Impact of Supplemental Parenteral Nutrition in ICU Patients on Metabolic, Inflammatory and Immune Responses (SPN2)

Vaud University Hospital Center

Status: Completed

Conditions: Critical Illness

Treatments: Dietary Supplement: Supplemental parenteral nutrition (SPN)

Study type: Interventional

Funder types: Other

Identifiers

NCT02022813

CE 371-13

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 28 patients

Sex: All

Ages: 16 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

Enteral nutrition only

No Intervention group

Description:

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)

Supplemental parenteral nutrition

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Supplemental parenteral nutrition (SPN)