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OpenTrials
Completed

NCT Number: NCT04977440

High Protein Intake in Critically Ill Ventilated Patients

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

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Key information

Conditions

Intensive Care Unit Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cairo University Hospitals

Cairo, 11345, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Effect of high protein intake on glycemic control

    Time frame: up to 7 days

    measurements of blood glucose levels regularly after high protein intake

  2. Effect of high protein intake on serum electrolytes

    Time frame: up to 7 days

    measurements of Na, K, Mg, phosphorous and calcium levels regularly after high protein intake

Secondary outcomes

  1. Effect of high protein intake on ICU outcome

    Time frame: up to 7 days

    ICU outcome includes ICU survival , mechanical ventilation , food intolerance

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jul 27, 2021
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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