Enteral Nutrition in Acute Generalized Peritonitis (PAG/NUTRI)
Primary Purpose
Enteral and Supplement Feeds Adverse Reaction, Peritonitis; Acute
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
study group
Sponsored by
About this trial
This is an interventional supportive care trial for Enteral and Supplement Feeds Adverse Reaction
Eligibility Criteria
Inclusion Criteria: patient operated for peritonitis with intestinal suture during treatment have a q-SOFA score of 1 to 2 surgeon's agreement to enteral feeding at risk of malnutrition (BMC) Exclusion Criteria: q SOFA score > 2 patients with tare (diabetes, HIV, renal failure)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
study group
control group
Arm Description
an intervention arm consisting of patients who will receive the locally manufactured protein-energy ration after a laparotomy indicated for generalized acute peritonitis
patients who will receive the commercially available protein-energy ration after a laparotomy indicated for generalized acute peritonitis
Outcomes
Primary Outcome Measures
Tolerability of feeding
We will screen complications after feeding
Secondary Outcome Measures
nutritional surveillance
changes in nutritional status using body mass index, albumin measurement, anthropometric data
Full Information
NCT ID
NCT05997745
First Posted
August 7, 2023
Last Updated
August 11, 2023
Sponsor
Université Evangélique enAfrique
1. Study Identification
Unique Protocol Identification Number
NCT05997745
Brief Title
Enteral Nutrition in Acute Generalized Peritonitis
Acronym
PAG/NUTRI
Official Title
Effects of Early Enteral Nutrition With a Locally Produced Protein-energy Ration Versus a Marketed Nutritional Solution in Patients Operated on for Acute Generalized Peritonitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 20, 2023 (Anticipated)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université Evangélique enAfrique
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Hospitals in South Kivu always have problems supplying artificial enteral nutritional products because of their high cost and low availability in our areas. While the Province has cereals, knowing their nutritional composition would enable the formulation of a nutritional product based on local protein-energy products. Hence the questions below: Can a local cereal-based protein-energy ration be used instead of a costly imported artificial nutritional solution to improve the nutritional status of patients operated on for PAG? What is the tolerance of this early enteral nutrition on the healing and functional recovery of patients compared with an artificial nutritional solution? To answer these questions, a randomized clinical trial has been designed with the following objectives:
To formulate an enteral diet using cereals available in our environment with a protein-calorie composition superimposable on the artificial enteral ration,
Evaluate the tolerance and advantages of early enteral nutrition with a locally manufactured protein-caloric ration vs. a commercially available artificial nutritional solution in patients undergoing surgery for PAG.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enteral and Supplement Feeds Adverse Reaction, Peritonitis; Acute
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
an intervention arm consisting of patients who will receive the locally manufactured protein-energy ration after a laparotomy indicated for generalized acute peritonitis
Arm Title
control group
Arm Type
Active Comparator
Arm Description
patients who will receive the commercially available protein-energy ration after a laparotomy indicated for generalized acute peritonitis
Intervention Type
Dietary Supplement
Intervention Name(s)
study group
Intervention Description
Patients will receive early enteral locally nutrition postoperatively following surgery for peritonitis
Primary Outcome Measure Information:
Title
Tolerability of feeding
Description
We will screen complications after feeding
Time Frame
10 days after surgery
Secondary Outcome Measure Information:
Title
nutritional surveillance
Description
changes in nutritional status using body mass index, albumin measurement, anthropometric data
Time Frame
2 days after, 5 days after, 10 days after feeding
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient operated for peritonitis with intestinal suture during treatment
have a q-SOFA score of 1 to 2
surgeon's agreement to enteral feeding
at risk of malnutrition (BMC)
Exclusion Criteria:
q SOFA score > 2
patients with tare (diabetes, HIV, renal failure)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JEAN PAUL CIKWANINE, MASTER
Phone
+243990860491
Email
jpcikwa1@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Enteral Nutrition in Acute Generalized Peritonitis
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