High Protein Intake in Critically Ill Ventilated Patients

NCT04977440 | Completed

• 1 other identifier: MS 29-2020
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Intensive Care Unit Syndrome

Outcome Measures

Primary Outcomes (2)

• Effect of high protein intake on glycemic control

  measurements of blood glucose levels regularly after high protein intake

  up to 7 days

• 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 Outcomes (1)

• Effect of high protein intake on ICU outcome

  up to 7 days

Study Arms (2)

standard protein

high protein

Dietary Supplement: Whey protein

Interventions

Whey protein DIETARY_SUPPLEMENT

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

high protein

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult mechanically ventilated patients

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Hospitals

Cairo, 11345, Egypt

Location

MeSH Terms

Interventions

Whey Proteins

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

• farouk faris, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 27, 2021
• Study Start: January 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: February 1, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

EG (1)