Clinical trial NCT01934595: Optimal Protein Supplementation for Critically Ill Patients
Official title: Optimal Protein Supplementation for Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Critical Illness
Keywords: Critically ill
Protein
Supplement
ICU
Protein synthesis
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2013-09-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is well accepted that during critical illness there is an increase in protein breakdown and loss of lean body mass. Previous studies have shown that during critical illness muscle breakdown increases dramatically. The aim of our study is to test the hypothesis that critically ill patients have improved outcomes with higher protein supplementation.


Eligibility criteria: Inclusion Criteria:

* • Medical or surgical patients who are admitted or transferred to the ICU with an APACHE II score greater than or equal to 18 and who are candidates for enteral nutrition within 48 hours of admission.

Exclusion Criteria:

* • Patients who cannot tolerate enteral nutrition

  * Patients who have a contraindication for enteral nutrition per American Society of Enteral and Parenteral Nutrition guidelines (GI obstruction, intractable nausea and/or vomiting, short bowel syndrome, distal GI fistula, GI bleeding that will require endoscopy, malabsorption that requires TPN, inability to access the GI tract
  * Patients with chronic stage III or IV kidney disease and/or patients receiving dialysis within six months of this hospital admission as these patients are known to require specific protein diets as an outpatient. Patients with acute kidney injury will not be excluded as there is no evidence to suggest these patients require a specific protein diet secondary to their acute kidney injury.
  * Patients with refractory hypotension unresponsive to vasoactive medications
  * Patients who are unlikely to survive the next 48 hours at the time of enrollment (this will be judged by the treating physician)
  * Patients who are unable to give consent and do not have a family member able to give consent on his/her behalf.
  * Patients with end stage liver disease or undergoing liver transplant or liver resection surgery
  * Patients whose physician thinks he/she should not participate
  * Prisoners
  * Pregnant women (all female of childbearing age will have a urine pregnancy test prior to randomization)

Primary outcomes:
measure: Cumulative Organ failure free days
timeFrame: 28 days
Secondary outcomes:
measure: Mortality
timeFrame: 28 days
Other outcomes:
measure: Number of days in ICU
timeFrame: 28 days
measure: Infection Rate
timeFrame: 28 days
measure: Discharge location
timeFrame: 28 days
measure: New or Significantly worsening skin breakdown
timeFrame: 28 days
measure: Mechanical Vent free days
timeFrame: 28 days
Locations:
city: Oklahoma City
country: United States
facility: OUHSC
state: Oklahoma
Study officials:
affiliation: OUHSC
name: Karen S Allen, MD
role: PRINCIPAL_INVESTIGATOR
References: