Impact of Supplemental Parenteral Nutrition in ICU Patients on Metabolic, Inflammatory and Immune Responses

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

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-06-30

Brief Summary

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Having previously demonstrated that supplemental parenteral nutrition to complete an insufficient enteral nutrition (EN) between D4 and D8 improves outcome after critical illness, by reducing infectious complications, the present trial aims at investigating the underlying carbohydrate and protein metabolism changes, as well as the immune and inflammatory modulations associated with this improvement.

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Detailed Description

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Enrollment on day 3 of critically ill patients, without contraindication to EN, not achieving 60% of the ICU per protocol energy target.

Intervention: Randomization to either continued pure EN, or from day 4 to supplemental PN to complete EN at target validated by indirect calorimetry.

Measurements: Indirect calorimetry on Days 3, 4, 9 (twice). Primary endpoints = glucose and leucine metabolism On days 4 and 9-10: isotopic investigation of glucose metabolism, and immune and inflammatory responses// Day 9-10: isotopic investigation of protein (leucine) metabolism Secondary endpoints: Insulin requirements, area under the curve (AUC) of blood Glucose, infections after day 9, overall complications, length of mechanical ventilation, of ICU and hospital stay.

Conditions

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Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Enteral nutrition only

Enteral nutrition to be progressed as soon as possible to energy target measured on day 3, and verified on day 4, using the usual facilitators (prokinetics)

Group Type NO_INTERVENTION

No interventions assigned to this group

Supplemental parenteral nutrition

Addition of supplemental parenteral nutrition to complete the gap between energy delivered by enteral feeding and energy target measured on day 4.

Aim: 100% of this target, and not exceeding it, no catch up for energy deficit accumulated before day 4.

Group Type EXPERIMENTAL

Supplemental parenteral nutrition (SPN)

Intervention Type DIETARY_SUPPLEMENT

The amount of energy delivered by SPN will depend on the indirect calorimetry measurement and actual enteral feed delivery. SPN will be reduced with progressing EN

Interventions

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Supplemental parenteral nutrition (SPN)

The amount of energy delivered by SPN will depend on the indirect calorimetry measurement and actual enteral feed delivery. SPN will be reduced with progressing EN

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Standard industrial PN solutions

Eligibility Criteria

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Inclusion Criteria

* estimated duration of ICU stay \> 5 days,
* estimated survival \> 7 days,
* absence of contraindication to EN
* need for mechanical ventilation
* informed consent obtained from patients, close relative, or referring physician

Exclusion Criteria

* refusal of the patient or of the next of kin
* age \< 18 years
* non-functional digestive tract (short bowel, persistent ileus, proximal intestinal fistula high rate \> 1.5 litres/day)
* already receiving PN before Day 3
* absence of a central venous catheter
* women who are pregnant (pregnancy test).
* Admission after cardiac arrest, or severe brain injury

Minimum Eligible Age

16 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No