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NCT03017079

A More Physiological Feeding Process in ICU:the Intermittent Infusion With Semi-solidification of Nutrients

Completed NA Results posted Last updated 2 November 2021
What this trial tests

NA trial testing semi-solid agent with standard enteral feeding in Nutrition, Enteral in 40 participants. Completed in 1 March 2017.

Timeline
1 June 2016
Primary endpoint
1 March 2017
1 March 2017

Quick facts

Lead sponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment40
Start date1 June 2016
Primary completion1 March 2017
Estimated completion1 March 2017
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

Adults 14 to 90, any sex, with Nutrition, Enteral. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

the Ratio of the Enteral Nutrition Primary · 3 days after receiving enteral nutrition

the ratio of the enteral nutrition=administered volume of enteral nutrition / prescribed volume of nutrition X 100%; This ratio fluctuates between 0 and 100%, and the higher the ratio, the higher the execution rate

GroupValue95% CI
Intermittent Feeding With Semi-solid Nutrients0.98± 0.067
Standard Enteral Feeding0.73± 0.15
the Patient of Feeding Intolerance(FI) Secondary · 3 days

the definition of FI was included one of the conditions:diarrhea, vomiting, regurgitation, obvious bowel distension and GRV\>200mL. Due to the small sample size, only the number of patients who occurred was recorded.

GroupValue95% CI
Intermittent Feeding8
Intermittent Feeding With Semi-solid Nutrients2
the Patients With Lung Infection Secondary · 7 days

patient contain the following three conditions: 1.Sputum volume increased or Sputum properties change;2.CT Scan-Chest suggest that there was lung infection; 3.CRP and / or PCT increased

GroupValue95% CI
Intermittent Feeding8
Intermittent Feeding With Semi-solid Nutrients7
30-days Mortality Secondary · 30 days

dead within 30 days in ICU

The number of deaths within 30 days after ICU
GroupValue95% CI
Intermittent Feeding With Semi-solid Nutrients3
Intermittent Feeding2
The number of live after 30 days in ICU
GroupValue95% CI
Intermittent Feeding With Semi-solid Nutrients11
Intermittent Feeding12
the Glycemic Variability(GV) Secondary · 3 days

Divided into three grades:I:GV less than 4mmol/24h; II 4-6mmol/24h;III more than 6mmol/24h

1d-0h
GroupValue95% CI
Intermittent Feeding With Semi-solid Nutrients7.514± 2.2309
Intermittent Feeding8.457± 2.9456
1d-4h
GroupValue95% CI
Intermittent Feeding With Semi-solid Nutrients8.336± 2.1653
Intermittent Feeding9.700± 3.1001
1d-8h
GroupValue95% CI
Intermittent Feeding With Semi-solid Nutrients9.229± 3.2587
Intermittent Feeding9.664± 3.1023
1d-12h
GroupValue95% CI
Intermittent Feeding With Semi-solid Nutrients9.342857± 3.1353357
Intermittent Feeding8.985714± 3.2846630
1d-16h
GroupValue95% CI
Intermittent Feeding With Semi-solid Nutrients8.635714± 2.4069154
Intermittent Feeding8.992857± 3.1086639
1d-20h
GroupValue95% CI
Intermittent Feeding With Semi-solid Nutrients8.064286± 1.9727400
Intermittent Feeding8.721429± 2.5137097
2d-0h
GroupValue95% CI
Intermittent Feeding With Semi-solid Nutrients8.436± 2.2016
Intermittent Feeding8.686± 2.9493
2d-4h
GroupValue95% CI
Intermittent Feeding With Semi-solid Nutrients8.857± 2.5687
Intermittent Feeding9.450± 3.1889
Length of Hospital Stay (LOS) Secondary · 30 days

every participators stayed in hospital

GroupValue95% CI
Intermittent Feeding With Semi-solid Nutrients20.07± 25.71
Intermittent Feeding14.36± 7.59

Sponsor's own description

Malnutrition and underfeeding are major challenges in caring for critically ill patients. Continuous feeding were thought to be better tolerated by patients with the limited absorptive gut surface area or gastrointestinal dysfunction, but associated with more tube clogging and required the patient to be attached to an infusion pump for significant periods of time. Intermittent infusion resembled more physiological feeding process, which allowed greater patient mobility and might reach goal enteral calories earlier, and the latter were considered to effectively decrease the length of stay (LOS)-in-hospital and mortality. However, it also had some previous study found that intermittent infusion had more complications, such as diarrhea, regurgitation than continuous. Some study found that it was an efficient way to prevent aspiration and reflux by increasing the enteral nutrient solution viscosity and improve bolus intermittent feeding intolerance. The primary goal of this was to study whether receiving semi-solidification of nutrients could increase the percent prescribed calories received by improving the feeding intolerance, and secondary goal was to observing the effect of semi-solid nutrient to the LOS of ICU and in-hospital, lung infection, 30-days mortality and the glycemic variability (GV).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Semi-Solid Nutrients for Prevention of Enteral Tube Feeding-Related Complications in Japanese Population: A Systematic Review and Meta-Analysis.
    Kokura Y, Suzuki C, Wakabayashi H, Maeda K, et al · · 2020 · cited 11× · PMID 32516973 · DOI 10.3390/nu12061687
  2. A more physiological feeding process in ICU: Intermittent infusion with semi-solid nutrients (CONSORT-compliant).
    Lu K, Zeng F, Li Y, Chen C, et al · · 2018 · cited 5× · PMID 30200118 · DOI 10.1097/md.0000000000012173

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