Malnutrition Clinical Trial
Official title:
Preoperative PN Therapy in Malnourished Patients With IBD - A Randomized Controlled Trial
Verified date | May 2018 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Malnourished patients with IBD that receive pre-operative parenteral nutrition therapy will have fewer post-operative complications compared to malnourished patients that receive standard of care nutritional therapy.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 1, 2018 |
Est. primary completion date | December 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - (a) Age > 18 years; - (b) Ability to provide informed consent; - (c) Documented diagnosis of IBD as confirmed in the patient chart; - (d) Malnourished status as defined by SGA B or C status; - (e)Referral to colorectal surgery for surgical assessment; - (f) No major contraindications to PN Exclusion Criteria: - (a) Active sepsis defined by positive blood cultures or fever > 38.5 within 48 hours of PN initiation; - (b)Well-nourished status defined as SGA-A; - (c) Inadequate vascular access; - (d) Advanced liver disease; - (e)Poorly controlled blood sugars |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incidence of post-surgical complications in malnourished patients receiving pre-operative PN therapy compared with standard of care therapy | To determine the impact of pre-operative PN therapy in malnourished patients with IBD compared with standard of care nutritional therapy on the development of total post-operative complications. | From date of randomization until the date of hospital discharge, assessed up to 6 months | |
Secondary | cumulative incidence of post-operative infectious complications in IBD patients receiving surgery | To assess the impact of pre-operative PN therapy in malnourished patients with IBD compared with standard of care nutritional therapy on the incidence of post-operative infectious complications | From date of randomization until the date of hospital discharge, assessed up to 6 months |
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