NCT00480259

Brief Summary

This study is designed to determine if the following are true. When protein requirements exceed metabolic requirements, blood urea nitrogen(BUN) levels will rise. Elevated BUN levels in the absence of renal failure, hepatic failure, or GI bleeding, will be correlated with improved nitrogen balance and inversely correlated with infection rates, days of mechanical ventilation, ICU days, and total hospital days.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2007

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 30, 2007

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2009

Completed
Last Updated

June 1, 2018

Status Verified

May 1, 2018

Enrollment Period

1.9 years

First QC Date

May 29, 2007

Last Update Submit

May 30, 2018

Conditions

Enteral Feeding

Keywords

blood urea nitrogennitrogen balancenutritionintensive care

Outcome Measures

Primary Outcomes (1)

  • Increase in BUN

    Unable to document -incomplete information and investigator no longer at institution; no records available

Secondary Outcomes (1)

  • Decrease in infection rate, ventilator days, ICU stay and hospital dys

    Unable to document -incomplete information and investigator no longer at institution; no records available

Study Arms (2)

Standard Nutrition

ACTIVE COMPARATOR
Behavioral: hyperproteic nutrition

Hyperprotein Nutrition

EXPERIMENTAL
Behavioral: hyperproteic nutrition

Interventions

hyperproteic nutritionBEHAVIORAL
Hyperprotein NutritionStandard Nutrition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Greater then or equal to 18 years of age and patient in Intensive Care Unit
  • Receiving enteral nutrition, with expected duration of at least 5 days
  • Blood urea nitrogen and creatinine clearance are part of routine blood work
  • Indwelling urinary catheter in place

You may not qualify if:

  • Renal or hepatic failure
  • Current or history(past 6 mos) of GI bleeding
  • Serum creatinine on day of screening of equal to or greater then 1.5 mg/dl
  • Creatinine Clearance on day of screening of equal to or less then 30ml/min
  • Hypovolemia resulting in increased BUN
  • Septic shock
  • Blood urea nitrogen on day of screening equal to or greater then 30mg/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • John K Stene, MD

    Penn State University, College of Medicine, Dept of Anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2007

First Posted

May 30, 2007

Study Start

June 1, 2007

Primary Completion

April 21, 2009

Study Completion

April 21, 2009

Last Updated

June 1, 2018

Record last verified: 2018-05