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Comparing High-protein Vs. Standard Protein Nutritional Support in Critically Ill Patients At Risk for Refeeding Syndrome

NCT06825377 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-02-14

No results posted yet for this study

Summary

The goal of this clinical trial is to determine the optimal protein administration strategy for enhancing both nutritional and clinical outcomes, as well as reducing complications and mortality in ICU patients at risk for refeeding syndrome (RS). This study will include critically ill patients at risk for RS who are receiving supportive nutrition. The primary hypothesis is that higher protein intake will lead to a decreased incidence of refeeding syndrome. It is also expected that patients receiving more protein will have better clinical outcomes, lower mortality, and shorter ICU and hospital stays.

Conditions

  • Critical Illness
  • Malnutrition
  • Refeeding Syndrome
  • At Risk for Refeeding Syndrome

Interventions

DIETARY_SUPPLEMENT

Whey protein

Whey protein powder will be provided with nutritional support in both groups if needed to meet the target protein intake.

Sponsors & Collaborators

  • Shahid Beheshti University

    lead OTHER

Principal Investigators

  • Zahra Vahdat Shariatpanahi Professor · School of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-13
Primary Completion
2026-02-15
Completion
2026-04-15

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06825377 on ClinicalTrials.gov