Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2025-12-24 @ 12:32 PM
NCT ID:
NCT00396461
Eligibility Criteria:
INCLUSION CRITERIA:
Patients of both sexes, prospective admission to Intensive Care Units (ICUs), over 18 years, where TPN is required as a nutritional metabolic support for a minimum period of 5 days and where said patients have signed the informed consent form.
The indications for administration of parenteral nutrition shall be those recommended by the American Society of Parenteral and Enteral Nutrition (ASPEN), and in particular:
* Severe malnutrition
* Major intra-abdominal surgery
* Peritonitis
* Intestinal ischaemia
* Intestinal occlusion
* Gastrointestinal fistulas
* Small intestine
Patients of both sexes, over 18 years, that commencing nutritional support with enteral diets in the first 3 days of admission to ICU require parenteral nutrition as:
* 75% of the calculated energy requirements have not been reached after three days receiving enteral nutrition.
* Gastrointestinal complications have been suffered as a result of enteral nutrition that cannot be treated or are persistent in the first 3 days of admission.
In this case EN will be suspended and the patient will be included in the protocol receiving PN.
EXCLUSION CRITERIA:
* APACHE II \< 13
* Morbid obesity (BMI ≥ 39)
* Hepatic disease defined within the following set of parameters:
1. Portal hypertension with gastrointestinal bleeding on admission
2. Clinically apparent hepatocellular ascites
3. Hepatocellular bilirubin higher than 3 mg/dL
4. Serum albumin less than 30 g/L with portal hypertension
5. Grade II or higher encephalopathy
6. Clinical diagnosis of alcoholic hepatitis
* Chronic renal insufficiency defined by one of the following criteria:
1. Plasmatic creatinine greater than 4 mg/dL
2. Chronic peritoneal dialysis or haemodialysis
* Patients with severe acquired or familial hyperlipidaemias (\> 400 mg/day) of any kind
* Serious chronic neurological disease defined by one of the following criteria:
1. Cerebrovascular accident with persistent neurological deficit in the past six months
2. Neurological deficit that necessitates chronic confinement
* Neoplastic patients with metastasis and a life expectancy of less than six months
* Patients that underwent chemotherapy or radiotherapy during the month prior to the study
* Patients that received chronic treatment with corticoids in the month preceding admission to ICU. Patients receiving treatment with corticoids since admission to ICU for septic shock should not be excluded.
* Continuous infusion treatment for more than 24 hours with propofol or with other pharmaceuticals where lipid emulsions are used as the vehicle
* Infectious diseases transmitted through the blood, products derived from blood or urine: hepatitis B, C and HIV
* Inclusion in another clinical trial
* Having received TPN in the month prior to inclusion in the study
* Pregnancy
* Refusal to participate in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00396461
Study Brief:
Protocol Section:
NCT00396461