Enterocutaneous Fistulas Clinical Trial
— VITACOfficial title:
Effectiveness of Doses of Vitamin c and Zinc in Patients With High Enterocutaneous Fistulas Receiving Nutrition Parenteral Therapy on Closure and Recurrence. Randomized Clinical Trial.
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.
Status | Recruiting |
Enrollment | 76 |
Est. completion date | December 31, 2028 |
Est. primary completion date | December 31, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital Juárez de México | Ciudad de México | Cdmx |
Lead Sponsor | Collaborator |
---|---|
Hospital Juarez de Mexico |
Mexico,
Couper C, Doriot A, Siddiqui MTR, Steiger E. Nutrition Management of the High-Output Fistulae. Nutr Clin Pract. 2021 Apr;36(2):282-296. doi: 10.1002/ncp.10608. Epub 2020 Dec 24. — View Citation
Girard E, Messager M, Sauvanet A, Benoist S, Piessen G, Mabrut JY, Mariette C. Anastomotic leakage after gastrointestinal surgery: diagnosis and management. J Visc Surg. 2014 Dec;151(6):441-50. doi: 10.1016/j.jviscsurg.2014.10.004. Epub 2014 Oct 22. — View Citation
Jeejeebhoy K. Zinc: an essential trace element for parenteral nutrition. Gastroenterology. 2009 Nov;137(5 Suppl):S7-12. doi: 10.1053/j.gastro.2009.08.014. — View Citation
Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale R, Waitzberg DL, Bischoff SC, Singer P. ESPEN guideline: Clinical nutrition in surgery. Clin Nutr. 2017 Jun;36(3):623-650. doi: 10.1016/j.clnu.2017.02.013. Epub 2017 Mar 7. — View Citation
Yanase F, Fujii T, Naorungroj T, Belletti A, Luethi N, Carr AC, Young PJ, Bellomo R. Harm of IV High-Dose Vitamin C Therapy in Adult Patients: A Scoping Review. Crit Care Med. 2020 Jul;48(7):e620-e628. doi: 10.1097/CCM.0000000000004396. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fistula closure | Evaluate enterocutaneous fistula closure rate. | follow-up at 30 days | |
Primary | Recurrence of fistula | Evaluate the recurrence of enterocutaneous fistula | follow-up at 30 days | |
Secondary | Medical-nutritional status | Medical-nutritional status: subjective global assessment | 24-72 hours after hospital admission | |
Secondary | Medical-nutritional status | Medical-nutritional status: nutritional risk index | 24-72 hours after hospital admission | |
Secondary | biochemical markers | Changes in nutritional status biochemical markers: albumin in serum | every week until a maximum follow-up at 30 days | |
Secondary | biochemical markers | Changes in nutritional status biochemical markers: lymphocytes in serum. | every week until a maximum follow-up at 30 days | |
Secondary | biochemical markers | Changes in nutritional status biochemical markers: prealbumin in serum. | every week until a maximum follow-up at 30 days | |
Secondary | biochemical markers | Changes in nutritional status biochemical markers: transferrin in serum. | every week until a maximum follow-up at 30 days | |
Secondary | Metabolic profile | Changes in metabolic profile in serum glucose concentration | every week until a maximum follow-up at 30 days | |
Secondary | Metabolic profile | Changes in metabolic profile in serum tests liver | every 15 days up to a maximum follow-up at 30 days | |
Secondary | Length of hospital stay of patients | Determine the length of hospital stay of patients. | follow-up at 30 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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Molecular Characteristics of the Persistent Intestinal Fistulae After Glue Application
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N/A | |
Completed |
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Autologous Fibrin Glues for Fistulas Closure
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Phase 1 |