Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06009744
Other study ID # HJM 005/32-I
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 2023
Est. completion date December 31, 2028

Study information

Verified date August 2023
Source Hospital Juarez de Mexico
Contact Elizabeth Pérez Cruz
Phone 525557477560
Email pece_liz@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Low-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
High-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

Locations

Country Name City State
Mexico Hospital Juárez de México Ciudad de México Cdmx

Sponsors (1)

Lead Sponsor Collaborator
Hospital Juarez de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (5)

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

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT01990833 - Molecular Characteristics of the Persistent Intestinal Fistulae After Glue Application N/A
Completed NCT01561066 - Autologous Fibrin Glues for Fistulas Closure Phase 1