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Completed

NCT Number: NCT03319836

Meeting Protein Targets in Critically Ill Patients

This is a retrospective study of protein and energy intake in enterally fed critically ill adult patients before and after the introduction of a very high protein enteral nutrition formula in a single center medical/surgical ICU.

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Key information

Conditions

Critical Illness Dietary Modification Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamilton Health Sciences

Hamilton, Ontario, L8L 8E7, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients ≥ 18 years of age, mechanically ventilated
  • Received enteral nutrition for a minimum of five days during the first week of ICU admission

Exclusion criteria

  • Received parenteral nutrition during first week of ICU admission
  • Acute renal failure not dialyzed
  • Hepatic encephalopathy grade 3 or 4
  • Intentional underfeeding/trophic feeding - including refeeding syndrome

Treatment and study plan

Primary outcomes

  1. Daily total protein intake

    Time frame: Daily up to 7 days of ICU stay

    Daily total protein intake and percent prescribed protein needs met during first week of ICU admission.

Secondary outcomes

  1. Daily caloric intake - Total Calories

    Time frame: Daily up to 7 days of ICU stay

    Total calories aggregate from all sources

  2. Daily caloric intake - kcal/kg

    Time frame: Daily up to 7 days of ICU stay

    Total volume consumed and weight will be used to measure kcal/kg

  3. Daily caloric intake from enteral nutrition

    Time frame: Daily up to 7 days of ICU stay

    Daily caloric intake from enteral nutrition, and medications (i.e. Propofol)

  4. Percentage of prescribed calorie needs met

    Time frame: Daily up to 7 days of ICU stay

    Percentage of prescribed calorie needs met

  5. Feeding interruptions

    Time frame: Daily up to 7 days of ICU stay

    Feeding interruptions; and reason for interruption, if recorded in electronic medical record/nursing flow sheets

  6. Use of inotropes/vasopressors (highest daily dose prescribed)

    Time frame: Daily up to 7 days of ICU stay

    Use of inotropes/vasopressors will be documented as a Yes/No.

  7. Feeding tolerance

    Time frame: Daily up to 7 days of ICU stay

    Feeding tolerance as recorded by clinicians in electronic medical record/nursing flow sheets [gastrointestinal side effects observed and documented: vomiting, elevated Gastric Residual Volumes (>200 mL), aspiration, pneumonia, diarrhea (Bristol stool chart definition and ≥ 3 liquid stools/day)]

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

  • Hamilton Health Sciences Corporation

Registry information

Official study title

Meeting Protein Targets in Critically Ill Patients: A Retrospective Analysis

Acronym: PROTARGET

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 24, 2017
Registry last updated
Sep 25, 2018

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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