Development and Validation of a Prediction Model for Refeeding Syndrome in ICU Patients Undergoing Enteral NutritionRFSNCT04954755
Development and Validation of a Prediction Model for Refeeding Syndrome in ICU Patients Undergoing Enteral Nutrition Patients
An observational study of Development and Validation of a Prediction Model for Refeeding Syndrome in ICU Patients Undergoing Enteral Nutrition, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study intends to strengthen the discussion on the risk factors of RFS in critically ill patients, and construct an RFS risk prediction model which is easy for clinical medical staff to use and has a high sensitivity and specificity; In order to help medical staff to identify the high-risk groups of RFS in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Development and Validation of a Prediction Model for Refeeding Syndrome in ICU Patients Undergoing Enteral Nutrition
- How many people
- 553 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 31 Oct 2020
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Modeling queue: Relevant information of 433 patients who received enteral nutrition from January 2018 to July 2020 in ICU of a tertiary hospital in Zhejiang . Authentication queue: Relevant information of 120 patients who received enteral nutrition from August 2020 to October 2020 in ICU of four tertiary hospitals in Zhejiang .
Who may be able to join
- (1) Age ≥18 years old; (2) Patients with mechanical ventilation; (3) First admission to ICU； (4) The time of receiving enteral nutrition support in ICU was ≥ 3 days.
Who cannot join
- (1)Ppregnant women or lactating patients;(2) Patients with incomplete information;(3) There are other risk factors leading to hypophosphatemia, such as continuous hemodialysis , hyperphosphatemia treatment,Parathyroid gland resection was performed within 3 months.
Trial locations and contacts
1 site in 1 country.
China1 site
Development and Validation of a Prediction Model for Refeeding Syndrome in ICU Patients Undergoing Enteral Nutrition
Hanzhou, Zhejiang, 310000
About this study
Official title: Development and Validation of a Prediction Model for Refeeding Syndrome in ICU Patients Undergoing Enteral Nutrition
This study intends to strengthen the discussion on the risk factors of RFS in critically ill patients, and construct an RFS risk prediction model which is easy for clinical medical staff to use and has a high sensitivity and specificity; In order to help medical staff to identify the high-risk groups of RFS in critically ill patients efficiently and accurately, and take targeted care and treatment for patients, so as to reduce the adverse consequences of RFS on critically ill patients.
- Keywords
- Refeeding Syndrome;Enteral Nutrition;Prediction;Intensive Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RFS | Not described | |
| non-RFS | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of RFS
Occurrence of RFS：Within 72 hours after feeding serum phosphorus < 0.0.87mmol/L, or from the baseline levels drop > 0.16% or drop > 30%;And (or) hypokalemia, hypomagnesemia, hypocalcemia and corresponding clinical symptoms.
Measured: from December 1, 2019 to October 31, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Dec 2019
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development and Validation of a Prediction Model for Refeeding Syndrome in ICU Patients Undergoing Enteral NutritionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 553 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meiqi Yao, undergraduate, Study chair, Second Affiliated Hospital, Zhejiang University, School of MedicineXingxia Long, postgraduate, Principal investigator, Huzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954755
- Sponsor's protocol ID
- 2020-394
- Acronym
- RFS
- Status last verified
- Jun 2021
- First submitted
- 6 Jul 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Prediction Model for Refeeding Syndrome in ICU Patients Undergoing Enteral Nutrition
- ClinicalTrials.gov ID
- NCT04954755
- Acronym / sponsor ID
- RFS / 2020-394
- Keywords
- Refeeding Syndrome;Enteral Nutrition;Prediction;Intensive Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 553 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 8 Jul 2021 (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.
This study intends to strengthen the discussion on the risk factors of RFS in critically ill patients, and construct an RFS risk prediction model which is easy for clinical medical staff to use and has a high sensitivity and specificity; In order to help medical staff to identify the high-risk groups of RFS in critically ill patients efficiently and accurately, and take targeted care and treatment for patients, so as to reduce the adverse consequences of RFS on critically ill patients.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFS | – | – |
| non-RFS | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Modeling queue: Relevant information of 433 patients who received enteral nutrition from January 2018 to July 2020 in ICU of a tertiary hospital in Zhejiang . Authentication queue: Relevant information of 120 patients who received enteral nutrition from August 2020 to October 2020 in ICU of four tertiary hospitals in Zhejiang .
Key inclusion criteria (1 listed)
- (1) Age ≥18 years old; (2) Patients with mechanical ventilation; (3) First admission to ICU； (4) The time of receiving enteral nutrition support in ICU was ≥ 3 days.
Key exclusion criteria (1 listed)
- (1)Ppregnant women or lactating patients;(2) Patients with incomplete information;(3) There are other risk factors leading to hypophosphatemia, such as continuous hemodialysis , hyperphosphatemia treatment,Parathyroid gland resection was performed within 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of RFS
Time frame: from December 1, 2019 to October 31, 2020
Occurrence of RFS：Within 72 hours after feeding serum phosphorus < 0.0.87mmol/L, or from the baseline levels drop > 0.16% or drop > 30%;And (or) hypokalemia, hypomagnesemia, hypocalcemia and corresponding clinical symptoms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
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.
Meiqi Yao, undergraduate study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
Xingxia Long, postgraduate principal investigator
Huzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Development and Validation of a Prediction Model for Refeeding Syndrome in ICU Patients Undergoing Enteral Nutrition, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 8 Jul 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of RFS (time frame: from December 1, 2019 to October 31, 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2021.