Optimal Protein Supplementation for Critically Ill Patients

NCT01934595 | Withdrawn DMC

• 2 other identifiers: 3440SCCM Vision
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Critically ill; Protein; Supplement; ICU; Protein synthesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mortality

  28 days

Other Outcomes (5)

• Number of days in ICU

  28 days

• Infection Rate

  28 days

• Discharge location

  28 days

Study Arms (2)

Varying amounts of Beneprotein

EXPERIMENTAL

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

Dietary Supplement: Beneprotein

1 Gram - Standard Therapy given in ICU

ACTIVE COMPARATOR

1 gram/kg/day of protein

Dietary Supplement: Beneprotein

Interventions

Beneprotein 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; Varying amounts of Beneprotein

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

OUHSC

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen S Allen, MD

  OUHSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: September 4, 2013
• Study Start: September 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: September 1, 2017
• Last Updated: June 7, 2017

Record last verified: 2017-06

Locations

US (1)