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

NCT06825377 | Recruiting DMC

• 1 other identifier: 450/1272
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Refeeding syndrome; Critically ill; High-protein; Complication; Malnutrition; mortality

Outcome Measures

Primary Outcomes (1)

• Number of participants with refeeding syndrome

  Refeeding syndrome will be diagnosed based on a decrease in serum levels of electrolytes, including potassium, magnesium, and phosphate, within the first 5 days of nutrition delivery.

  within the first 5-7 days of nutrition delivery

Secondary Outcomes (5)

• Incidence of infection

  Within 5-14 days of nutrition delivery

• Number of participants with organ failure as measured by SOFA score

  Within 5-14 days of nutrition delivery

• Duration of ICU stay

  up to 7 weeks after admission

• Duration of hospital stay

  up to 7 weeks after admission

• Mortality

  up to 45-day

Study Arms (2)

High-protein

EXPERIMENTAL

The target protein intake of 2 grams per kilogram of body weight per day will be gradually introduced, starting at a low level, through nutritional support, with whey protein powder added if needed as a supplement.

Dietary Supplement: Whey protein

Standard-protein

ACTIVE COMPARATOR

The target protein intake of 1.3 grams per kilogram of body weight per day will be gradually introduced, starting at a low level, through nutritional support, with whey protein powder added if needed as a supplement.

Dietary Supplement: Whey protein

Interventions

Whey protein DIETARY_SUPPLEMENT

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

High-protein; Standard-protein

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to cooperate and complete the informed consent form by the patient or legal guardian;
• age ≤ 18 years and \< 65 years;
• Non-pregnant and non-lactating;
• Serum creatinine ≥ 1.1 mg/dl for women and ≥ 1.2 mg/dl for men;
• No organ failure at the time of study enrollment;
• Intervention initiation within 48 hours of ICU admission;
• No history of metastatic cancer or end-stage disease;
• No absolute contraindications to enteral nutrition (e.g., persistent ileus, gastrointestinal ischemia, persistent or biliary vomiting, mechanical obstruction);
• No active infections, sepsis, severe sepsis, or septic shock;
• No intolerance to the whey protein supplement used in the current study;
• Not participating in other clinical trials concurrently with this study;
• No clinical conditions with higher or lower protein needs, such as burns, sepsis, cirrhosis, or chronic kidney disease;
• No diabetes with severe complications such as ketoacidosis, hyperosmolar coma, or acidosis.

You may not qualify if:

• Unwillingness to continue cooperation during study;
• Discharge or death of the patient earlier than 5 days from the start of the intervention;
• Occurrence of side effects during the study

Sponsors & Collaborators

• Shahid Beheshti University: lead

Study Sites (1)

Ayatollah Taleghani Medical, Educational, and Therapeutic Center, Shahid Beheshti University of Medical Sciences

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Critical Illness; Malnutrition; Refeeding Syndrome

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Zahra Vahdat Shariatpanahi Professor

  School of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zahra Vahdat Shariatpanahi Professor

CONTACT

0098-021-22357484; nutritiondata@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: February 13, 2025
• Study Start: February 13, 2025
• Primary Completion: February 15, 2026
• Study Completion: April 15, 2026
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

IR (1)