Optimal Protein Supplementation for Critically Ill Patients

NCT ID: NCT01934595

Last Updated: 2017-06-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2017-09-30

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.

Conditions

Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Varying amounts of Beneprotein

1.5grams/kg/day, 2.0 grams/kg/day, and 2.5 grams/kg, day

Group Type: EXPERIMENTAL

Beneprotein

Intervention Type: DIETARY_SUPPLEMENT

The study will compare different protein supplementation amounts to determine if increased protein supplementation in critically ill patients improves outcomes.

1 Gram - Standard Therapy given in ICU

1 gram/kg/day of protein

Group Type: ACTIVE_COMPARATOR

Beneprotein

Intervention Type: DIETARY_SUPPLEMENT

The study will compare different protein supplementation amounts to determine if increased protein supplementation in critically ill patients improves outcomes.

Interventions

Beneprotein

The study will compare different protein supplementation amounts to determine if increased protein supplementation in critically ill patients improves outcomes.

Intervention Type: DIETARY_SUPPLEMENT

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen S Allen, MD

Role: PRINCIPAL_INVESTIGATOR

OUHSC

Locations

OUHSC

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

SCCM Vision

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

3440

Identifier Type: -

Identifier Source: org_study_id