Value of Early Postoperative Peptide-based Formula in Critically Ill Obstetrics on Recovery Enhancement

March 9, 2026 updated by: Ain Shams University

The Value of Early Postoperative Peptide-based, Semi-elemental Enteral Formulation in Critically Ill Obstetric Patients Within an ERAS Framework: a Pragmatic Randomized Controlled Trial

This is the first trial to assess the early semi-elemental postoperative formula load to meet the protein requirements in the first and second day postoperative to enhance the recovery of critically ill parturient (value on ERAS of critically ill obstetrics)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective is to measure the effect of peptide-based semi-elemental formula in the early post-operative period on reaching protein adequacy as well as energy intakes, gut function, clinical outcomes, and the quality of recovery.

All candidates will be assessed thoroughly by history and examination, and informed consent will be taken. All patients will be admitted to the obstetrics ICU. where degree of severity of the condition will be assessed and the relevant protocol of treatment will be started. All patients will receive the treatment algorithm of critically ill as follow; Prophylactic anticoagulation (Enoxaparin 40 mg once daily) when appropriate after surgeon consultation. Antibiotic as policy, Proton pump inhibitors (omeprazole 40 mg once daily), Other supportive medication according to the needs of the condition, For postoperative pain routine care in the form of use of paracetamol (10mg/kg/8 hrs), and non-steroidal anti-inflammatory(ketorolac 30 mg /12 hrs ) medication and nalbuphine will be used till comfort of the patient. All doses will be adjusted according to body weight and organ function when required. Base line laboratory indices will be withdrawn including; CBC, Metabolic profile, liver function profile, renal function profile, ABG, INR.

The eligible patients will be randomly assigned into one of two groups through the random numbers, the random numbers will be used by a pharmacist who will prepare the different regimen. the data collector will be blind about the grouping intervention. A)intervention group ; post-operative within the first 3 hours the patient will receive 250 ml of peptide-based, semi-elemental protein( 250 ml Peptamen = 6 scoops (55g) + 210ml water ) repeated at ( 6, 8 , 10 , 12 hours postoperative ) in order to reach total protein in order to reach total protein 50 mg in the first 12 hour post-operative, Second day ordinary food will be introduced supplemented by half the dose of the first day from elemental protein (250 ml / 6 hours ) or to the dose to achieve the daily protein adequacy 1.3 mg/kg/day. B) Standard group; The patients in this group will receive the standard protocol in which they will be made NPO till the return of bowel functions. Thereafter, water and clear fluids will be given followed by soft food and, eventually a regular diet. Protein requirement in postpartum around 1g/kg reaching up to 1.9 gm/kg 11. The investigator will standardize the intake to 1.3g/kg.

In both groups intravenous fluid will be given according to hemodynamic in the form of ringer acetate with basal infusion 40ml/hr and will be adjusted according to hemodynamic parameters. In both groups, daily food and fluid record will be assessed by research assistant who will follow both the patient recall and the nurse record. The research assistant will be provided by written details in how to calculate protein and energy intake.

Study Type

Interventional

Enrollment (Actual)

83

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 Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt
        • Ain Shams University

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Critically ill Female patients with cesarean section with or without hysterectomy that requires ICU admission pre or postoperative

Exclusion Criteria:

  • Decompensated heart failure,
  • Known allergy
  • Tryptophan intolerance
  • known inborn errors of metabolism of proteins as alkaptonuria
  • severe hepatic dysfunction (failure)
  • severe renal dysfunction (failure)
  • severe coagulopathy or DIC
  • circulatory shock or hemodynamic instability
  • Lactose intolerance
  • G6PD deficiency

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard
Standard group; The patients in this group will receive the standard protocol in which they will be made NPO till the return of bowel functions. Thereafter, water and clear fluids will be given followed by soft food and, eventually a regular diet.
Dietary supplement: Elemental amino-acids
mono peptide oral protein formula
Experimental: peptide-based semi-elemental formula group
peptide-based, semi-elemental group ; post-operative within the first 3 hours the patient will receive 250 ml of semi-elemental protein( 250 ml Peptamen = 6 scoops (55g) + 210ml water ) repeated at ( 6, 8 , 10 , 12 hours postoperative ) in order to reach total protein in order to reach total protein 50 mg in the first 12 hour post-operative, Second day ordinary food will be introduced supplemented by half the dose of the first day from semi-elemental protein (250 ml / 6 hours ) or to the dose to achieve the daily protein adequacy 1.3 mg/kg/day.
Dietary supplement: Elemental amino-acids
mono peptide oral protein formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the protein intake
Time Frame: 24 hours postoperative. If the patient stay extended more than a day, the intake of second 24 hours will be calculated,
total protein intake/day measurement tool is calculation based on protein content in the food intake list , and measured by gram/kg/day
24 hours postoperative. If the patient stay extended more than a day, the intake of second 24 hours will be calculated,
The energy intake
Time Frame: 24 hours postoperative. If the patient stay extended more than a day, the intake of second 24 hours will be calculated
total energy intake/day, The measurement tool is calculated by an experienced clinical nutrition pharmacist based on food and supplements intake in nursing records and patient recall, and measured by kcal/kg/day
24 hours postoperative. If the patient stay extended more than a day, the intake of second 24 hours will be calculated

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
satisfaction and Patient reported outcome measures (PROMs) regarding recovery aspects (physical comfort- emotional state, physical independence and pain
Time Frame: After 48 hours or at discharge from ICU which comes first
will be assessed using the Obstetric Quality of Recovery-10A survey tool and measured by units on the scale, it is 10 questions with answers on a scale from 0 to 10 where 0 =very poor and 10 = excellent. with cumulative score where <71= poor, 71-88= moderate, >88= excellent.
After 48 hours or at discharge from ICU which comes first

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: wessam selima, MD, assistant professor (lecturer)- Ain shams university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

April 14, 2024

Primary Completion (Actual)

January 20, 2026

Study Completion (Actual)

March 1, 2026

Study Registration Dates

First Submitted

November 21, 2023

First Submitted That Met QC Criteria

December 1, 2023

First Posted (Actual)

December 11, 2023

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU R290/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data will be shared on reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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