| Study name |
Comparison of time‐restricted feeding and continuous feeding in critically ill patients |
| Methods |
Randomised controlled trial |
| Participants |
380 participants |
| Interventions |
Arm Intervention/treatment
continuous feeding
The total amount of every days' Enteral Nutritional Suspension was fed at constant speed for 24 hours
Other: continuous feeding
At the beginning, all enrolled patients were fed by continuous feeding. When the amount calorie of feeding enteral nutritional suspension increased to 80% target calorie (target calorie: 25kilocalorie/kg/day), the patients was randomly into continuous feeding and time‐restricted feeding group.In the continuous feeding, the total amount of every days' Enteral Nutritional Suspension was fed at constant speed for 24 hours.
Time‐restricted feeding
The total amount of every days' Enteral Nutritional Suspension was fed at constant speed for 6h (7:00‐9:00,11:00‐13:00,17:00‐19:00).
Other: time‐restricted feeding
At the beginning, all enrolled patients were fed by continuous feeding. When the amount calorie of feeding enteral nutritional suspension increased to 80% target calorie (target calorie: 25kilocalorie/kg/day), the patients was randomly into continuous feeding and time‐restricted feeding group. In continuous feeding group, the enteral nutritional suspension was fed at constant speed for 24h.In the time restricted feeding, feeding time should be at 7:00‐9:00, 11:00‐13:00 and 17:00‐19:00 at constant feeding speed. |
| Outcomes |
Primary outcome measures:
nitrogen balance [ Time Frame: at the time point of 10th feeding day ]
it equal to Nitrogen intake minus Nitrogen output.Source of nitrogen intake is the enteral nutritional suspension, and the amount of nitrogen can be calculated according to the proportion of nitrogen in enteral nutritional suspension. Main nitrogen losses include urine and faeces. The amount of nitrogen in urine and faeces can be measured by clinical laboratory.
Secondary Outcome Measures:
delirium [ Time Frame: up to 10 days ]
it is disorders of the mental state and medical condition. It can be evaluated by The Confusion Assessment Method for the Intensive Care Unit (CAM‐ICU).
Gastric residual volume [ Time Frame: up to 10 days ]
This index was to evaluate the feeding complications. Nurse can evaluate the volume by pumping the stomach tube with syringe to measure the gastric content amount.
diarrhoea [ Time Frame: up to 10 days ]
This index was to evaluate the feeding complications. It is the condition of having at least three loose or liquid bowel movements each day.
Incidence of ventilator‐associated pneumonia [ Time Frame: up to 10 days ]
This index was to evaluate the feeding complications. Ventilator‐associated pneumonia (VAP) is a type of lung infection that occurs in people who are on mechanical ventilation breathing machines for at least 48 hours. The diagnosis of VAP varies among hospitals and providers but usually requires a new infiltrate on chest x‐ray plus two or more other factors. These factors include temperature of >38 or <36 °C, a white blood cell count of >12 × 10^9/ml, purulent secretions from the airways in the lung, and/or reduction in gas exchange.
glucose fluctuation [ Time Frame: up to 10 days ]
This index was to evaluate the feeding complications. The glucose is measured at the 11:00, 15:00, 21:00, 1:00 and 5:00 five time points. The glucose fluctuation is the maximum glucose amount plus minimum glucose amount.
Albumin [ Time Frame: up to 10 days ]
Serum albumin is the main protein of human blood plasma. It can be measured by clinical laboratory. |
| Starting date |
May 9, 2018 |
| Contact information |
icuyaobo@126.com |
| Notes |
NCT03439618 |
