Enterocutaneous Fistulas
Conditions
Keywords
enterocutaneous fistulas, Vitamin C, Zinc, Parenteral nutrition
Brief summary
Various micronutrients play an important role in the process of closure and recurrence of enterocutaneous fistulas, such as Vitamin C and Zinc. However, there is no specific recommendation on the dose of these nutrients by parenteral route.
Detailed description
This is a randomized, control trial to investigate the effect and safety of doses of vitamin c and zinc in patients with high enterocutaneous fistulas receiving who need nutrition parenteral therapy on closure and recurrence. Screening will be made to select eligible participants before intervention. Participants were randomly assigned to one of two groups: group a) 25-35 kcal/K/d, 1.3-1.5 g/K/d of amino acids and C 100-300 mg/d y zinc 3-5 mg/d; group b) 25-35 kcal/K/d, 1.3-1.5 g/K/d of amino acids and Vitamin C 1000-2000 mg/d y zinc 10-15 mg/d. Demographic variables and subjective global assessment scale will be recorded and applied. Anthropometric measurements (weight and body mass index) will be evaluated upon admission and weekly until hospital discharge. Biochemical markers (albumin, lymphocytes, prealbumin, transferrin, cholesterol, creatinine) and serum metabolic profile (glucose, liver function test) will be measured weekly. During hospitalization, patients will be evaluated daily until the closure of the fistula and/or follow-up at 30 days, monitoring capillary blood glucose, insulin expenditure, and fistula volume.
Interventions
DRUGLow-dose vitamin C and zinc
This is a randomized, control trial to investigate the effect of Vitamin C and Zinc in patients with enterocutaneous fistulas receiving nutrition parenteral therapy and Vitamin C 100-300 mg/d and zinc 3-5 mg/d
DRUGHigh-dose vitamin C and zinc
This is a randomized, control trial to investigate the effect of Vitamin C and Zinc in patients with enterocutaneous fistulas receiving nutrition parenteral therapy and Vitamin C 1000-2000 mg/d y zinc 10-15 mg/d
Sponsors
Hospital Juarez de Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Group a) 25-35 kcal/K/d, 1.3-1.5 g/K/d of amino acids and C 100-300 mg/d y zinc 3-5 mg/d Group b) 25-35 kcal/K/d, 1.3-1.5 g/K/d of amino acids and Vitamin C 1000-2000 mg/d y zinc 10-15 mg/d.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Women and men * \>18 years and \<70 years old. * Diagnosis of high-output enterocutaneous fistula for the first time * Need for parenteral nutrition
Exclusion criteria
* Octreotide use * Palliative care * Steroid use * Oxalate nephropathy * G6PD deficiency * Hemochromatosis * Abdominal surgeries in the last 6 months * Hospitalizations for more than 15 days in the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fistula closure | follow-up at 30 days | Evaluate enterocutaneous fistula closure rate. |
| Recurrence of fistula | follow-up at 30 days | Evaluate the recurrence of enterocutaneous fistula |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medical-nutritional status | 24-72 hours after hospital admission | Medical-nutritional status: subjective global assessment |
| biochemical markers | every week until a maximum follow-up at 30 days | Changes in nutritional status biochemical markers: albumin in serum |
| Metabolic profile | every week until a maximum follow-up at 30 days | Changes in metabolic profile in serum glucose concentration |
| Length of hospital stay of patients | follow-up at 30 days | Determine the length of hospital stay of patients. |
Countries
Mexico
Contacts
Primary ContactElizabeth Pérez Cruz
Backup ContactSalvador Ortiz Gutiérrez
Outcome results
None listed