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

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.

Study Overview

• Status: Completed
• Conditions: Development and Validation of a Prediction Model for Refeeding Syndrome in ICU Patients Undergoing Enteral Nutrition

• Study Type: Observational
• Enrollment (Actual): 553

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hanzhou, Zhejiang, China, 310000
      • Development and Validation of a Prediction Model for Refeeding Syndrome in ICU Patients Undergoing Enteral Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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 .

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
RFS
non-RFS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	from December 1, 2019 to October 31, 2020

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Refeeding Syndrome;Enteral Nutrition;Prediction;Intensive Care
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Nutrition Disorders; Malnutrition; Syndrome; Refeeding Syndrome
• Other Study ID Numbers: 2020-394

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No