Optimal Protein Supplementation for Critically Ill Patients

Critical Illness Clinical Trial

Official title:

Optimal Protein Supplementation for Critically Ill Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01934595
• Other study ID #: 3440
• Secondary ID: SCCM Vision
• Status: Withdrawn
• Phase: N/A
• First received: August 29, 2013
• Last updated: June 6, 2017
• Start date: September 2013
• Est. completion date: September 2017

Study information

• Verified date: June 2017
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness

Intervention

Dietary Supplement:
• Beneprotein
The study will compare different protein supplementation amounts to determine if increased protein supplementation in critically ill patients improves outcomes.

Locations

Country	Name	City	State
United States	OUHSC	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of days in ICU		28 days
Other	Infection Rate		28 days
Other	Discharge location		28 days
Other	New or Significantly worsening skin breakdown		28 days
Other	Mechanical Vent free days		28 days
Primary	Cumulative Organ failure free 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.	28 days
Secondary	Mortality		28 days