
The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour.
The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid.
Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy.
|
Intralipid, 20%
Intralipid 20% is a sterile, non-pyrogenic fat emulsion intended as a source of calories and essential fatty acids. Intralipid 20% is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time and as a source of essential fatty acids for prevention of essential fatty acid deficiency. The major component fatty acids are linoleic acid, oleic acid, palmitic acid, α-linolenic acid and stearic acid.
Intralipid, 20%: The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter.
The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour.
The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid.
Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy.
|
|---|---|---|
|
Infections and infestations
BACTERAEMIA
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Vascular disorders
HYPOVOLAEMIC SHOCK
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Gastrointestinal disorders
FUNCTIONAL GASTROINTESTINAL DISORDER
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Infections and infestations
GASTROENTERITIS
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
General disorders
PYREXIA
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Infections and infestations
DEVICE RELATED SEPSIS
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
Other adverse events
| Measure |
Smoflipid
n=1 participants at risk
Smoflipid is a sterile, nonpyrogenic, white, homogenous lipid emulsion for intravenous infusion. The lipid content of Smoflipid is 0.20 g/mL, and comprises a mixture of soybean oil, medium chain triglycerides, olive oil, and fish oil. Smoflipid is indicated as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
The mean essential fatty acid content of Smoflipid is 35 mg/mL linoleic acid (omega-6) and 4.5 mg/mL α-linolenic acid (omega-3).
Smoflipid: The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter.
The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour.
The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid.
Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy.
|
Intralipid, 20%
Intralipid 20% is a sterile, non-pyrogenic fat emulsion intended as a source of calories and essential fatty acids. Intralipid 20% is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time and as a source of essential fatty acids for prevention of essential fatty acid deficiency. The major component fatty acids are linoleic acid, oleic acid, palmitic acid, α-linolenic acid and stearic acid.
Intralipid, 20%: The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter.
The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour.
The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid.
Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Cardiac disorders
TACHYCARDIA
|
100.0%
1/1 • Number of events 3 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Gastrointestinal disorders
VOMITING
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
General disorders
PYREXIA
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Investigations
LIPASE INCREASED
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Investigations
WEIGHT DECREASED
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
100.0%
1/1 • Number of events 4 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
100.0%
1/1 • Number of events 2 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
100.0%
1/1 • Number of events 2 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
100.0%
1/1 • Number of events 2 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
100.0%
1/1 • Number of events 2 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Metabolism and nutrition disorders
TETANY
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
|
Vascular disorders
HYPOTENSION
|
100.0%
1/1 • Number of events 1 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
—
0/0 • Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60