Prescription Pattern of Adjuvant Drugs and Vitamins in Patients Undergoing Long-term Home Nutritional Support for Intestinal Insufficiency
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Purpose
Intestinal insufficiency due to short bowel syndrome is a chronic, disabling condition with significant morbidity and mortality.Standard care includes home parenteral/enteral nutrition as well as intestinal transplantation, however multiple drugs, vitamins, antibiotics and symptom-relieving agents may be required. Prescriptional pattern of these drugs will be analyzed in a clinical cohort.
| Condition | Intervention |
|---|---|
|
Intestinal Insufficiency Short Bowel Syndrome |
Drug: Drug prescription pattern |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Prescription Pattern of Adjuvant Drugs and Vitamins in Patients Undergoing Long-term Home Nutritional Support for Intestinal Insufficiency |
- Major gastrointestinal adjuvant prescription [ Time Frame: Last 12 months ] [ Designated as safety issue: No ]The most prescribed adjuvant agent for alleviation of gastrointestinal troubles such as diarrhea, malabsorption or gastric hypersecretion.
- Major antibiotic adjuvant prescription [ Time Frame: Last 12 months ] [ Designated as safety issue: No ]Principal antibiotic employed for suspected or actual bacterial overgrowth associated with diarrhea, malabsorption or systemic aberrations.
- Main vitamin/mineral adjuvant prescription [ Time Frame: Last 12 months ] [ Designated as safety issue: No ]Vitamin, mineral or other micronutrient required for correction of nutrition deficiency, not available or poorly absorbed via current parenteral/enteral nutrition regimen
| Enrollment: | 37 |
| Study Start Date: | September 2012 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Intestinal insufficiency
Patients with variable categories of major intestinal resection due to benign diseases,suffering from intestinal insufficiency and maintained with home nutritional support. Only clinically stable and nonhospitalized subjects will be recruited.
|
Drug: Drug prescription pattern
Type, dosage, administration route and frequency of prescription of all adjuvant pharmacologic agents will be transcribed from hospital records
Other Names:
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Detailed Description:
Intestinal insufficiency due to short bowel syndrome is a chronic, disabling condition with significant morbidity and mortality.Standard care includes home parenteral/enteral nutrition as well as intestinal transplantation, however multiple drugs, vitamins, antibiotics and symptom-relieving agents may be required. Little attention has been given to the indications and dosage schedules of such drugs, many of which are employed as off-label prescriptions because of lack of official guidelines.
Prescriptional patterns of these drugs will be analyzed in a clinical cohort of home parenteral/enteral nutrition patients, registered at the outpatient service of Hospital das Clinicas, Sao Paulo, Brazil.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Adults with short bowel syndrome secondary to trauma, Crohn´s disease, mesenteric thrombosis, radiation enteritis and other conditions, suffering from intestinal insufficiency and undergoing home-parenteral or enteral nutrition.
Inclusion Criteria: Home nutritional support longer than 12 months,full records and return visits available at the hospital system.
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Exclusion Criteria: Critical illness, death, discontinuation of nutritional therapy, registered for intestinal transplantation, additional gastrointestinal operations for short bowel syndrome (valves, lengthening) or for other conditions (gallbladder disease, intestinal obstruction, necrosis, infection).
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Contacts and Locations| Brazil | |
| Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077 | |
| Sao Paulo, Brazil, 05403900 | |
| Principal Investigator: | Bruna Z Godoy, RPh | University of Sao Paulo |
More Information
Additional Information:
Publications:
| Responsible Party: | Joel Faintuch, Associate Professor, Department of Gastroenterology, Sao Paulo University Medical School, University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT01696656 History of Changes |
| Other Study ID Numbers: | Gutadjuvant1, 0540/11 |
| Study First Received: | September 27, 2012 |
| Last Updated: | September 28, 2012 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by University of Sao Paulo:
|
Gastrointestinal drugs Antibiotics Vitamins Minerals Intestinal insufficiency |
Short Bowel syndrome Adjuvant therapy Antacids Gastrointestinal motility modifiers Micronutrients |
Additional relevant MeSH terms:
|
Short Bowel Syndrome Malabsorption Syndromes Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Postoperative Complications Pathologic Processes Adjuvants, Immunologic Anti-Bacterial Agents |
Gastrointestinal Agents Vitamins Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 23, 2013