- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05997745
Enteral Nutrition in Acute Generalized Peritonitis (PAG/NUTRI)
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
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: JEAN PAUL CIKWANINE, MASTER
- Phone Number: +243990860491
- Email: jpcikwa1@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: study group
an intervention arm consisting of patients who will receive the locally manufactured protein-energy ration after a laparotomy indicated for generalized acute peritonitis
|
Patients will receive early enteral locally nutrition postoperatively following surgery for peritonitis
|
Active Comparator: control group
patients who will receive the commercially available protein-energy ration after a laparotomy indicated for generalized acute peritonitis
|
Patients will receive early enteral locally nutrition postoperatively following surgery for peritonitis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tolerability of feeding
Time Frame: 10 days after surgery
|
We will screen complications after feeding
|
10 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
nutritional surveillance
Time Frame: 2 days after, 5 days after, 10 days after feeding
|
changes in nutritional status using body mass index, albumin measurement, anthropometric data
|
2 days after, 5 days after, 10 days after feeding
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 002 (University of CT Health Center)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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