Enteral Nutrition in Acute Generalized Peritonitis (PAG/NUTRI)

August 11, 2023 updated by: Université Evangélique enAfrique

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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Dietary supplement: study group
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
Dietary supplement: study group
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

This is where you will find people and organizations involved with this study.

Sponsor

Université Evangélique enAfrique

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 20, 2023

Primary Completion (Estimated)

October 30, 2023

Study Completion (Estimated)

October 30, 2023

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

August 11, 2023

First Posted (Actual)

August 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

July 1, 2023

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

No

Studies a U.S. FDA-regulated device product

No

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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