High Protein Intake in Critically Ill Ventilated Patients

Intensive Care Unit Syndrome Clinical Trial

Official title:

High Protein Intake During the Early Phase of Critical Illness Compared With Normal Protein Intake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04977440
• Other study ID #: MS 29-2020
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: July 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care Unit Syndrome

Intervention

Dietary Supplement:
• Whey protein
Patients were randomly divided into two groups: Group (A): Enteral feeding with normal protein intake ( 1.0 gm pin /kg/day ) Group (B): Enteral feeding with high protein intake ( 1.5- gm open /kg/day ) -Patient's- nonprotein- caloric intake was calculated according to REE :(25xactual body weight in kg ) and received it as follow : 1/2 the calculated amount of caloric intake in DAY 1 3/4 of the calculated amount of caloric intake in DAY 2 -Full calculated caloric amount in DAY 3 This regimen was followed long as the patient was tolerating the amount of feeding, and in case of intolerance: The volume of feeding boluses was decreased or Increase the time interval between boluses or IV metoclopramide or erythromycin was given

Locations

Country	Name	City	State
Egypt	Cairo University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of high protein intake on glycemic control	measurements of blood glucose levels regularly after high protein intake	up to 7 days
Primary	Effect of high protein intake on serum electrolytes	measurements of Na, K, Mg, phosphorous and calcium levels regularly after high protein intake	up to 7 days
Secondary	Effect of high protein intake on ICU outcome	ICU outcome includes ICU survival , mechanical ventilation , food intolerance	up to 7 days