Clinical trial NCT04005300: Application of Prophylactic Low Calorie Feeding in Critically Ill Patients With High-risk Refeeding Syndrome
Official title: Application of Prophylactic Low Calorie Feeding in Critically Ill Patients With High-risk Refeeding Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Illness
Keywords: Refeeding syndrome
Enteral nutrition
Critical illness
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Critically ill patients with high-risk nutrition are often at risk of refeeding syndrome(RFS), that the incidence of RFS is as high as 30-50%. It is sure that patients with refeeding syndrome were treated with restrictive enteral nutrition, but the definition of refeeding syndrome is not uniform, and there is still a lack of awareness high-risk patients of RFS to receiving early empirical low-calorie feeding intervention. So, we designed the study which is divided into three stages. Firstly, the monitoring rate of RFS was reviewed to evaluate the incidence of RFS in general ICU. Secondly, the best diagnostic criteria of RFS were prospectively defined. Finally, on this basis, it is assessed whether early low-calorie feeding could improve prognosis in high-risk patients with RFS.

Detailed description: Stage 1: the monitoring rate of re-feeding syndrome in our department was reviewed to evaluate the incidence of re-feeding syndrome in severe patients,which is not described in detail; Stage 2:This part is a prospective observational study，divided into two group,that is, RFS group(their serum phosphate concentration decreased to below 0.87 mmol/L within 72 h after starting nutritional support and the biological variation needed to be greater than 30% decrease from any concentration previously recorded), which is divided into three sub-group(Group 1 that a drop of \>0.16 mmol/L from any previous measurement, to below 0.65 mmol/L within 72 h after starting nutritional support, Group 2 that their serum phosphate concentration decreased to below 0.87 mmol/L within 72 h after starting nutritional support and the biological variation needed to be greater than 30% decrease from any concentration previously recorded, and Group 3 that their serum phosphate concentration decreased to below 0•32 mmol/L within 72 h after starting nutritional support.), and nRFS group(non-RFS that the serum phosphate do not up to the criteria). And the RFS group will be receiving the low-calorie feeding intervention, the nRFS group will be receiving the standard feeding according to the ASPEN guideline of 2016.

Stage 3: On this basis of stage 2, it is assessed whether early low-calorie feeding could improve prognosis in high-risk patients with RFS who was defined in NICE(National institute for the health and care excellence).The part of stage 3, divided into two groups that standard calorie feeding group and low calorie feeding group, aims to assess whether early low-calorie feeding could improve prognosis in high-risk patients with RFS.

Eligibility criteria: Inclusion Criteria:

* Critically ill patients at least 18 years old;
* No history of enteral nutrition or parenteral nutrition within 1 week before ICU admission or ICU admission within 1 week;
* Mechanical ventilation patients requiring enteral nutrition support for \>72h

Exclusion Criteria:

* refuse to join this study;
* enteral nutrition support for less than 3 days or have enteral nutrition contraindication;
* less than 18 years old;
* artificial nutrition (enteral/parenteral nutrition) has been applied to patients before admission;
* other factors of hypophosphatemia: continuous hemodialysis, recent parathyroidectomy, or hyperphosphatemia after treatment;

Primary outcomes:
measure: The best diagnostic criteria for refeeding syndrome
timeFrame: 1 month mortality and the duration of mechanical ventilation
measure: the incidence of refeeding syndrome
timeFrame: 3 day after treated with nutrition
Secondary outcomes:
measure: duration of mechanical ventilation
timeFrame: 30 days
measure: survival rate
timeFrame: 28 days
measure: occurrence of complications
timeFrame: 7 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second affiliated hospital, Zhejiang university school of medicine
state: Zhejiang
Study officials:
affiliation: Second affiliated hospital, Zhejiang university school of medicine
name: man huang, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: Second affiliated hospital, Zhejiang university school of medicine
name: yunlong wu, master
role: STUDY_DIRECTOR
References:
citation: Doig GS, Simpson F, Heighes PT, Bellomo R, Chesher D, Caterson ID, Reade MC, Harrigan PW; Refeeding Syndrome Trial Investigators Group. Restricted versus continued standard caloric intake during the management of refeeding syndrome in critically ill adults: a randomised, parallel-group, multicentre, single-blind controlled trial. Lancet Respir Med. 2015 Dec;3(12):943-52. doi: 10.1016/S2213-2600(15)00418-X. Epub 2015 Nov 18.
citation: Rio A, Whelan K, Goff L, Reidlinger DP, Smeeton N. Occurrence of refeeding syndrome in adults started on artificial nutrition support: prospective cohort study. BMJ Open. 2013 Jan 11;3(1):e002173. doi: 10.1136/bmjopen-2012-002173.