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Trial of Continuous Versus Interrupted Feeding for Intubated Intensive Care Unit Patients

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Tube Feedings
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malnutrition focused on measuring Enteral Nutrition, Enteral Feeding, nasogastric tubes, gastrostomy tubes, jejunostomy tubes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Intubated with planned visit to the OR
  • Admitted to an ICU at OHSU
  • Receiving enteral nutrition or plan to start enteral nutrition

Exclusion Criteria:

  • Age less than 18 years
  • Unable to obtain consent from patient or ARR

Sites / Locations

  • Oregon Health & Science University (OHSU)

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Continuous Feeding

Arm Description

Tube feeds are held night prior to elective surgery (standard of care)

Tube feeds are continued up until surgery. Subjects with a nasogastric tube will have their stomach contents emptied prior to surgery.

Outcomes

Primary Outcome Measures

Total calories delivered
The total number of calories subject consume while receiving tube feeding.

Secondary Outcome Measures

Laboratory values
Laboratory values of interest include: CBC, liver function tests, basic metabolic panel, magnesium, phosphate, alubmin, prealubumin, c-reactive protein, and arterial blood gas.
Weight change
The change of weight during hospital admission.
number of infections and aspiration events
Number of infections or aspiration events during hospitalization

Full Information

First Posted
June 27, 2011
Last Updated
March 15, 2019
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT01383980
Brief Title
Trial of Continuous Versus Interrupted Feeding for Intubated Intensive Care Unit Patients
Official Title
A Randomized Trial of Continuous Versus Interrupted Enteral Feeding in Critically Ill Surgical Patients Requiring Mechanical Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 2011 (Actual)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Surgical patients fed up until the point of surgery will have safe delivery of more calories compared to a group whose feeding is held at midnight prior to surgery.
Detailed Description
Nutrition is essential for healing and recovery from illness. Tube feeds are the standard care for patients with prolonged stays in the intensive care unit (ICU) who cannot eat food on their own. Tube feeding means that a tube has been placed in a patient's stomach or small intestine to provide nutrition. When a patient is scheduled for an elective surgery, he/she usually has nothing to eat after midnight prior to the operation. A fasting period before surgery is done to avoid possible side effects during the placement of a breathing tube. Having an empty stomach is thought to decrease the chances of vomiting or aspiration while a breathing tube is placed. (Aspiration occurs when a substance, such as food provided by a tube feed, enters the airway.) However, some patients already have a breathing tube in place. The investigators do not know which is better for patients who already have a breathing tube in place: continuing feedings up until surgery or stopping them the night before. The investigators hypothesize intubated surgical patients randomized to a protocol of feeding up until the point of surgery will have the safe delivery of more calories as compared to a group whose feeding is held at midnight prior to surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Enteral Nutrition, Enteral Feeding, nasogastric tubes, gastrostomy tubes, jejunostomy tubes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects are randomized to remain NPO at midnight prior to surgery or to continue to receive tube feeding up until surgery time.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Tube feeds are held night prior to elective surgery (standard of care)
Arm Title
Continuous Feeding
Arm Type
Experimental
Arm Description
Tube feeds are continued up until surgery. Subjects with a nasogastric tube will have their stomach contents emptied prior to surgery.
Intervention Type
Dietary Supplement
Intervention Name(s)
Continuous Tube Feedings
Intervention Description
Tube feeds continued up until elective surgery.
Primary Outcome Measure Information:
Title
Total calories delivered
Description
The total number of calories subject consume while receiving tube feeding.
Time Frame
Daily for length of stay (LOS). LOS defined as time from admission to discharge. LOS estimated to average three (3) weeks per participant.
Secondary Outcome Measure Information:
Title
Laboratory values
Description
Laboratory values of interest include: CBC, liver function tests, basic metabolic panel, magnesium, phosphate, alubmin, prealubumin, c-reactive protein, and arterial blood gas.
Time Frame
Daily for length of stay (LOS). LOS defined as time from admission to discharge. LOS estimated to average three (3) weeks per participant.
Title
Weight change
Description
The change of weight during hospital admission.
Time Frame
Daily for length of stay (LOS). LOS defined as time from admission to discharge. LOS estimated to average three (3) weeks per participant.
Title
number of infections and aspiration events
Description
Number of infections or aspiration events during hospitalization
Time Frame
From date of randomization until the date of documented complication. Subjects will be followed until discharge in case of multiple complications. Date of discharge is estimated to be three (3) weeks post-admission on average.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Intubated with planned visit to the OR Admitted to an ICU at OHSU Receiving enteral nutrition or plan to start enteral nutrition Exclusion Criteria: Age less than 18 years Unable to obtain consent from patient or ARR
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laszlo Kiraly, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University (OHSU)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11566654
Citation
Braunschweig CL, Levy P, Sheean PM, Wang X. Enteral compared with parenteral nutrition: a meta-analysis. Am J Clin Nutr. 2001 Oct;74(4):534-42. doi: 10.1093/ajcn/74.4.534.
Results Reference
background
PubMed Identifier
1616387
Citation
Kudsk KA, Croce MA, Fabian TC, Minard G, Tolley EA, Poret HA, Kuhl MR, Brown RO. Enteral versus parenteral feeding. Effects on septic morbidity after blunt and penetrating abdominal trauma. Ann Surg. 1992 May;215(5):503-11; discussion 511-3. doi: 10.1097/00000658-199205000-00013.
Results Reference
background
PubMed Identifier
9448611
Citation
Kalfarentzos F, Kehagias J, Mead N, Kokkinis K, Gogos CA. Enteral nutrition is superior to parenteral nutrition in severe acute pancreatitis: results of a randomized prospective trial. Br J Surg. 1997 Dec;84(12):1665-9.
Results Reference
background
PubMed Identifier
19398613
Citation
McClave SA, Martindale RG, Vanek VW, McCarthy M, Roberts P, Taylor B, Ochoa JB, Napolitano L, Cresci G; A.S.P.E.N. Board of Directors; American College of Critical Care Medicine; Society of Critical Care Medicine. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr. 2009 May-Jun;33(3):277-316. doi: 10.1177/0148607109335234. No abstract available.
Results Reference
background
PubMed Identifier
8195265
Citation
Jenkins ME, Gottschlich MM, Warden GD. Enteral feeding during operative procedures in thermal injuries. J Burn Care Rehabil. 1994 Mar-Apr;15(2):199-205. doi: 10.1097/00004630-199403000-00019.
Results Reference
background
PubMed Identifier
19251911
Citation
Pousman RM, Pepper C, Pandharipande P, Ayers GD, Mills B, Diaz J, Collier B, Miller R, Jensen G. Feasibility of implementing a reduced fasting protocol for critically ill trauma patients undergoing operative and nonoperative procedures. JPEN J Parenter Enteral Nutr. 2009 Mar-Apr;33(2):176-80. doi: 10.1177/0148607108327527.
Results Reference
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Trial of Continuous Versus Interrupted Feeding for Intubated Intensive Care Unit Patients

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