Optimal Protein Supplementation for Critically Ill Patients

University of Oklahoma1 site in 1 countrySeptember 2013

ConditionsCritical Illness

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Critical Illness
Sponsor: University of Oklahoma
Locations: 1
Primary Endpoint: Cumulative Organ failure free days
Status: Withdrawn
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2013

End Date

September 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Oklahoma

Responsible Party

Sponsor

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)

Outcomes

Primary Outcomes

Cumulative Organ failure free days

Time Frame: 28 days

The primary outcome will be cumulative organ failure free days (defined as no aggressive medical support for the patient's vital organ systems; including cardiovascular, respiratory, renal, bone marrow, and liver.