Malnutrition Clinical Trial
Official title:
Preoperative PN Therapy in Malnourished Patients With IBD - A Randomized Controlled Trial
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.
Primary Objective 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.
Secondary Objectives 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 Primary Endpoint The primary endpoints will be the
incidence of post-surgical complications in malnourished patients receiving pre-operative PN
therapy compared with standard of care therapy Secondary Endpoints The secondary endpoints
will be the cumulative incidence of post-operative infectious complications in IBD patients
receiving surgery and hospital length of stay in patients receiving pre-operative PN therapy
compared to standard of care nutritional therapy METHODS Study Design This is a prospective
multi-center randomized controlled study. Allocation to either intervention or control group
will be randomized based on blocks system (size of 4). The randomization sequence will be
computer generated. Conjoint Ethics Review Board Approval for the study protocol will be
sought in conventional manner.
Withdrawal Criteria
(a) If there is any catheter - related complications (including infection) resulting in
catheter removal; (b) If the patient does not meet the goal therapeutic PN rate; (c) If the
duration between the PN initiation and the surgery is less than 7 days (e.g. if the patient
needed an emergency surgical intervention)
Recruitment and Consent The overwhelming majority of patients with IBD are admitted to the
Gastroenterology Inpatient Service. As such, recruitment to this study will take a
multi-pronged approach and be stream-lined. All Gastroenterologists and Gastroenterology (GI)
Fellows in training at the FMC and PLC will be made aware of the protocol and as they are
rounding, they will be aware to ask any eligible patients if they would be willing to speak
with our research assistant about study participation. In addition, the research coordinator
assigned to the study will review the inpatient electronic medical record, Sunrise Clinical
Manager (SCM) daily to identify newly admitted inpatients to both study sites with IBD. The
research coordinator will review the study eligibility of the newly admitted inpatients with
the GI Fellows rotating on the GI service, and approach patients for protocol review and
consent once deemed eligible. All participants will undergo prospective consenting via a
written informed consent either by themselves or their family members.
Study Intervention Experimental Group Participants assigned to the experimental group will
commence PN therapy delivered through central venous catheter (CVC) access within 24-48 hours
of admission. For the study, Olimel will be used as the PN formulation of choice.
Specifically, Olimel 5.7% with electrolytes will be the preferred study product. CVC access
is readily obtained at the FMC and PLC within this duration through a central venous access
team designated team for this purpose. A registered dietitian (RD) will be specifically
recruited for this study and will prescribe PN for eligible patients based on individualized
nutritional assessment. Eligible patients will be malnourished by definition, resulting in
conservative initial PN dosing to minimize the risk of refeeding syndrome . The study RD will
calculate energy requirements based on predictive equations, such as the Harris Benedict
Equation to determine target goals. The target protein and calorie requirements will be met
within 48-72 hours of PN initiation. The optimal duration of delivery of PN preoperatively
was defined by Klein et al , supported by an earlier meta-analysis by Detsky et al. The Klein
meta-analysis of 14 prospective randomized trials showed a consistent benefit from
preoperative PN, showing a 10% reduction in overall postoperative complications. Thirteen of
14 studies in this meta-analysis provided PN for at least 7 days , leading the Klein
suggestions that use of PN should not be considered unless the duration of therapy was
anticipated to be a minimum of 7 days. In accordance, PN will be administered for a minimum
of 7-days prior to surgery.
Control Group Participants assigned to the control group will receive standard of care (SOC)
nutritional therapy. Control group patients will be assessed by the RD assigned to the
medical unit to which the patient has been admitted (independent RD assessment). The unit RD
will follow standard nutrition screening processes to determine nutrition risk, followed by a
complete nutrition assessment in the presence of nutrition risk. Conventionally, patients
will complete calorie counts with clinical observation by the unit RD, with nutrition
support, typically enteral nutrition recommended when oral intake is inadequate. Failure of
EN to meet goal calorie intake may result in PN therapy at the discretion of the unit RD and
treating team.
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