Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00480259
Other study ID # 25351
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2007
Est. completion date April 21, 2009

Study information

Verified date May 2018
Source Milton S. Hershey Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The purpose of this study is threefold. First, to determine if a correlation exists between BUN and nitrogen balance in the context of hyperproteic nutrition administration. Creatinine clearance will also be followed to determine if there is any harmful effect to the kidney secondary to an elevated BUN. Secondly, to determine if there is a difference in hospital acquired infection rate, ventilator days, ICU days, and hospital stay between the current nutrition standard at Penn State Hershey Medical Center and a hyperproteic nutrition protocol. Thirdly, to determine the accuracy of at least three calculated creatinine clearance formulae when compared to a measured creatinine clearance.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date April 21, 2009
Est. primary completion date April 21, 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
hyperproteic nutrition


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Milton S. Hershey Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Increase in BUN Unable to document -incomplete information and investigator no longer at institution; no records available
Secondary 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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT01665664 - Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients N/A
Completed NCT01448135 - Tolerance and Efficacy of a Predigested, High Protein, High Omega 3 Fat Enteral Feeding Formula Versus a Standard Formula In Multiple Intensive Care Unit Settings N/A
Not yet recruiting NCT06072625 - Enteral Feeding of Premature Babies and Olive Oil Supplementation N/A
Completed NCT03385850 - The Th17/Treg Cells and IL-23/IL-17 Axis and Early Enteral Nutrition in Sepsis N/A
Terminated NCT03520582 - Placement of Novel Endoscopic Enteral Feeding Tube
Recruiting NCT02034903 - Effect of Feed Warming Method on Feeding Tolerance in the Preterm Infant Born at Less Than 30 Weeks Gestation N/A
Enrolling by invitation NCT06173063 - Safety and Effectiveness of A Novel Enteral Feeding System: Prospective Study. N/A
Completed NCT05181020 - Studying the Influence of Exposure to Maternal Voice on Oral Feeding Volumes in Preterm Infants N/A
Recruiting NCT05286177 - Does Volume-based Enteral Feeding Improve Nutrient Delivery in Hospitalized Critically Ill Children? N/A
Terminated NCT05848583 - Nutritional Tolerance and Safety of a Tube Feeding Formula N/A
Completed NCT02806427 - Tolerance of a Calorically Dense Enteral Nutrition Formula N/A
Recruiting NCT05838495 - Nutritional Tolerance and Safety of a Tube Feeding Formula in Children N/A
Recruiting NCT05112328 - The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding N/A
Enrolling by invitation NCT04437264 - Intermittent Versus Continuous Enteral Nutrition in Mechanically Ventilated Patients in the Medical Intensive Care Unit N/A
Completed NCT05025267 - Ability to Meet Enteral Nutritional Needs With a Peptide-based, High Protein Formula N/A
Not yet recruiting NCT02973347 - Impact of Intermittent and Continuous Enteral Feeding on Ventilator-associated Pneumonia in Pediatric ICUs N/A
Completed NCT01557673 - Effects of Bolus and Continuous Nasogastric Feeding on Small Bowel Water Content and Blood Flow Phase 1/Phase 2
Recruiting NCT04233333 - Fixation of the Orogastric Tube: Which Method for the Newborn ? N/A
Completed NCT02312271 - Enteral Formula Tolerance of Standard Tube Feedings N/A
Not yet recruiting NCT06189352 - Positive Feeding of the Preterm Infant N/A