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Completed

NCT Number: NCT01383980

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

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.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University (OHSU)

Portland, Oregon, 97201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Tube Feedings

Dietary Supplement

Tube feeds continued up until elective surgery.

Primary outcomes

  1. Total calories delivered

    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.

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

Secondary outcomes

  1. Laboratory values

    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.

    Laboratory values of interest include: CBC, liver function tests, basic metabolic panel, magnesium, phosphate, alubmin, prealubumin, c-reactive protein, and arterial blood gas.

  2. Weight change

    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.

    The change of weight during hospital admission.

  3. number of infections and aspiration events

    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.

    Number of infections or aspiration events during hospitalization

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

A Randomized Trial of Continuous Versus Interrupted Enteral Feeding in Critically Ill Surgical Patients Requiring Mechanical Ventilation

Important dates

Study start
2011
Primary completion
2015
Study completion
2017
First posted
Jun 28, 2011
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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