Clinical trial NCT01383980: 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
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Enteral Nutrition
Enteral Feeding
nasogastric tubes
gastrostomy tubes
jejunostomy tubes
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2011-06-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects are randomized to remain NPO at midnight prior to surgery or to continue to receive tube feeding up until surgery time.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Total calories delivered
timeFrame: 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:
measure: Laboratory values
timeFrame: Daily for length of stay (LOS). LOS defined as time from admission to discharge. LOS estimated to average three (3) weeks per participant.
measure: Weight change
timeFrame: Daily for length of stay (LOS). LOS defined as time from admission to discharge. LOS estimated to average three (3) weeks per participant.
measure: number of infections and aspiration events
timeFrame: 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.
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University (OHSU)
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Laszlo Kiraly, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.