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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03292237 | Intensive Nutrition in Critically Ill Adults | PHASE2 | COMPLETED | 240 | — | — | Oct 15, 2018 | Jul 31, 2023 | May 24, 2024 | 23 | Australia, New Zealand |
| Arm | Type | Description |
|---|---|---|
| Standard Nutrition Arm | NO_INTERVENTION | In ICU: 1. After enrolment, patients allocated to the standard nutrition therapy (control) group will commence or continue nutrition via an enteral tube to a target rate according to unit protocol including the use of promotility agents and the placement of nasojejunal feeding tubes if required. 2. PN will only be used if the above methods have been attempted, or an absolute contraindication to EN develops. 3. Unless there is specific indication for a compounded PN solution, the PN used in the standard care group will be the same as used in the intervention arm. After ICU: 1. Nutrition management will be as per usual site management at that hospital. 2. Nutrition intake amounts will be recorded 3 times per week using provided study documents and assessment tools. |
| Intensive Arm | EXPERIMENTAL | Intervention In ICU: 1. Supplemental PN will be 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. The need for the intervention will be based on the adequacy of nutrition provision from both PN and EN and assessed daily until ICU discharge 3. If there is an actual or anticipated interruption of EN for greater than 2 hours the PN must be run at 20 kcal/kg calculated body weight until EN is recommenced. After the interruption, EN should be recommenced as per local protocol. After ICU: An intensive nutrition intervention will be provided on the ward in the intervention group. This will include daily review from dedicated study dietitians and a clearly protocolized hierarchical management plan which reflects best practice clinical management. |
| Name | Type | Description |
|---|---|---|
| Supplemental parenteral nutrition | DIETARY_SUPPLEMENT | Supplemental parenteral nutrition OLIMEL N12E (Baxter Healthcare Corporation) |
Inclusion criteria Patients in intensive care who meet all of the following will be eligible: 1. Admitted to intensive care between 72 hours and 120 hours 2. Receiving invasive ventilator support 3. At least 18 years of age 4. Have central venous access suitable for PN solution administration 5. H...