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

Critically Ill Clinical Trial

Official title:

Impact of Supplemental Parenteral Nutrition (SPN) on Infection Rate, Duration of Mechanical Ventilation and Rehabilitation in Intensive Care Unit Patients: A Quality Control Program for the Implementing of New Nutrition Guidelines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00802503
• Other study ID #: Protocole 07-098
• Status: Completed
• Phase: Phase 3
• First received: December 3, 2008
• Last updated: April 18, 2013
• Start date: May 2008
• Est. completion date: July 2011

Study information

• Verified date: April 2013
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Intervention

Dietary Supplement:
• SPN
SPN : 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.

Locations

Country	Name	City	State
Switzerland	Service of Intensive Care, Geneva University Hospital,	Geneva
Switzerland	Service de Médecine Intensive Adulte et Centre des Brûlés	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Heidegger CP, Romand JA, Treggiari MM, Pichard C. Is it now time to promote mixed enteral and parenteral nutrition for the critically ill patient? Intensive Care Med. 2007 Jun;33(6):963-9. Epub 2007 Apr 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Documented Infection Rate	Infection, defined according to CDC criteria during the ICU and hospital stay, occurrence between day 9 and day 28	20 days	No
Secondary	Hours on Mechanical Ventilation in All Patients	Mechanical ventilation hours during study duration (days 1-28)	28 days	No
Secondary	Antibiotic Free Days	Number of days between day 9 to day 28 (follow-up period) free of antibiotics	20 days	No
Secondary	Total Energy Intake During the Intervention Period , Between Day 4 and Day 8.	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.	5 days	No
Secondary	General Mortality		28 days	No
Secondary	Days in ICU	Days in ICU	28 days	No
Secondary	ICU Mortality		28 days	No
Secondary	Protein Delivery During the Intervention Period From Day 4 to Day 8	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.	5 days	No
Secondary	Days in Hospital	hospital length of stay	28 days	No