Critically IllSPIRITNCT01581957
Pilot Study on Gastro-intestinal (GI) Enteral Nutrition (EN) Tolerance in Intensive Care Unit Patients
A study testing Specific Enteral Nutrition and Standard Enteral Nutrition in people with Critically Ill, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
Specifically designed enteral formulations may improve the gastrointestinal tolerance during early enteral nutrition in the critically ill patient. This pilot trial will permit testing the design of the full-scale study providing valuable data on the expected effect of the formulation, the variability, thus helping to… 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?
- Specific Enteral Nutrition and Standard Enteral Nutrition
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2012to Apr 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female older than 18 years of age
- All ICU patients
- Expected ICU stay superior or equal to 5 days
- Anticipated to receive tube feeding for at least 3 days
- Informed consent obtained from patient or close relative
Who cannot join
- Contraindication to enteral nutrition or to the placement of an enteral feeding tube
- On enteral nutrition with superior or equal to 75% of caloric goal administered
- Restriction in full intestinal support including protein administration
- Parenteral nutrition of any kind unless due to enteral nutrition intolerance
- History of allergy or intolerance to the study product components (test or control product)
- Currently under therapeutic limitations. Non functional GI tract
- Unwilling or unable to comply with study treatments
- Currently participating or having participated in another clinical, interventional trial during the last month
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Intensive Care Medicine. Bern University Hospital
Bern, Canton of Bern
About this study
Official title: A Pilot Study to Evaluate the Effect of a Specific Enteral Formulation Designed to Improve Gastrointestinal Tolerance in the Critically Ill Patient
Specifically designed enteral formulations may improve the gastrointestinal tolerance during early enteral nutrition in the critically ill patient.
This pilot trial will permit testing the design of the full-scale study providing valuable data on the expected effect of the formulation, the variability, thus helping to better estimate the required sample size.
- Conditions
- Critically Ill
- Being tested
- Specific Enteral Nutrition, Standard Enteral Nutrition
- Keywords
- Enteral nutrition, critically ill patients
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific Enteral NutritionOther
Patients will receive a Specific EN. The caloric target is 25 Kcal/kg/day to be reached on the third day post-initiation of EN (early enteral nutrition).
Standard Enteral NutritionOther
Patients will receive an equivalent volume and caloric intake of standard formulation. The caloric target is 25 Kcal/kg/day to be reached on the third day post-initiation of EN (early enteral nutrition).
| Study group | Role | What they receive |
|---|---|---|
| Specific Enteral formulation | Active comparator | Not described Receives: Other: Specific Enteral Nutrition |
| Standard enteral formulation | Placebo comparator | Not described Receives: Other: Standard Enteral Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diarrhea-free days during Enteral Nutrition (EN) administration to the patients in the Intensive Care Unit (ICU)
Patients will receive treatment for 10 days maximum
Measured: from EN start until end of treatment or ICU discharge (whatever comes first)
Number of diarrhea events per day during EN administration to the patients in the Intensive Care Unit (ICU)
Patients will receive treatment for 10 days maximum
Measured: from EN start until end of treatment or ICU discharge (whatever comes firts)
Secondary outcomes (19)
Incidence and severity of diarrhea
- Number of patients that experienced diarrhea during ICU stay
- Interruption of EN due to diarrhea
- Presence/absence of electrolyte and acid-base disturbances secondary to diarrhea
Measured: up to 10 days
Presence/absence of other abdominal symptoms
If present: description of abdominal distension, pain, absence of bowel sounds
Measured: up to 10 days
Changes in intra-abdominal pressure
Measured: up to 10 days
Incidence of nausea, vomiting and regurgitation
Measured: up to 10 days
Gastric residual volumes (>500 ml)
Measured: up to 10 days
Need to use any drug interfering with the passage of nutrition
Measured: up to 10 days
Visual analogue scale for abdominal discomfort
Assessed in non-comatose patients
Measured: up to 10 days
Health Economic burden of Diarrhea during EN administration at ICU
- Nurse workload for the management of patients with diarrhea during the EN feeding period in ICU
- Total cost of diarrhea evaluated for each patient who experienced diarrhea (medications, cleaning material, blankets, etc.)
Measured: up to 10 days
For blood glucose control
- Number of events outside the 4.5 to 10 mmol/l glycaemic range
- Need for insulin unit administration during exclusive enteral nutrition
- Need for glucose administration during exclusive enteral nutrition
Measured: up to 10 days
Time to reach the full caloric goal
25 Kcal/kg/day or as determined for each patient with indirect calorimetry
Measured: up to 10 days
Accumulated daily caloric deficit during 72 hs after start of the study
Percentage of cumulative calories delivered vs. prescribed during hospitalization in ICU and accumulated deficit during ICU stay/day (it should be the same)
Measured: up to 10 days
Need for parenteral nutrition supplementation during ICU stay
yes/no, economic impact
Measured: up to 10 days
Nutritional assessment
serum albumin at baseline, 3 days after EN start and at treatment end or at ICU discharge (whatever comes first)
Measured: up to 10 days
Incidence of secondary infections
Measured: up to 10 days
ICU Length of Stay, days on mechanical ventilation during ICU stay (mech. ventilation-free days), hospital LOS (length of stay)
Measured: up to 28 days
Microbiota profiling
Comprehensive intestinal microbiota profiling by sequencing-based approaches in stool samples collected right before initiation of EN, 3 days after EN start, at treatment end or at ICU discharge (whatever comes first), and at diarrhea episodes
Measured: up to 10 days
Determination of diarrhea pathogenicity
Infections, fecal cultures for pathogens assessed at diarrhea episodes
Measured: up to 10 days
Safety evaluation (blood sampling)
End-point of safety evaluation at baseline, 3 days after EN start and at treatment end or at ICU discharge (whatever comes first), will include: blood cell analysis, hemoglobin, hepatic enzymes and creatinine
Measured: up to 10 days
AEs (adverse events) / SAEs (serious adverse events)
AE and SAE reporting from study start until 28 days after randomization
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startDec 2012
- Primary completionFeb 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Société des Produits Nestlé (SPN)The 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephan Jakob, Professor, Principal investigator, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581957
- Sponsor's protocol ID
- 10.10.CLI
- Acronym
- SPIRIT
- Status last verified
- Jun 2014
- First submitted
- 18 Apr 2012
- Last updated
- 27 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Jakob SM, Butikofer L, Berger D, Coslovsky M, Takala J. A randomized controlled pilot study to evaluate the effect of an enteral formulation designed to improve gastrointestinal tolerance in the critically ill patient-the SPIRIT trial. Crit Care. 2017 Jun 10;21(1):140. doi: 10.1186/s13054-017-1730-1.
