Value of Early Post Operative Amino Acids in Critically Ill Obstetrics on Recovery Enhancement

Critical Illness Clinical Trial

Official title:

the Value of Early Post-operative Elemental Amino Acids in Critically Ill Obstetrics, and Its Contribution to the Concept of ERAS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06164301
• Other study ID #: FMASU R290/2023
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: April 2024
• Source: Ain Shams University
• Contact: wessam selima, MD
• Phone: +201001958858
• Email: w.z.selima[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is the first trial to assess the early elemental postoperative amino-acid 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)

Description:

The objective is to measure the effect of elemental amino acids in 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 obstetrics ICU. where degree of severity of the condition will be assessed and the relevant protocol of treatment will be started , all cases will be nutritional assessed using m-NUTRIC of critically ill patients 10. 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 Base line laboratory indices will be withdrawn including; CBC, Metabolic profile, liver function profile, renal function profile, ABG, INR.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)Elemental Amino group ; post-operative within the first 3 hours the patient will receive 250 ml of 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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

• Uncontrolled diabetic condition.

Related Conditions & MeSH terms

• Critical Illness
• Kwashiorkor
• Malnutrition
• Malnutrition in Pregnancy
• Malnutrition; Protein
• Patient Satisfaction
• Postpartum Disorder
• Puerperal Disorders

Intervention

Dietary Supplement:
• Elemental amino-acids
mono peptide oral protein formula

Locations

Country	Name	City	State
Egypt	Ain shams university	Cairo	???????

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the caloric intake	total caloric intake/day measurement tool is calculation based on the food intake documents , and measured by kcal/kg/day	postoperative (48 hours)
Primary	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	postoperative (48 hours)
Secondary	satisfaction of the patients regarding recovery aspects (physical comfort- emotional state, physical independence and pain	will be assessed using Obstetric Quality of Recovery-11 survey tool and measured by units on the scale , it is 11 questions with answers on scale from 0 to 10 where 0 =very poor and 10 = excellent.	on discharge from ICU