Critical IllnessNCT04005300
Application of Prophylactic Low Calorie Feeding in Critically Ill Patients With High-risk Refeeding Syndrome
A study testing standard enteral nutrition and restricted enteral nutrition in people with Critical Illness, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- standard enteral nutrition and restricted enteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
man huang, phD contact
China1 site, 1 recruiting
- Recruiting
Second affiliated hospital, Zhejiang university school of medicine
Hangzhou, Zhejiang, 310052
lu kongmiao, master, 018268061252, lukongmiao123@163.com
lu kongmiao
About this study
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.
Read the 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.
- Conditions
- Critical Illness
- Being tested
- standard enteral nutrition, restricted enteral nutrition
- Keywords
- Refeeding syndrome, Enteral nutrition, Critical illness
- Medical subject headings
- Critical Illness, Refeeding Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard enteral nutritionDietary supplement
Enteral nutrition was treated within 48 hours after ICU and the calories were 500-750kcal/d
restricted enteral nutritionDietary supplement
Enteral nutrition was treated within 48 hours after ICU and the calories were 10-20kcal/kg/d for 3 days
| Study group | Role | What they receive |
|---|---|---|
| low calorie feeding group | Experimental | Enteral nutrition was fed at 10-20kcal/kg/d for the first three days before identifying the refeeding syndrome Receives: Dietary Supplement: restricted enteral nutrition |
| standard calorie feeding group | Active comparator | Enteral nutrition was fed at 500-750kcal/d for the first three days before identifying the refeeding syndrome Receives: Dietary Supplement: standard enteral nutrition |
| RFS group | No intervention | 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. |
| nRFS group | No intervention | It is not up to the RFS definition |
What is being measured
The primary outcome is the main question the study is designed to answer.
The best diagnostic criteria for refeeding syndrome
Evaluate the best timing for intervention according to the lowest and the decline of serum phosphate
Measured: 1 month mortality and the duration of mechanical ventilation
the incidence of refeeding syndrome
only according to serum phosphate standard
Measured: 3 day after treated with nutrition
Secondary outcomes (3)
duration of mechanical ventilation
The duration of mechanical ventilation in General ICU of our department in the same time admitted to ICU
Measured: 30 days
survival rate
including discharge from hospital and ICU
Measured: 28 days
occurrence of complications
including feeding intolerance, electrolyte disturbance
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start1 Jul 2019
- Primary completion1 Aug 2020
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- man huang, phD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicineyunlong wu, master, Study director, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005300
- Sponsor's protocol ID
- refeeding syndrome
- Status last verified
- Dec 2020
- First submitted
- 1 Jul 2019
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: One year after the article was published, and the opening lasted for one year
Publications
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.
PubMed 26597128Rio 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.
PubMed 23315514
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Prophylactic Low Calorie Feeding in Critically Ill Patients With High-risk Refeeding Syndrome
- ClinicalTrials.gov ID
- NCT04005300
- Acronym / sponsor ID
- refeeding syndrome
- Conditions
- Critical Illness
- Keywords
- Refeeding syndrome, Enteral nutrition, Critical illness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| low calorie feeding group | Experimental | Dietary Supplement: restricted enteral nutritionEnteral nutrition was fed at 10-20kcal/kg/d for the first three days before identifying the refeeding syndrome |
| standard calorie feeding group | Active comparator | Dietary Supplement: standard enteral nutritionEnteral nutrition was fed at 500-750kcal/d for the first three days before identifying the refeeding syndrome |
| RFS group | No intervention | –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. |
| nRFS group | No intervention | –It is not up to the RFS definition |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard enteral nutritionEnteral nutrition was treated within 48 hours after ICU and the calories were 500-750kcal/d | Dietary supplement | standard calorie feeding group |
| restricted enteral nutritionEnteral nutrition was treated within 48 hours after ICU and the calories were 10-20kcal/kg/d for 3 days | Dietary supplement | low calorie feeding group |
Primary outcome
The best diagnostic criteria for refeeding syndrome
Time frame: 1 month mortality and the duration of mechanical ventilation
Evaluate the best timing for intervention according to the lowest and the decline of serum phosphate
the incidence of refeeding syndrome
Time frame: 3 day after treated with nutrition
only according to serum phosphate standard
3 secondary outcomes
duration of mechanical ventilation
Time frame: 30 days
survival rate
Time frame: 28 days
occurrence of complications
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Background: PubMed 26597128Doig 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.
- Background: PubMed 23315514Rio 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.
- Restricted versus continued standard caloric intake during the management of refeeding syndrome in critically ill adultsLink provided by the sponsor.
- Occurrence of refeeding syndrome in adults started on artificial nutrition supportLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. One year after the article was published, and the opening lasted for one year
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
man huang, phD contact
man huang, phD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
yunlong wu, master study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard enteral nutrition and restricted enteral nutrition in people with Critical Illness, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact kongmiao lu, master (18268061252, lukongmiao123@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The best diagnostic criteria for refeeding syndrome (time frame: 1 month mortality and the duration of mechanical ventilation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04005300, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.