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

NCT01383980 | Completed DMC

• 1 other identifier: 00006259
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition

Keywords

Enteral Nutrition; Enteral Feeding; nasogastric tubes; gastrostomy tubes; jejunostomy tubes

Outcome Measures

Primary Outcomes (1)

• Total calories delivered

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

  Daily for length of stay (LOS). LOS defined as time from admission to discharge. LOS estimated to average three (3) weeks per participant.

Secondary Outcomes (3)

• Laboratory values

  Daily for length of stay (LOS). LOS defined as time from admission to discharge. LOS estimated to average three (3) weeks per participant.

• Weight change

  Daily for length of stay (LOS). LOS defined as time from admission to discharge. LOS estimated to average three (3) weeks per participant.

• number of infections and aspiration events

  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.

Study Arms (2)

Control

NO INTERVENTION

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

Continuous Feeding

EXPERIMENTAL

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

Dietary Supplement: Continuous Tube Feedings

Interventions

Continuous Tube Feedings DIETARY_SUPPLEMENT

Tube feeds continued up until elective surgery.

Continuous Feeding

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University (OHSU)

Portland, Oregon, 97201, United States

Location

Related Publications (6)

• 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.

  PMID: 11566654 BACKGROUND

• 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.

  PMID: 1616387 BACKGROUND

• 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.

  PMID: 9448611 BACKGROUND

• 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.

  PMID: 19398613 BACKGROUND

• 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.

  PMID: 8195265 BACKGROUND

• 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.

  PMID: 19251911 BACKGROUND

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Laszlo Kiraly, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Subjects are randomized to remain NPO at midnight prior to surgery or to continue to receive tube feeding up until surgery time.

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: June 28, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2017
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

US (1)