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

NCT00802503 | Completed Phase 3 Results

• 1 other identifier: Protocole 07-098
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 2

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.

Conditions

Critically Ill

Keywords

Critically ill; nutrition; randomised controlled clinical trial; human; adult; Supplemental parenteral nutrition

Outcome Measures

Primary Outcomes (1)

• Documented Infection Rate

  Infection, defined according to CDC criteria during the ICU and hospital stay, occurrence between day 9 and day 28

  20 days

Secondary Outcomes (8)

• Hours on Mechanical Ventilation in All Patients

  28 days

• Antibiotic Free Days

  20 days

• Total Energy Intake During the Intervention Period , Between Day 4 and Day 8.

  5 days

• General Mortality

  28 days

• Days in ICU

  28 days

Study Arms (2)

SPN group

EXPERIMENTAL

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.

Dietary Supplement: SPN

Control gr

NO INTERVENTION

EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.

Interventions

SPN DIETARY_SUPPLEMENT

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.

SPN group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead
• University of Lausanne Hospitals: collaborator

Study Sites (2)

Service of Intensive Care, Geneva University Hospital,

Geneva, 1211, Switzerland

Location

Service de Médecine Intensive Adulte et Centre des Brûlés

Lausanne, 1011, Switzerland

Location

Related Publications (2)

• 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. doi: 10.1007/s00134-007-0654-7. Epub 2007 Apr 28.

  PMID: 17468845 BACKGROUND

• Heidegger CP, Berger MM, Graf S, Zingg W, Darmon P, Costanza MC, Thibault R, Pichard C. Optimisation of energy provision with supplemental parenteral nutrition in critically ill patients: a randomised controlled clinical trial. Lancet. 2013 Feb 2;381(9864):385-93. doi: 10.1016/S0140-6736(12)61351-8. Epub 2012 Dec 3.

  PMID: 23218813 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The trial was limited by the fact that it was not double blinded by design. However, the risk of bias was reduced because the investigators worked independently from the physicians in charge of the patients.

Results Point of Contact

• Title: Dr CP Heidegger
• Organization: Geneva University Hospitals, Division of Intensive Care,Rue Gabrielle Perret Gentil 4, CH-1211 Geneva 14/Switzerland

claudia-paula.heidegger@hcuge.ch

+41223827440

Study Officials

• Claudia P HEIDEGGER, MD

  Division of Intensive Care, 1211 Geneva 14, Switzerland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy head physician

Study Record Dates

• First Submitted: December 3, 2008
• First Posted: December 5, 2008
• Study Start: May 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: April 19, 2013
• Results First Posted: April 19, 2013

Record last verified: 2013-04

Locations

CH (2)