Critically Ill
Conditions
Keywords
adults
Brief summary
The aim of this study is to compare two nutritional regimes in critically ill patients. Patients will be randomized to standard care (25 kcal per kg) or to hypocaloric nutrition (15 kcal per kg). The main outcome will be the SOFA (sequential organ failure assessment) score. The hypothesis is that hypocaloric hyperproteic diet decreases the incidence of organic failure in these patients.
Detailed description
The research site will be the intensive care unit (ICU) of Hospital Universitario San Ignacio; eligible patients will \>18 years of age with a presumed fasting period of at least 96 hours, with no contraindications for enteral nutrition. Patients with parenteral nutrition, pregnancy, diabetes, liver failure, renal failure, transplant protocol, or admitted from another hospital will be excluded. In all patients, the following information will be collected daily: enteral formula in ml, carbohydrate intake, insulin required (in IU), presence of hyper or hypoglicemia, presence of infections, among others. The SOFA score will be assessed every two days until discharge from ICU.
Interventions
DIETARY_SUPPLEMENTHypocaloric hyperproteic nutrition
15 kcal per kg of body weight and 1.7 grams of protein per kg.
DIETARY_SUPPLEMENTStandard care
25 kcal per kg of body weight
Sponsors
Hospital Universitario San Ignacio
Lafrancol S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>18 years * estimated fasting period of at least 96 hours
Exclusion criteria
* parenteral nutrition * pregnancy * diabetes * liver or renal failure * transplantation * admitted from another hospital
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SOFA (Sequential Organ Failure Assessment) Score | 48 hours since nutritional regime starts | SOFA score evaluates six systems: respiratory, cardiovascular, coagulation, Central Nervous System, liver and renal. Each system gets a score from 0 (normal) to 4 (abnormal) and the sum of each score defines the final SOFA score, which 24 is the maximum score (high risk of morality) and 0 is the minimum score (low risk of mortality). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Requirements | Daily until day 21 or discharge from ICU | This is an indirect measure of glycemic control, and is reported as a daily average. |
Countries
Colombia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Care Patients will receive normal nutritional regime of around 25 kcal per kg.
Standard care: 25 kcal per kg of body weight | 40 |
| Hypocaloric Hyperproteic Nutrition 15 kcal per kg of body weight and 1.7 grams of protein per kg
Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg. | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Standard Care | Hypocaloric Hyperproteic Nutrition | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 40 Participants | 80 Participants |
| Age, Continuous | 55.7 years STANDARD_DEVIATION 19.5 | 53.3 years STANDARD_DEVIATION 19.5 | 54.5 years STANDARD_DEVIATION 19.5 |
| Region of Enrollment Colombia | 40 participants | 40 participants | 80 participants |
| Sex: Female, Male Female | 16 Participants | 18 Participants | 34 Participants |
| Sex: Female, Male Male | 24 Participants | 22 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
SOFA (Sequential Organ Failure Assessment) Score
SOFA score evaluates six systems: respiratory, cardiovascular, coagulation, Central Nervous System, liver and renal. Each system gets a score from 0 (normal) to 4 (abnormal) and the sum of each score defines the final SOFA score, which 24 is the maximum score (high risk of morality) and 0 is the minimum score (low risk of mortality).
Time frame: 48 hours since nutritional regime starts
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | SOFA (Sequential Organ Failure Assessment) Score | 0.7 units on a scale | Standard Deviation 2.8 |
| Hypocaloric Hyperproteic Nutrition | SOFA (Sequential Organ Failure Assessment) Score | 1.7 units on a scale | Standard Deviation 1.9 |
Secondary
Insulin Requirements
This is an indirect measure of glycemic control, and is reported as a daily average.
Time frame: Daily until day 21 or discharge from ICU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Insulin Requirements | 14 International Unit of insulin | Standard Deviation 22.1 |
| Hypocaloric Hyperproteic Nutrition | Insulin Requirements | 10.4 International Unit of insulin | Standard Deviation 17.8 |