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High Protein Intake in Critically Ill Ventilated Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04977440
Enrollment
40
Registered
2021-07-27
Start date
2020-01-01
Completion date
2021-02-01
Last updated
2021-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Unit Syndrome

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

Interventions

DIETARY_SUPPLEMENTWhey 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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Effect of high protein intake on glycemic controlup to 7 daysmeasurements of blood glucose levels regularly after high protein intake
Effect of high protein intake on serum electrolytesup to 7 daysmeasurements of Na, K, Mg, phosphorous and calcium levels regularly after high protein intake

Secondary

MeasureTime frameDescription
Effect of high protein intake on ICU outcomeup to 7 daysICU outcome includes ICU survival , mechanical ventilation , food intolerance

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026