High Protein Intake in Critically Ill Ventilated Patients

Completed

• Conditions: Intensive Care Unit Syndrome
• Interventions: Dietary Supplement: Whey protein

• Registration Number: NCT04977440
• Lead Sponsor: Cairo University

Brief Summary

This prospective interventional randomized control study was conducted on forty patients with respiratory failure; all patients were intubated and mechanically ventilated for at least three days. Twenty patients received high protein intake using whey protein, with daily follow-up of the blood sugar level, serum electrolytes, and chemistry. ICU outcome regarding food intolerance, 30-day mortality, length of MV and ICU-stay was recorded

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-02-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-13
• Study First Submitted QC: 2021-07-15
• Last Update Submitted: 2021-07-15
• Study First Posted: 2021-07-27
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age >18 years
• Mechanically ventilated patients (for three days or more )

Exclusion Criteria

• Age < 18 years old
• Contraindication for enteral nutrition (gut ischemia, obstruction, or perforation)
• Expected intolerance for enteral nutrition (paralytic ileus)
• Inability to start enteral nutrition within 24-hours(i.e. surgery or other interventions)
• Short bowel syndrome
• Hemodynamic instability ( i.e shock state, need for vasopressors )
• Child C liver cirrhosis or acute liver failure
• Dialysis dependency

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
high protein	Whey protein	-

Primary Outcome Measures

Name	Time	Method
Effect of high protein intake on glycemic control	up to 7 days	measurements of blood glucose levels regularly after high protein intake
Effect of high protein intake on serum electrolytes	up to 7 days	measurements of Na, K, Mg, phosphorous and calcium levels regularly after high protein intake

Secondary Outcome Measures

Name	Time	Method
Effect of high protein intake on ICU outcome	up to 7 days	ICU outcome includes ICU survival , mechanical ventilation , food intolerance

Trial Locations

Locations (1)

Cairo University Hospitals; 🇪🇬 Cairo, Egypt