Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01922570 |
| Other study ID # |
NAC 07-098 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
June 24, 2013 |
| Last updated |
August 11, 2013 |
| Start date |
January 2012 |
| Est. completion date |
April 2013 |
Study information
| Verified date |
August 2013 |
| Source |
University Hospital, Geneva |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Switzerland: Swissmedic |
| Study type |
Interventional
|
Clinical 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. 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.
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
1. 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
2. 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
3. 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
4. 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
5. 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
6. 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
7. 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
8. 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
9. 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
