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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- the protein intake
研究概览
简要总结
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)
详细描述
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 Base line laboratory indices will be withdrawn including; CBC, Metabolic profile, liver function profile, renal function profile, ABG, INR.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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Critically ill Female patients with cesarean section with or without hysterectomy that requires ICU admission pre or postoperative
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Elemental amino-acids (Dietary Supplement)
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.
干预措施: Elemental amino-acids (Dietary Supplement)
结局指标
主要结局
the protein intake
时间窗: 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
The energy intake
时间窗: 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
次要结局
- 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)