PubMed 28599662
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Effect of a Specific Enteral Formulation Designed to Improve Gastrointestinal Tolerance in the Critically Ill Patient
- ClinicalTrials.gov ID
- NCT01581957
- Acronym / sponsor ID
- SPIRIT / 10.10.CLI
- Conditions
- Critically Ill
- Keywords
- Enteral nutrition, critically ill patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 20 Apr 2012 (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.
Specifically designed enteral formulations may improve the gastrointestinal tolerance during early enteral nutrition in the critically ill patient.
This pilot trial will permit testing the design of the full-scale study providing valuable data on the expected effect of the formulation, the variability, thus helping to better estimate the required sample size.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specific Enteral formulation | Active comparator | Other: Specific Enteral Nutrition |
| Standard enteral formulation | Placebo comparator | Other: Standard Enteral Nutrition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female older than 18 years of age
- All ICU patients
- Expected ICU stay superior or equal to 5 days
- Anticipated to receive tube feeding for at least 3 days
- Informed consent obtained from patient or close relative
Key exclusion criteria (8 listed)
- Contraindication to enteral nutrition or to the placement of an enteral feeding tube
- On enteral nutrition with superior or equal to 75% of caloric goal administered
- Restriction in full intestinal support including protein administration
- Parenteral nutrition of any kind unless due to enteral nutrition intolerance
- History of allergy or intolerance to the study product components (test or control product)
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 |
|---|---|---|
| Specific Enteral NutritionPatients will receive a Specific EN. The caloric target is 25 Kcal/kg/day to be reached on the third day post-initiation of EN (early enteral nutrition). | Other | Specific Enteral formulation |
| Standard Enteral NutritionPatients will receive an equivalent volume and caloric intake of standard formulation. The caloric target is 25 Kcal/kg/day to be reached on the third day post-initiation of EN (early enteral nutrition). | Other | Standard enteral formulation |
Primary outcome
Diarrhea-free days during Enteral Nutrition (EN) administration to the patients in the Intensive Care Unit (ICU)
Time frame: from EN start until end of treatment or ICU discharge (whatever comes first)
Patients will receive treatment for 10 days maximum
Number of diarrhea events per day during EN administration to the patients in the Intensive Care Unit (ICU)
Time frame: from EN start until end of treatment or ICU discharge (whatever comes firts)
Patients will receive treatment for 10 days maximum
19 secondary outcomes
Incidence and severity of diarrhea
Time frame: up to 10 days
Presence/absence of other abdominal symptoms
Time frame: up to 10 days
Changes in intra-abdominal pressure
Time frame: up to 10 days
Incidence of nausea, vomiting and regurgitation
Time frame: up to 10 days
Gastric residual volumes (>500 ml)
Time frame: up to 10 days
Need to use any drug interfering with the passage of nutrition
Time frame: up to 10 days
Visual analogue scale for abdominal discomfort
Time frame: up to 10 days
Health Economic burden of Diarrhea during EN administration at ICU
Time frame: up to 10 days
For blood glucose control
Time frame: up to 10 days
Time to reach the full caloric goal
Time frame: up to 10 days
Accumulated daily caloric deficit during 72 hs after start of the study
Time frame: up to 10 days
Need for parenteral nutrition supplementation during ICU stay
Time frame: up to 10 days
Nutritional assessment
Time frame: up to 10 days
Incidence of secondary infections
Time frame: up to 10 days
ICU Length of Stay, days on mechanical ventilation during ICU stay (mech. ventilation-free days), hospital LOS (length of stay)
Time frame: up to 28 days
Microbiota profiling
Time frame: up to 10 days
Determination of diarrhea pathogenicity
Time frame: up to 10 days
Safety evaluation (blood sampling)
Time frame: up to 10 days
AEs (adverse events) / SAEs (serious adverse events)
Time frame: up to 28 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 27 Jun 2014.
- Derived from this study: PubMed 28599662Jakob SM, Butikofer L, Berger D, Coslovsky M, Takala J. A randomized controlled pilot study to evaluate the effect of an enteral formulation designed to improve gastrointestinal tolerance in the critically ill patient-the SPIRIT trial. Crit Care. 2017 Jun 10;21(1):140. doi: 10.1186/s13054-017-1730-1.
Related trials for Critically Ill
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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.
Stephan Jakob, Professor principal investigator
Bern University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific Enteral Nutrition and Standard Enteral Nutrition in people with Critically Ill, run by Société des Produits Nestlé (SPN) at 1 site 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 8 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 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Diarrhea-free days during Enteral Nutrition (EN) administration to the patients in the Intensive Care Unit (ICU) (time frame: from EN start until end of treatment or ICU discharge (whatever comes first)). The study lists 2 primary outcomes in all. 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 NCT01581957, which also lists 1 linked publication.
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 27 Jun 2014.