Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01847534 | Supplemental Parenteral Nutrition in Critically Ill Adults: A Pilot Randomised Controlled Trial | PHASE2 | COMPLETED | 100 | — | — | Feb 1, 2014 | Jul 1, 2016 | Aug 2, 2016 | 6 | Australia, New Zealand |
The primary outcome for this pilot study is the total energy amount delivered from nutrition therapy (ie. from Enteral Nutrition (EN) and from supplemental PN, if delivered) over the first 7 days of the study period.
| Arm | Type | Description |
|---|---|---|
| Standard Care | OTHER | Standard care: Nutrition will be managed as per best practice and local policy including the use of small bowel feeding tubes, prokinetics and PN if required to meet nutrition needs. |
| Supplemental PN | EXPERIMENTAL | Supplemental PN to complete inadequate EN provision 1. Patients allocated to the supplemental PN (intervention) group will have PN commenced within 2 hours of randomisation. The starting dose of PN will be determined by the amount of energy received in the 24 hours prior to randomisation. 2. EN will be managed as per local protocol however EN must not be reduced based on the supplemental PN being administered. 3. The adequacy of nutrition provision from both PN and EN will be assessed at midday each day for 7 days or until ICU discharge. The dose of PN will be adjusted according to a prespecified schedule. |
| Name | Type | Description |
|---|---|---|
| Supplemental PN | OTHER | - |
| Standard Care | OTHER | - |
Inclusion Criteria: Patients in intensive care who meet all of the following: * Admitted to intensive care between 48 hours and 72 hours previously * Mechanically ventilated at the time of enrollment and expected to remain ventilated until the day after tomorrow * At least 16 years of age * Have c...