The Effect of Higher Protein Dosing in Critically Ill Patients Ultrasound a Sub-study

NCT04242966 | Withdrawn Phase 3 DMC

• 1 other identifier: The EFFORT Ultrasound
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators will evaluate the effects of of higher protein/amino acid dosing (≥2.2 g/kg/d) vs usual care of protein/amino acid dosing (≤1.2 g/kg/d) over muscle mass in nutritionally high risk ill patients.

Conditions

Critical Illness; Malnutrition

Outcome Measures

Primary Outcomes (2)

• Change of Muscle mass of the quadriceps from baseline to day 10 post randomization

  Using ultrasound of quadriceps

  at baseline (within 24 hours of randomization, day 10 days post randomization (if still in hospital) and just prior to hospital discharge. In the event that hospital discharge is prior to day 10, the day 10 measure will not be done

• Change of Muscle quality of the quadriceps from baseline to day 10 post randomization

  Using ultrasound of quadriceps

  at baseline (within 24 hours of randomization, day 10 days post randomization (if still in hospital) and just prior to hospital discharge. In the event that hospital discharge is prior to day 10, the day 10 measure will not be done

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Patients will receive a usual protein/amino acid dose (≤1.2 g/kg/d)

Other: Usual Care; Other: Ultrasound measure

Higher Protein/Amino Acid Group

ACTIVE COMPARATOR

Patients will receive a higher protein/amino acid dose (≥2.2 g/kg/d).

Other: Higher Protein/Amino Acid Group; Other: Ultrasound measure

Interventions

Usual Care OTHER

Protein targets will be set using pre-ICU dry actual weight. For patients with BMI \>30, ideal body weight based on a BMI of 25 will be used. We will endorse the guidelines for energy targets set forth by ASPEN/SCCM, especially as it pertains to the obese patient.

Usual Care

Higher Protein/Amino Acid Group OTHER

Protein targets will be set using pre-ICU dry actual weight. For patients with BMI \>30, ideal body weight based on a BMI of 25 will be used. We will endorse the guidelines for energy targets set forth by ASPEN/SCCM, especially as it pertains to the obese patient.

Higher Protein/Amino Acid Group

Ultrasound measure OTHER

Patients will undergo the ultrasound measures at baseline (within 24 hours of randomization, day 10 days post randomization (if still in hospital) and just prior to hospital discharge. In the event that hospital discharge is prior to day 10, the day 10 measure will not be done.

Higher Protein/Amino Acid Group; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- ≥18 years old
• \- Nutritionally 'high-risk' (meeting one of the below criteria)
• Low (≤25) or High BMI (≥35)
• Moderate to severe malnutrition (as defined by local assessments). We will document the means by which sites are making this determination and capture the elements of the assessment (history of weight loss, history of reduced oral intake, etc.).
• Frailty (Clinical Frailty Scale 5 or more from proxy)
• Sarcopenia- (SARC-F score of 4 or more from proxy)
• From point of screening, projected duration of mechanical ventilation \>4 days
• \- Requiring mechanical ventilation with actual or expected total duration of mechanical ventilation \>48 hours

You may not qualify if:

• \>96 continuous hours of mechanical ventilation before screening
• Expected death or withdrawal of life-sustaining treatments within 7 days from screening
• Pregnant
• The responsible clinician feels that the patient either needs low or high protein
• Patient requires parenteral nutrition only and site does not have products to reach the high protein dose group.

Sponsors & Collaborators

• Clinical Evaluation Research Unit at Kingston General Hospital: lead

Related Publications (75)

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• Janz DR, Semler MW, Lentz RJ, Matthews DT, Assad TR, Norman BC, Keriwala RD, Ferrell BA, Noto MJ, Shaver CM, Richmond BW, Zinggeler Berg J, Rice TW; Facilitating EndotracheaL intubation by Laryngoscopy technique and apneic Oxygenation Within the ICU Investigators and the Pragmatic Critical Care Research Group. Randomized Trial of Video Laryngoscopy for Endotracheal Intubation of Critically Ill Adults. Crit Care Med. 2016 Nov;44(11):1980-1987. doi: 10.1097/CCM.0000000000001841.

  PMID: 27355526 BACKGROUND

• Semler MW, Janz DR, Lentz RJ, Matthews DT, Norman BC, Assad TR, Keriwala RD, Ferrell BA, Noto MJ, McKown AC, Kocurek EG, Warren MA, Huerta LE, Rice TW; FELLOW Investigators; Pragmatic Critical Care Research Group. Randomized Trial of Apneic Oxygenation during Endotracheal Intubation of the Critically Ill. Am J Respir Crit Care Med. 2016 Feb 1;193(3):273-80. doi: 10.1164/rccm.201507-1294OC.

  PMID: 26426458 BACKGROUND

• Canadian Critical Care Trials Group. A randomized trial of diagnostic techniques for ventilator-associated pneumonia. N Engl J Med. 2006 Dec 21;355(25):2619-30. doi: 10.1056/NEJMoa052904.

  PMID: 17182987 BACKGROUND

• Heyland D, Muscedere J, Wischmeyer PE, Cook D, Jones G, Albert M, Elke G, Berger MM, Day AG; Canadian Critical Care Trials Group. A randomized trial of glutamine and antioxidants in critically ill patients. N Engl J Med. 2013 Apr 18;368(16):1489-97. doi: 10.1056/NEJMoa1212722.

  PMID: 23594003 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Malnutrition

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Daren K Heyland, MD

  Clinical Evaluation Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: January 27, 2020
• Study Start: November 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: June 18, 2020

Record last verified: 2020-06