Impact of SPN on Infection Rate, Duration of Mechanical Ventilation & Rehabilitation in ICU Patients

Phase 3

Completed

Conditions: Critically Ill

Interventions: Dietary Supplement: SPN

Registration Number: NCT00802503

Lead Sponsor: University Hospital, Geneva

Brief Summary: Rationale: Enteral nutrition (EN) in the intensive care (ICU) patients is recommended as a standard of care. However, EN alone is often associated with insufficient energy intakes and increased complication rates. Recently the investigators proposed to decrease this deficit by combining EN and supplemental parenteral nutrition (SPN) whenever EN is insufficient (\< 60% of their predicted energy needs) at day 3 after admission in the ICU.

Objective: This study aims at: a/ investigating if the delivery of optimal nutrition support (100 % of predicted energy targets) in ICU patients by the combined administration of SPN and EN optimizes their clinical outcome; b/ implementing the new ICU nutrition guidelines.

Study design: Prospective, controlled, randomized clinical study.

Study site: Service of Intensive Care, Geneva University Hospital.

Patient population: 220 ICU patients to be included: expected length of stay \> 5 days, expected survival \> 7 days, no contraindication to EN, obtained informed consent from themselves or their next of keen.

Exclusion criteria: refusal of consent, age \< 18 years, short bowel syndrome, significant persistent gastrointestinal dysfunction with ileus, high output proximal fistula (\> 1,5 liter/d), patients receiving PN.

Nutrition: At day 3 after admission, if energy input is \< 60%; patients are randomized into either the "Control group" (EN alone) or the "SPN group" (EN + PN) to reach 100% of their predicted energy needs. Tight glycaemic control (target 6.0 to 8.3 mmol/l) to be achieved according to our local practice by insulin administration.

Study endpoints:

* Primary: nosocomial infections (CDC criteria)

* Secondary: Mechanical ventilation duration, ICU and hospital length of stay, antibiotic free days, ICU complications (extra-renal epuration, neurological, cardiac and respiratory complications), energy and protein balance, 28 days clinical outcome.

Detailed Description: Introduction:

Nutritional support of the intensive care (ICU) patients is recommended as a standard of care. It is also strongly recommended to start enteral feeding as soon as possible whenever the gastrointestinal tract is functioning (1). However, studies have repeatedly shown that with enteral support alone, insufficient energy and protein intakes often occur (2). The resulting energy and protein deficit is associated with an increased complication rate in ICU patients (3-5). Recently we proposed to decrease this deficit by promoting a combined nutrition support by enteral nutrition (EN) and supplemental parenteral nutrition (SPN) whenever EN is insufficient (6).

Contrary to former beliefs, recent meta-analyses show that parenteral nutrition (PN) does not carry excess mortality (7, 8). These reports convey a concept that is a major break-through in current routine of nutritional support in ICU patients by promoting a much wider use of PN. SPN could be the optimal modality to provide the calculated energy targets if this cannot be reached by EN alone. To improve ICU patient's outcome and minimise complications, we propose to implement feeding protocols which combine both EN and PN, when EN is insufficient to cover more than 60% of caloric needs at day 4 to reach 100% of the energy targets by adding PN from day 4 (6).

Hypothesis:

The administration of SPN, in ICU patients receiving \< 60% of targeted energy needs by EN alone, has a positive impact on their clinical outcome by optimising their nutritional support (reduced infectious complications rate, mechanical ventilation days, duration of ICU and hospital length of stay and rehabilitation).

Objective:

The aim of the present study is to investigate if the delivery of optimal nutrition support (100 % of predicted energy targets) in ICU patients achieved with the combined administration of SPN and EN optimizes their clinical outcome.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 305

Inclusion Criteria

Expected ICU stay > 5 days
Expected survival > 7 days
No contraindication to EN
Obtained informed consent

Exclusion Criteria

Refusal of consent
Age < 18 years
Short bowel syndrome
Significant persistent gastrointestinal dysfunction with ileus
High output proximal fistula (> 1.5 liter/d)
Patients receiving PN

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPN group	SPN	experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4. In the treated group, SPN is started if at day 4 energy input by EN is \< 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.

Primary Outcome Measures

Name	Time	Method
Documented Infection Rate	20 days	Infection, defined according to CDC criteria during the ICU and hospital stay, occurrence between day 9 and day 28

Secondary Outcome Measures

Name	Time	Method
Total Energy Intake During the Intervention Period , Between Day 4 and Day 8.	5 days	Percentage of energy target; in the SPN group the goal was to achieve 100% of the energy target during intervention (day 4 to day 8.The energy target was measured by indirect calorimetry in 198 patients of 305(65%),otherwise energy target was calculated by 25 kcal per kg of ideal body weight for women and 30 kcal per kg of ideal body weight for men and anamnestic body weight was used for patients with a body mass index of 20 kg/m2 or lower.
Antibiotic Free Days	20 days	Number of days between day 9 to day 28 (follow-up period) free of antibiotics
General Mortality	28 days
Days in ICU	28 days	Days in ICU
Protein Delivery During the Intervention Period From Day 4 to Day 8	5 days	Percentage of protein target between day 4 to 8. Protein target was set to 1.2 g per kg of ideal body weight a day.
Hours on Mechanical Ventilation in All Patients	28 days	Mechanical ventilation hours during study duration (days 1-28)
ICU Mortality	28 days
Days in Hospital	28 days	hospital length of stay

Trial Locations

Locations (2): Service de Médecine Intensive Adulte et Centre des Brûlés
🇨🇭
Lausanne, Switzerland
Service of Intensive Care, Geneva University Hospital,
🇨🇭
Geneva, Switzerland