RFS: Development and Validation of a Prediction Model for Refeeding Syndrome in ICU Patients Undergoing Enteral Nutrition Patients

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Completed
CT.gov ID
NCT04954755
Collaborator
(none)
553
1
11
50.2

Study Details

Study Description

Brief 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 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

Study Type:
Observational
Actual Enrollment :
553 participants
Observational Model:
Case-Control
Time Perspective:
Other
Official Title:
Development and Validation of a Prediction Model for Refeeding Syndrome in ICU Patients Undergoing Enteral Nutrition
Actual Study Start Date :
Dec 1, 2019
Actual Primary Completion Date :
Oct 31, 2020
Actual Study Completion Date :
Oct 31, 2020

Arms and Interventions

Arm Intervention/Treatment
RFS

non-RFS

Outcome Measures

Primary Outcome Measures

  1. Occurrence of RFS [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • (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.
Exclusion Criteria:
  • (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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Development and Validation of a Prediction Model for Refeeding Syndrome in ICU Patients Undergoing Enteral Nutrition Hanzhou Zhejiang China 310000

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Chair: Meiqi Yao, undergraduate, Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Principal Investigator: Xingxia Long, postgraduate, HuZhou University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT04954755
Other Study ID Numbers:
  • 2020-394
First Posted:
Jul 8, 2021
Last Update Posted:
Jul 8, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 8, 2021