Critical IllnessSPN2NCT02022813
Impact of Supplemental Parenteral Nutrition in ICU Patients on Metabolic, Inflammatory and Immune Responses
A study testing Supplemental parenteral nutrition (SPN) in people with Critical Illness, run by Centre Hospitalier Universitaire Vaudois at 2 sites in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- Supplemental parenteral nutrition (SPN)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Apr 2014to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Switzerland2 sites
Nutrition Unit, Geneva University Hospital
Geneva, Canton of Geneva, 1211
Service of Adult Intensive Care - CHUV
Lausanne, Canton of Vaud, 1011
About this study
Official title: Impact of Supplemental Parenteral Nutrition (SPN) on Energy Balance, and Infection Rate in Intensive Care Patients: Underlying Metabolic, Inflammatory and Immune Mechanisms.
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.
Read the detailed 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.
- Conditions
- Critical Illness
- Being tested
- Supplemental parenteral nutrition (SPN)
- Keywords
- Energy requirements, Glucose turnover, Protein turnover
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplemental parenteral nutrition (SPN)Dietary supplement
Also called Standard industrial PN solutions
The amount of energy delivered by SPN will depend on the indirect calorimetry measurement and actual enteral feed delivery. SPN will be reduced with progressing EN
| Study group | Role | What they receive |
|---|---|---|
| Enteral nutrition only | No intervention | 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 | 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. Receives: Dietary Supplement: Supplemental parenteral nutrition (SPN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose and Leucine turnover
On D04:Infusion after priming of 6.6 2H2 glucose and NaH13CO3 On Day 09-10: Infusion after priming of NaH13CO3 and of L-[1-13C]-Leucine + repeat of the glucose sequence
Measured: 10 days
Secondary outcomes (1)
Immune and inflammatory impact of optimized target feeding
lymphocyte phenotypes: lymphocyte subpopulations (frequency), level of activation (CD69), memory markers, effectors, regulators
- Cluster differentiation CD4, CD8, and natural killer (NK) phenotypes
- Cell inflammatory response (WBA and PBMC) on D4 and D10±1: IL-2, TNF-α, interleukine-6 (IL-6), IL-1, TGF, IL-10, in culture for 24 to 48h ex vivo and post stimulation by memory mix and mitogens.
- Serological inflammatory response (WBA and PBMC) on D4 and D10+1: TNF-α , IL-6, C-reactive protein (CRP): ex vivo with ELISA Nosocomial infections after day 8
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startApr 2014
- Primary completionSep 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Responsible party
- Principal investigator, Mette M Berger, Centre Hospitalier Universitaire Vaudois
- Investigators
- Mette M Berger, MD PhD, Principal investigator, CHUV, Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022813
- Sponsor's protocol ID
- CE 371-13
- Acronym
- SPN2
- Status last verified
- Feb 2016
- First submitted
- 25 Nov 2013
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23218813Berger MM, Pantet O, Jacquelin-Ravel N, Charriere M, Schmidt S, Becce F, Audran R, Spertini F, Tappy L, Pichard C. Supplemental parenteral nutrition improves immunity with unchanged carbohydrate and protein metabolism in critically ill patients: The SPN2 randomized tracer study. Clin Nutr. 2019 Oct;38(5):2408-2416. doi: 10.1016/j.clnu.2018.10.023. Epub 2018 Nov 5.
PubMed 30448193
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Supplemental Parenteral Nutrition (SPN) on Energy Balance, and Infection Rate in Intensive Care Patients: Underlying Metabolic, Inflammatory and Immune Mechanisms.
- ClinicalTrials.gov ID
- NCT02022813
- Acronym / sponsor ID
- SPN2 / CE 371-13
- Conditions
- Critical Illness
- Keywords
- Energy requirements, Glucose turnover, Protein turnover
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Study start
- Apr 2014 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 30 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enteral nutrition only | No intervention | –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 | Dietary Supplement: Supplemental parenteral nutrition (SPN)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. |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Supplemental parenteral nutrition (SPN)Also: Standard industrial PN solutionsThe amount of energy delivered by SPN will depend on the indirect calorimetry measurement and actual enteral feed delivery. SPN will be reduced with progressing EN | Dietary supplement | Supplemental parenteral nutrition |
Primary outcome
Glucose and Leucine turnover
Time frame: 10 days
On D04:Infusion after priming of 6.6 2H2 glucose and NaH13CO3 On Day 09-10: Infusion after priming of NaH13CO3 and of L-[1-13C]-Leucine + repeat of the glucose sequence
1 secondary outcome
Immune and inflammatory impact of optimized target feeding
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Background: 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.
- Derived from this study: PubMed 30448193Berger MM, Pantet O, Jacquelin-Ravel N, Charriere M, Schmidt S, Becce F, Audran R, Spertini F, Tappy L, Pichard C. Supplemental parenteral nutrition improves immunity with unchanged carbohydrate and protein metabolism in critically ill patients: The SPN2 randomized tracer study. Clin Nutr. 2019 Oct;38(5):2408-2416. doi: 10.1016/j.clnu.2018.10.023. Epub 2018 Nov 5.
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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.
Mette M Berger, MD PhD principal investigator
CHUV, Lausanne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplemental parenteral nutrition (SPN) in people with Critical Illness, run by Centre Hospitalier Universitaire Vaudois 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 5 inclusion and 7 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 Feb 2018. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glucose and Leucine turnover (time frame: 10 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 NCT02022813, 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 Feb 2018.