MedDataX Logo

Application of Prophylactic Low Calorie Feeding in Critically Ill Patients With High-risk Refeeding Syndrome

NCT ID: NCT04005300

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2021-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Critical Illness

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Refeeding syndrome Enteral nutrition Critical illness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

low calorie feeding group

Enteral nutrition was fed at 10-20kcal/kg/d for the first three days before identifying the refeeding syndrome

Group Type EXPERIMENTAL

restricted enteral nutrition

Intervention Type DIETARY_SUPPLEMENT

Enteral nutrition was treated within 48 hours after ICU and the calories were 10-20kcal/kg/d for 3 days

standard calorie feeding group

Enteral nutrition was fed at 500-750kcal/d for the first three days before identifying the refeeding syndrome

Group Type ACTIVE_COMPARATOR

standard enteral nutrition

Intervention Type DIETARY_SUPPLEMENT

Enteral nutrition was treated within 48 hours after ICU and the calories were 500-750kcal/d

RFS group

The definition of RFS is that 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 it is divided into three sub-group that is 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

nRFS group

It is not up to the RFS definition

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

standard enteral nutrition

Enteral nutrition was treated within 48 hours after ICU and the calories were 500-750kcal/d

Intervention Type DIETARY_SUPPLEMENT

restricted enteral nutrition

Enteral nutrition was treated within 48 hours after ICU and the calories were 10-20kcal/kg/d for 3 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

man huang, phD

Role: PRINCIPAL_INVESTIGATOR

Second affiliated hospital, Zhejiang university school of medicine

yunlong wu, master

Role: STUDY_DIRECTOR

Second affiliated hospital, Zhejiang university school of medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Second affiliated hospital, Zhejiang university school of medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

kongmiao lu, master

Role: CONTACT

Phone: 18268061252

Email: [email protected]

man huang, phD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

lu kongmiao, master

Role: primary

lu kongmiao

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26597128 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23315514 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://linkinghub.elsevier.com/retrieve/pii/S2213-2600(15)00418-X

Restricted versus continued standard caloric intake during the management of refeeding syndrome in critically ill adults

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3549252/

Occurrence of refeeding syndrome in adults started on artificial nutrition support

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

refeeding syndrome

Identifier Type: -

Identifier Source: org_study_id