Effect of Location of Feeding on Glycemic Control in Critically Ill Patients (ELF)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-09-01

Brief Summary

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The purpose of this study is to investigate the effect of location of feeding on glycemic control in critically ill patients.

The investigators hypothesize that glycemic control in critically ill patients who receive enteral nutrition through postpyloric location (beyond stomach) will have better glycemic control compared to critically ill patients fed gastrically.

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Detailed Description

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Randomization will happen after initial stabilization phase which may last up to 24 hours till when patient may or may not have an enteric access. If enteral access is gained and patient is screened in for the study using inclusion and exclusion criteria, a consent shall be obtained for enrollment. The tube may be continued to be used if randomized in group A. If patient is randomized to group B, a postpyloric placement will be achieved.

Randomization using computer software and a unique identification number will be assigned to every intubated patients who may need mechanical ventilation or tube feed for more than 48 hours.

Randomization will be considered incomplete and the case will be excluded if the process of assigning group, confirmation of placement of appropriate group specific tube and nutrition is not initiated within 24 hours.

If patient is randomized into group A, a bedside RN or the intensivist will place a Salem Sump gastric tube. A nutrition consult for tube feed will be obtained. Confirmation of gastric placement and not a postpyloric placement will be based on the length of the orogastric/nasogastric tube and a standard chest radiograph obtained routinely after intubation. The NG or OG tube should not be more than 65 cm in most cases to prevent it from migrating into the postpyloric location. A standard enteral tube feed formula will be initiated. Blood sugars checked via basic metabolic (at least daily) panel and point-of-care glucose tests (at least every 6 hours) will be obtained. Data collection and Salem Sump placement will be confirmed by the studying team and will not be known to the RD prescribing the nutrition.

If a patient is randomized into group B, a trained RN or RD will place the small-bore feeding feeding tube in the postpyloric position. The effort will be to assure jejunal placement, but postpyloric placement should be sufficient. If for some reason, the small-bore tube cannot be passed beyond pylorus, then sufficient length will be left in IRB the stomach and the case will be noted to have not had the postpyloric placement.

A per protocol analysis and an intention to treat analysis will be carried in the end to take into consideration cases when placement of tube in certain location could not be achieved.

If a feeding tube becomes occluded, it will be replaced with a new tube within 12 hours. If the patient had a postpyloric tube and the new tube cannot be positioned in the postpyloric location, the patient's involvement in the study will be halted (no further data collection).

A standard enteral tube feed formula will be initiated. Blood sugars checked via basic metabolic (at least daily) panel and point-of-care glucose tests (at least every 6 hours) will be obtained.

Conditions

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Glucose Metabolism Disorders Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Gastric Tube Placement

Nasoenteric tube placed in the stomach.

Group Type ACTIVE_COMPARATOR

Gastric

Intervention Type PROCEDURE

Placement of a nasoenteric tube

Small bowel

Nasoenteric tube placed in the small bowel.

Group Type EXPERIMENTAL

Gastric

Intervention Type PROCEDURE

Placement of a nasoenteric tube

Interventions

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Gastric

Placement of a nasoenteric tube

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Adult (18 years or above) patients admitted in the critical care unit on mechanical ventilation for at least 48 hours
2. Orders for tube feeding

Exclusion Criteria

1. Intubated for less than 48 hours (suspected insufficient time for the role of feeding mode to affect glycemic control)
2. Patients not being fed (such as DKA, GI bleed, obstruction, ileus, etc)
3. Pre-existing PEG/PEJ tubes
4. Surgically altered upper and middle GI tract such as partial gastrectomy, gastric bypass surgeries etc. (patients with ileostomy and colostomy may still be included if the enteral route is used for nutrition)
5. No informed consent
6. Primary attending finds medical necessity to have a specific type of tube preventing randomization

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes