Critical IllnessNCT01922570
Economics of Diarrhoea in Intensive Care Unit
A study testing nutrition in people with Critical Illness, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Enteral nutrition (EN) is the first choice route for nutritional support in ICU patients with a functioning digestive tract. Nevertheless, EN alone is often associated with digestive intolerance, including diarrhoea. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2012to Apr 2013
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with an indication to receive enteral nutrition
Who cannot join
- patients with a contraindication to receive enteral nutrition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Economic Investigation of Diarrhoea During Nutritional Support in Intensive Care Unit Patients
Enteral nutrition (EN) is the first choice route for nutritional support in ICU patients with a functioning digestive tract. Nevertheless, EN alone is often associated with digestive intolerance, including diarrhoea. In case of diarrhoea, EN is often reduced or discontinued, resulting in insufficient energy and protein intakes and increase complications rate in ICU patients. Diarrhoea is more frequent in ICU patients receiving EN that in those without EN or on Parenteral nutrition (PN). This difference is likely to be related to the level of EN administration needed to optimize the coverage of nutritional needs at a time when the gut has reduced absorptive capacity. Diarrhoea is suspected to have a negative economic impact on global cost, because the management of patients with diarrhoea is time-consuming for the nurses and all medical staff, it requires investigations (water and electrolytes balances, microbiology investigations, etc.) and treatments (anti-diarrhoeal drugs, antibiotics, etc). However, the economic impact of diarrhoea related to EN or the combination of EN and PN has never been evaluated in the ICU setting.
Read the detailed description
Rationale: Enteral nutrition (EN) is the first choice route for nutritional support in ICU patients with a functioning digestive tract (1). Nevertheless, EN alone is often associated with digestive intolerance, including diarrhoea (2,3). In case of diarrhoea, EN is often reduced or discontinued, resulting in insufficient energy and protein intakes (4) and increase complications rate in ICU patients (5-7). Diarrhoea is more frequent in ICU patients receiving EN that in those without EN or on PN. This difference is likely to be related to the level of EN administration needed to optimize the coverage of nutritional needs at a time when the gut has reduced absorptive capacity. Diarrhoea is suspected to have a negative economic impact on global cost, because the management of patients with diarrhoea is time-consuming for the nurses and all medical staff, it requires investigations (water and electrolytes balances, microbiology investigations, etc.) and treatments (anti-diarrhoeal drugs, antibiotics, etc). However, the economic impact of diarrhoea related to EN or the combination of EN and PN has never been evaluated in the ICU setting.
Hypothesis: We made the hypothesis that the extra cost related to the combination of EN and PN prescription is compensated by the decrease in cost secondary to a reduced prevalence of EN-related diarrhoea, which means that the combination of EN and PN is cost-efficient strategy for optimal feeding in ICU patients.
It is known that:
- diarrhoea is more frequent in ICU patients with EN than in those without EN,
- the higher the EN delivery rate, the higher the risk of diarrhoea,
- the combination of EN and PN decreases the need for high EN delivery rate to fully cover the patients' nutritional needs.
It is likely that:
- diarrhoea-related care costs of EN are higher than those observed in patients receiving a combination of EN and PN,
- extra costs related to the combination of EN and PN prescription are compensated by the decrease in costs secondary to a reduced prevalence of EN-related diarrhoe,
Study objectives:
- To determine retrospectively the global prevalence of diarrhoea in all the ICU patients during a three month period.
- To determine prospectively the prevalence of diarrhoea in the ICU patients included in the "SPN study" on EN alone or EN + PN. To validate this current prevalence of diarrhoea by comparison to the retrospective prevalence rate in our ICU.
- To determine prospectively the diarrhoea-related overall costs in the patients of the "SPN study" on EN alone or EN + PN.
Study endpoints: Three categories of study endpoints will be assessed: economic, gastrointestinal tolerance, feeding protocol.
- Economic in Swiss francs:
- Nursing time for the management of diarrhoea (changes of bed-clothes and disposable nappies)and of nutritional support (time spent to prepare and administer EN and/or PN solutions, introduction and maintenance of naso-gastric tube, catheters, lines, etc)
- Medical time for prescriptions in seconds of the investigations required by the managment of diarrhoea and of the material costs: drugs (antibiotics, drugs inhibiting motility, etc.), bed-clothes, gloves, disposable nappy, EN and/or PN solutions.
- Gastrointestinal tolerance: Symptoms such as as diarrhoea, defined as liquid stools, defined as three or more liquid stools per day, for at least 1 day, and nausea, vomiting, diarrhoea, flatulence, or constipation.
- Feeding protocol: the route of feeding (EN versus PN), the type, quantities and modalities for delivering nutrition products.
- Inclusion criteria: All patients already included in the "SPN study" receiving.
- Exclusion criteria: none.
- Risk and benefit: The present study will not induce any change to the cares defined in the "SPN study" protocol.
- Additional data recorded to the "SPN study" database:
Clinical data: Diarrhoea: number and frequency of stools for the 5 intervention days (Day 3 and 8) and digestive tolerance: measurements of gastric residues according to ou on-going ICU protocol, frequency of nausea, vomiting, flatulence and constipation.
Economic data: Time measurements for physicians activities using a chronometer:Management of nutritional support, Prescription of nutritional support and micronutrients, Investigations related to the management of nutritional support: upper gastrointestinal endoscopy for the insertion of nasojejunal or nasogastric feeding tube or for the investigation of digestive intolerance, Insertion of central venous catheter, Prescription of drugs for the management of diarrhoea: antibiotics, drugs inhibiting motility, etc., Prescription of investigations for the management of diarrhoea: lower gastrointestinal endoscopy, microbiology for the analysis of stools, blood analysis (electrolytes, renal fucntion, etc)
The cost for each item will be calculated according to the cost of manpower based on mean Swiss data as previously described (8).
- Time measurements for nurses activities using a chronometer:
- Management of nutritional support
- Preparation of nutritional support: installation of pumps, connections of bottles with bags, addition of micronutrients (vitamins and trace elements) and insertion of naso-gastric tube for EN
- Monitoring: calculation and setting of flow rates
- Supervision: noting all observations regarding nutritional support in patient nursing file, changes of bottles and bags
- Management of diarrhoea
- Preparation of anti-diarrhoea drugs or antibiotics
- Nursing cares: cleaning, resetting of bed-clothes, wearing of disposable nappies, wound-dressings The cost for each item will be calculated according to the cost of manpower based on mean Swiss data as previously described (8).
- Material costs
- Drugs: antibiotics, anti-diarrhoea drugs
- Nutritional support: central venous catheters, naso-gastric tubes, cost of one day IV pump utilization, cost of nutrient solutions, additive materials
- Cleaning and disinfections: bed-clothes, gloves, caps, disposable nappy
- Statistics:
All patients included in the "SPN study" (9) will provide prospective data about the association between the type of nutritional support (EN, combination of EN and PN) and the occurrence of diarrhoea. We plan to complete this analysis by measuring the economic criteria, as described in the paragraph 7 above. These data will allow to develop an economic model to be applied to all the data acquired in the SPN study.
- Ethics This study protocol is the addendum no 1 to our existing protocol and which is in full compliance with our institution guidelines. Briefly, this extension of the protocol has been approved by the Chief of the ICU before the procedure has been initiated.
- References
- Kreymann KG, Berger MM, Deutz NE, Hiesmayr M, Jolliet P, Kazandjiev G, et al. ESPEN Guidelines on Enteral Nutrition: Intensive care. Clin Nutr 2006;25(2):210-23
- Homann NH, Kemen M, Fuessenich C, Senkal M, Zumtobel V. Reduction in diarrhea incidence by solute fiber in patients receiving total or supplemental enteral nutrition. J Parenter Enteral Nutr 1994;18:486-90
- Rushdi TA, Pichard C, Khater YH. Control of diarrhea by fiber-enriched diet in ICU patients on enteral nutrition: a prospective randomized controlled trial. Clin Nutr 2004;23:1344-1352
- Genton L, Dupertuis YM, Romand JA, Simonet ML, Jolliet P, Huber O, et al. Higher calorie prescription improves nutrient delivery during the first 5 days of enteral nutrition. Clin Nutr 2004; 23(3):307-15
- Villet S, Chiolero RL, Bollmann MD, Revelly JP, Cayeux RNM, Delarue J, et al. Negative impact of hypocaloric feeding and energy balance on clinical outcome in ICU patients. Clin Nutr 2005;24(4):502-9
- Ibrahim EH, Mehringer L, Prentice D, Sherman G, Schaiff R, Fraser V, et al. Early versus late enteral feeding of mechanically ventilated patients: results of a clinical trial. JPEN J Parenter Enteral Nutr 2002;26(3):174-81
- Artinian V, Krayem H, DiGiovine B. Effects of early enteral feeding on the outcome of critically ill mechanically ventilated medical patients. Chest 2006;129(4):960-7
- Pichard C, Schwarz G, Frei A, Kyle U, Jolliet P, Morel P, Romand JA, Sierro C. Economic investigation of the use of three-compartment total parenteral nutrition bag: prospective randomized unblinded controlled study. Clin Nutr 2000;19:245-251
- Heidegger CP, Berger MM, Graf S, et al. (2013). Optimization of energy provision with supplemental parenteral nutrition (SPN) improves the clinical outcome of critically ill patients : a randomized controlled trial. Lancet 381: 385-393
- Conditions
- Critical Illness
- Being tested
- nutrition
- Keywords
- Enteral nutrition, Supplemental parenteral nutrition, Critical illness, ICU patients, diarrhea
- Medical subject headings
- Critical Illness, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritionDietary supplement
Also called Enteral+parenteral nutrition
comparion of enteral versus enteral and supplemental parenteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplements:parenteral nutrition | Experimental | supplemental parenteral nutrition and enteral nutrition in case of failure (intake below 60% of energy needs) of enteral nutrition by day 3 after admission in the ICU or enteral nutrition only. Receives: Dietary Supplement: nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost of diarrhea
Swiss francs: All costs (manpower, investigations, treatments) related to diarrhea during the ICU stay up to 28 days are reported as Swiss francs
Measured: day 28
Secondary outcomes (1)
Use of enteral nutrition
The use of enteral nutrition during the ICU stay and its association with the occurence of diarrhea will recorded
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionApr 2013
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 Critical IllnessStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Claude Pichard, University Hospital, Geneva
- Investigators
- Claude Pichard, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922570
- Sponsor's protocol ID
- NAC 07-098
- Status last verified
- Aug 2013
- First submitted
- 24 Jun 2013
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Heidegger CP, Graf S, Perneger T, Genton L, Oshima T, Pichard C. The burden of diarrhea in the intensive care unit (ICU-BD). A survey and observational study of the caregivers' opinions and workload. Int J Nurs Stud. 2016 Jul;59:163-8. doi: 10.1016/j.ijnurstu.2016.04.005. Epub 2016 Apr 20.
PubMed 27222461
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Investigation of Diarrhoea During Nutritional Support in Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT01922570
- Acronym / sponsor ID
- NAC 07-098
- Conditions
- Critical Illness
- Keywords
- Enteral nutrition, Supplemental parenteral nutrition, Critical illness, ICU patients, diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 14 Aug 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.
Enteral nutrition (EN) is the first choice route for nutritional support in ICU patients with a functioning digestive tract. Nevertheless, EN alone is often associated with digestive intolerance, including diarrhoea. In case of diarrhoea, EN is often reduced or discontinued, resulting in insufficient energy and protein intakes and increase complications rate in ICU patients. Diarrhoea is more frequent in ICU patients receiving EN that in those without EN or on Parenteral nutrition (PN). This difference is likely to be related to the level of EN administration needed to optimize the coverage of nutritional needs at a time when the gut has reduced absorptive capacity. Diarrhoea is suspected to have a negative economic impact on global cost, because the management of patients with diarrhoea is time-consuming for the nurses and all medical staff, it requires investigations (water and electrolytes balances, microbiology investigations, etc.) and treatments (anti-diarrhoeal drugs, antibiotics, etc). However, the economic impact of diarrhoea related to EN or the combination of EN and PN has never been evaluated in the ICU setting.
Detailed description
Rationale: Enteral nutrition (EN) is the first choice route for nutritional support in ICU patients with a functioning digestive tract (1). Nevertheless, EN alone is often associated with digestive intolerance, including diarrhoea (2,3). In case of diarrhoea, EN is often reduced or discontinued, resulting in insufficient energy and protein intakes (4) and increase complications rate in ICU patients (5-7). Diarrhoea is more frequent in ICU patients receiving EN that in those without EN or on PN. This difference is likely to be related to the level of EN administration needed to optimize the coverage of nutritional needs at a time when the gut has reduced absorptive capacity. Diarrhoea is suspected to have a negative economic impact on global cost, because the management of patients with diarrhoea is time-consuming for the nurses and all medical staff, it requires investigations (water and electrolytes balances, microbiology investigations, etc.) and treatments (anti-diarrhoeal drugs, antibiotics, etc). However, the economic impact of diarrhoea related to EN or the combination of EN and PN has never been evaluated in the ICU setting.
Hypothesis: We made the hypothesis that the extra cost related to the combination of EN and PN prescription is compensated by the decrease in cost secondary to a reduced prevalence of EN-related diarrhoea, which means that the combination of EN and PN is cost-efficient strategy for optimal feeding in ICU patients.
It is known that:
- diarrhoea is more frequent in ICU patients with EN than in those without EN,
- the higher the EN delivery rate, the higher the risk of diarrhoea,
- the combination of EN and PN decreases the need for high EN delivery rate to fully cover the patients' nutritional needs.
It is likely that:
- diarrhoea-related care costs of EN are higher than those observed in patients receiving a combination of EN and PN,
- extra costs related to the combination of EN and PN prescription are compensated by the decrease in costs secondary to a reduced prevalence of EN-related diarrhoe,
Study objectives:
- To determine retrospectively the global prevalence of diarrhoea in all the ICU patients during a three month period.
- To determine prospectively the prevalence of diarrhoea in the ICU patients included in the "SPN study" on EN alone or EN + PN. To validate this current prevalence of diarrhoea by comparison to the retrospective prevalence rate in our ICU.
- To determine prospectively the diarrhoea-related overall costs in the patients of the "SPN study" on EN alone or EN + PN.
Study endpoints: Three categories of study endpoints will be assessed: economic, gastrointestinal tolerance, feeding protocol.
- Economic in Swiss francs:
- Nursing time for the management of diarrhoea (changes of bed-clothes and disposable nappies)and of nutritional support (time spent to prepare and administer EN and/or PN solutions, introduction and maintenance of naso-gastric tube, catheters, lines, etc)
- Medical time for prescriptions in seconds of the investigations required by the managment of diarrhoea and of the material costs: drugs (antibiotics, drugs inhibiting motility, etc.), bed-clothes, gloves, disposable nappy, EN and/or PN solutions.
- Gastrointestinal tolerance: Symptoms such as as diarrhoea, defined as liquid stools, defined as three or more liquid stools per day, for at least 1 day, and nausea, vomiting, diarrhoea, flatulence, or constipation.
- Feeding protocol: the route of feeding (EN versus PN), the type, quantities and modalities for delivering nutrition products.
- Inclusion criteria: All patients already included in the "SPN study" receiving.
- Exclusion criteria: none.
- Risk and benefit: The present study will not induce any change to the cares defined in the "SPN study" protocol.
- Additional data recorded to the "SPN study" database:
Clinical data: Diarrhoea: number and frequency of stools for the 5 intervention days (Day 3 and 8) and digestive tolerance: measurements of gastric residues according to ou on-going ICU protocol, frequency of nausea, vomiting, flatulence and constipation.
Economic data: Time measurements for physicians activities using a chronometer:Management of nutritional support, Prescription of nutritional support and micronutrients, Investigations related to the management of nutritional support: upper gastrointestinal endoscopy for the insertion of nasojejunal or nasogastric feeding tube or for the investigation of digestive intolerance, Insertion of central venous catheter, Prescription of drugs for the management of diarrhoea: antibiotics, drugs inhibiting motility, etc., Prescription of investigations for the management of diarrhoea: lower gastrointestinal endoscopy, microbiology for the analysis of stools, blood analysis (electrolytes, renal fucntion, etc)
The cost for each item will be calculated according to the cost of manpower based on mean Swiss data as previously described (8).
- Time measurements for nurses activities using a chronometer:
- Management of nutritional support
- Preparation of nutritional support: installation of pumps, connections of bottles with bags, addition of micronutrients (vitamins and trace elements) and insertion of naso-gastric tube for EN
- Monitoring: calculation and setting of flow rates
- Supervision: noting all observations regarding nutritional support in patient nursing file, changes of bottles and bags
- Management of diarrhoea
- Preparation of anti-diarrhoea drugs or antibiotics
- Nursing cares: cleaning, resetting of bed-clothes, wearing of disposable nappies, wound-dressings The cost for each item will be calculated according to the cost of manpower based on mean Swiss data as previously described (8).
- Material costs
- Drugs: antibiotics, anti-diarrhoea drugs
- Nutritional support: central venous catheters, naso-gastric tubes, cost of one day IV pump utilization, cost of nutrient solutions, additive materials
- Cleaning and disinfections: bed-clothes, gloves, caps, disposable nappy
- Statistics:
All patients included in the "SPN study" (9) will provide prospective data about the association between the type of nutritional support (EN, combination of EN and PN) and the occurrence of diarrhoea. We plan to complete this analysis by measuring the economic criteria, as described in the paragraph 7 above. These data will allow to develop an economic model to be applied to all the data acquired in the SPN study.
- Ethics This study protocol is the addendum no 1 to our existing protocol and which is in full compliance with our institution guidelines. Briefly, this extension of the protocol has been approved by the Chief of the ICU before the procedure has been initiated.
- References
- Kreymann KG, Berger MM, Deutz NE, Hiesmayr M, Jolliet P, Kazandjiev G, et al. ESPEN Guidelines on Enteral Nutrition: Intensive care. Clin Nutr 2006;25(2):210-23
- Homann NH, Kemen M, Fuessenich C, Senkal M, Zumtobel V. Reduction in diarrhea incidence by solute fiber in patients receiving total or supplemental enteral nutrition. J Parenter Enteral Nutr 1994;18:486-90
- Rushdi TA, Pichard C, Khater YH. Control of diarrhea by fiber-enriched diet in ICU patients on enteral nutrition: a prospective randomized controlled trial. Clin Nutr 2004;23:1344-1352
- Genton L, Dupertuis YM, Romand JA, Simonet ML, Jolliet P, Huber O, et al. Higher calorie prescription improves nutrient delivery during the first 5 days of enteral nutrition. Clin Nutr 2004; 23(3):307-15
- Villet S, Chiolero RL, Bollmann MD, Revelly JP, Cayeux RNM, Delarue J, et al. Negative impact of hypocaloric feeding and energy balance on clinical outcome in ICU patients. Clin Nutr 2005;24(4):502-9
- Ibrahim EH, Mehringer L, Prentice D, Sherman G, Schaiff R, Fraser V, et al. Early versus late enteral feeding of mechanically ventilated patients: results of a clinical trial. JPEN J Parenter Enteral Nutr 2002;26(3):174-81
- Artinian V, Krayem H, DiGiovine B. Effects of early enteral feeding on the outcome of critically ill mechanically ventilated medical patients. Chest 2006;129(4):960-7
- Pichard C, Schwarz G, Frei A, Kyle U, Jolliet P, Morel P, Romand JA, Sierro C. Economic investigation of the use of three-compartment total parenteral nutrition bag: prospective randomized unblinded controlled study. Clin Nutr 2000;19:245-251
- Heidegger CP, Berger MM, Graf S, et al. (2013). Optimization of energy provision with supplemental parenteral nutrition (SPN) improves the clinical outcome of critically ill patients : a randomized controlled trial. Lancet 381: 385-393
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary supplements:parenteral nutrition | Experimental | Dietary Supplement: nutritionsupplemental parenteral nutrition and enteral nutrition in case of failure (intake below 60% of energy needs) of enteral nutrition by day 3 after admission in the ICU or enteral nutrition only. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with an indication to receive enteral nutrition
Key exclusion criteria (1 listed)
- patients with a contraindication to receive enteral nutrition
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 |
|---|---|---|
| nutritionAlso: Enteral+parenteral nutritioncomparion of enteral versus enteral and supplemental parenteral nutrition | Dietary supplement | Dietary supplements:parenteral nutrition |
Primary outcome
Cost of diarrhea
Time frame: day 28
Swiss francs: All costs (manpower, investigations, treatments) related to diarrhea during the ICU stay up to 28 days are reported as Swiss francs
1 secondary outcome
Use of enteral nutrition
Time frame: day 28
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 14 Aug 2013.
- Derived from this study: PubMed 27222461Heidegger CP, Graf S, Perneger T, Genton L, Oshima T, Pichard C. The burden of diarrhea in the intensive care unit (ICU-BD). A survey and observational study of the caregivers' opinions and workload. Int J Nurs Stud. 2016 Jul;59:163-8. doi: 10.1016/j.ijnurstu.2016.04.005. Epub 2016 Apr 20.
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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.
Claude Pichard, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutrition in people with Critical Illness, run by University Hospital, Geneva 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 1 inclusion and 1 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 14 Aug 2013. 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. 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?
Cost of diarrhea (time frame: day 28). 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 NCT01922570, 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 14 Aug 2013.