Critically IllPhase 3NCT00802503
Impact of SPN on Infection Rate, Duration of Mechanical Ventilation & Rehabilitation in ICU Patients
A Phase 3 study testing SPN in people with Critically Ill, run by University Hospital, Geneva at 2 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill
- What is being tested?
- SPN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 2 sitesSwitzerland
- Study dates
- May 2008to Jul 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Expected ICU stay > 5 days
- Expected survival > 7 days
- No contraindication to EN
- Obtained informed consent
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Service of Intensive Care, Geneva University Hospital,
Geneva, 1211
Service de Médecine Intensive Adulte et Centre des Brûlés
Lausanne, 1011
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Critically Ill
- Being tested
- SPN
- Keywords
- Critically ill, nutrition, randomised controlled clinical trial, human, adult, Supplemental parenteral nutrition
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPNDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Documented Infection Rate
Infection, defined according to CDC criteria during the ICU and hospital stay, occurrence between day 9 and day 28
Measured: 20 days
Secondary outcomes (8)
Hours on Mechanical Ventilation in All Patients
Mechanical ventilation hours during study duration (days 1-28)
Measured: 28 days
Antibiotic Free Days
Number of days between day 9 to day 28 (follow-up period) free of antibiotics
Measured: 20 days
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.
Measured: 5 days
General Mortality
Measured: 28 days
Days in ICU
Days in ICU
Measured: 28 days
ICU Mortality
Measured: 28 days
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.
Measured: 5 days
Days in Hospital
hospital length of stay
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Responsible party
- Principal investigator, HEIDEGGER CP, University Hospital, Geneva
- Investigators
- Claudia P HEIDEGGER, MD, Principal investigator, Division of Intensive Care, 1211 Geneva 14, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802503
- Sponsor's protocol ID
- Protocole 07-098
- Status last verified
- Apr 2013
- First submitted
- 3 Dec 2008
- Last updated
- 19 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 17468845Heidegger 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.
PubMed 23218813
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00802503
- Acronym / sponsor ID
- Protocole 07-098
- Conditions
- Critically Ill
- Keywords
- Critically ill, nutrition, randomised controlled clinical trial, human, adult, Supplemental parenteral nutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Study start
- May 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 5 Dec 2008 (estimated)
- Results
- Posted 19 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPN group | Experimental | Dietary Supplement: SPNexperimental 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Expected ICU stay > 5 days
- Expected survival > 7 days
- No contraindication to EN
- Obtained informed consent
Key exclusion criteria (6 listed)
- Refusal of consent
- Age < 18 years
- Short bowel syndrome
- Significant persistent gastrointestinal dysfunction with ileus
- High output proximal fistula (> 1.5 liter/d)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPNSPN : 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. | Dietary supplement | SPN group |
Primary outcome
Documented Infection Rate
Time frame: 20 days
Infection, defined according to CDC criteria during the ICU and hospital stay, occurrence between day 9 and day 28
8 secondary outcomes
Hours on Mechanical Ventilation in All Patients
Time frame: 28 days
Antibiotic Free Days
Time frame: 20 days
Total Energy Intake During the Intervention Period , Between Day 4 and Day 8.
Time frame: 5 days
General Mortality
Time frame: 28 days
Days in ICU
Time frame: 28 days
ICU Mortality
Time frame: 28 days
Protein Delivery During the Intervention Period From Day 4 to Day 8
Time frame: 5 days
Days in Hospital
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17468845Heidegger 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.
- Derived from this study: PubMed 23218813Heidegger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia P HEIDEGGER, MD principal investigator
Division of Intensive Care, 1211 Geneva 14, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SPN in people with Critically Ill, run by University Hospital, Geneva at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Documented Infection Rate (time frame: 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00802503, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2013.