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

NCT06164301 | Completed DMC

• 1 other identifier: FMASU R290/2023
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Malnutrition in Pregnancy; Malnutrition; Protein; Postpartum Disorder; Patient Satisfaction; Critical Illness

Keywords

critical illness; nutrition therapy; Enhanced Recovery After Surgery; Enhanced Recovery After Caesarean section

Outcome Measures

Primary Outcomes (2)

• the protein intake

  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

  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 Outcomes (1)

• satisfaction and Patient reported outcome measures (PROMs) regarding recovery aspects (physical comfort- emotional state, physical independence and pain

  After 48 hours or at discharge from ICU which comes first

Study Arms (2)

peptide-based semi-elemental formula group

EXPERIMENTAL

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

standard

ACTIVE COMPARATOR

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

Interventions

Elemental amino-acids DIETARY_SUPPLEMENT

mono peptide oral protein formula

peptide-based semi-elemental formula group; standard

Eligibility Criteria

• Age: 16 Years - 50 Years
• Gender Eligibility Details: pregnant female for cesarean section
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Cairo Governorate, Egypt

Location

Related Publications (3)

• Macones GA, Caughey AB, Wood SL, Wrench IJ, Huang J, Norman M, Pettersson K, Fawcett WJ, Shalabi MM, Metcalfe A, Gramlich L, Nelson G, Wilson RD. Guidelines for postoperative care in cesarean delivery: Enhanced Recovery After Surgery (ERAS) Society recommendations (part 3). Am J Obstet Gynecol. 2019 Sep;221(3):247.e1-247.e9. doi: 10.1016/j.ajog.2019.04.012. Epub 2019 Apr 14.

  PMID: 30995461 BACKGROUND

• Looijaard WGPM, Denneman N, Broens B, Girbes ARJ, Weijs PJM, Oudemans-van Straaten HM. Achieving protein targets without energy overfeeding in critically ill patients: A prospective feasibility study. Clin Nutr. 2019 Dec;38(6):2623-2631. doi: 10.1016/j.clnu.2018.11.012. Epub 2018 Dec 17.

  PMID: 30595377 BACKGROUND

• Meyer R, Foong RX, Thapar N, Kritas S, Shah N. Systematic review of the impact of feed protein type and degree of hydrolysis on gastric emptying in children. BMC Gastroenterol. 2015 Oct 15;15:137. doi: 10.1186/s12876-015-0369-0.

  PMID: 26472544 BACKGROUND

MeSH Terms

Conditions

Kwashiorkor; Puerperal Disorders; Patient Satisfaction; Critical Illness

Condition Hierarchy (Ancestors)

Severe Acute Malnutrition; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• wessam selima, MD

  assistant professor (lecturer)- Ain shams university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be assigned into either; A)intervention 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 ) , Second day ordinary food will be supplemented by half the dose of the first day from the semi-elemental protein (250 ml / 6 hours ) or to the dose to achieve the daily protein adequacy 1.3 mg/kg/day. B) The standard group will be NPO till the return of bowel functions.

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 11, 2023
• Study Start: April 14, 2024
• Primary Completion: January 20, 2026
• Study Completion: March 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)