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临床试验/NCT02580214
NCT02580214已完成2 期

A Protocol Of Perioperative Care Plus Immunonutrition Enhances Recovery After Total Hip Arthroplasty. A Randomized Pilot Study

Federal University of Mato Grosso2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2013年5月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
32
试验地点
2
主要终点
Length of postoperative stay

研究概览

简要总结

The aim of this pilot study was to investigate whether the use of a multimodal protocol of preoperative care plus preoperative immune nutrition would decrease the length of stay and acute phase inflammation in patients submitted to total hip arthroplasty (THA). The study was designed to be randomized and controlled, but not double blind. The patients were randomized to receive either preoperative care based on evidence plus immune nutrition for 5 days prior to surgery (Acerto group) or traditional preoperative care (control group). Main endpoints were length of stay and acute-phase postoperative response

详细描述

A large broad of evidence has shown that traditional perioperative care have a weak scientific basis and needs to be changed. Multimodal or fast-track protocols of perioperative care for abdominal surgery have been associated with lower morbidity, lower costs and faster postoperative recovery when compared to traditional care . Similarly the prescription of perioperative immune nutrition for 5-7 days before major abdominal surgery may decrease the risk of infections and reduce postoperative length of stay (LOS). Interestingly there is lack of studies on multimodal protocols of enhanced recovery and on immune nutrition in elective total hip arthroplasty (THA). In Brazil, the ACERTO (an acronym in Portuguese for acceleration of postoperative recovery) protocol is a multimodal protocol of perioperative care that includes: shortening of preoperative fasting with carbohydrates (CHO)-rich drinks up to 2h before surgery, restriction of intravenous fluids and early postoperative re-feeding and mobilization. Recently as a dynamic protocol the Acerto protocol included the recommendation of perioperative immune nutrition. All the elements of the protocol are based on evidence and are recommended by various international guidelines and consensus. Thus, the aim of this pilot study was to investigate whether the use of the Acerto multimodal protocol plus preoperative immune nutrition would decrease the length of stay and acute phase inflammation in patients submitted to THA.

METHODS This was a prospective randomized pilot study. All procedures were performed at São Mateus Hospital (Cuiabá, Brazil) from May 2012 to February 2013. The study was approved by the Research Ethics Committee of the Júlio Müller University Hospital (Federal University of Mato Grosso) and all patients signed a term of informed consent.

Inclusion and exclusion criteria. The investigators included adult patients of both sex having a hip osteoarthrosis and candidates of elective THA. Patients were excluded if they had fasting glycemia greater than 200mg/dl; acquired immunodeficiency (AIDS); renal failure (creatinin above 2 mg/dl); cirrhosis; moderate or serious Alzheimer's disease (clinical dementia rating score between 2 and 3); an American Society of Anesthesiologists (ASA) score higher than 2; previous spinal surgery (arthrodesis) or THA (reviewing or changing the prosthetic); and severe malnutrition (history of loss of 10% of body weight over the last 6 months). The investigators also excluded patients who did not have their blood samples taken at the scheduled time and those who broke perioperative protocol, e.g. the non-intake of the immune supplement in the Acerto group.

Design of the study. Patients were consecutively included and randomized into two groups: Group Control and ACERTO group with the aid of electronic software of random numbers available at www.graphpad.com. All patients were assessed by a multidisciplinary team, who carried out a nutrition assessment, preoperative education, and collected the relevant anthropometric, biochemical and clinical data.

Anesthesia and operative technique. Antibiotic prophylaxis was done with 2g of intravenous kefazolin at the time of anesthetic induction. Measures were taken against postoperative nausea and vomiting (PONV) according to the protocol applied by the anesthesia team and will be discussed in this paper. Preoperative sedation was done with intravenous midazolam (0.03 to 0.1mg/kg) and propofol (30 to 60 mcg/kg/min) No general anesthetic was applied in both groups. All subjects received epidural neuro-axis blockage at L3-L4 space with ropivacain 7.5% to 10% (150-200mg) and morphine chlorate 2mg (30 to 50 micrograms/kg). The surgical access of the hip was done by anterior-lateral approach. The investigators used in all cases hybrid type total arthroplasty (cementation of the femoral component and fixation of the acetabular component by means of pressure fitting of the implant to the bone and the addition of screws to the acetabular cup when necessary).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • We included adult patients (18-80 y/o) of both sex having a hip osteoarthrosis and candidates of elective THA.

排除标准

  • Patients were excluded if they had fasting glycemia greater than 200mg/dl
  • Acquired immunodeficiency (AIDS)
  • Renal failure (creatinin above 2 mg/dl)
  • Cirrhosis
  • Moderate or serious Alzheimer's disease (clinical dementia rating score between 2 and 3)
  • An American Society of Anesthesiologists (ASA) score higher than 2
  • Previous spinal surgery (arthrodesis) or THA (reviewing or changing the prosthetic)
  • Severe malnutrition (history of loss of 10% of body weight over the last 6 months).

结局指标

主要结局

Length of postoperative stay

时间窗: up to 30 days of the postoperative course

days of postoperative stay until discharge up to 30 days

次要结局

  • Serum C-reactive protein(preoperative and 2nd PO day)

研究者

发起方
Federal University of Mato Grosso
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose Eduardo de Aguilar-Nascimento

Chair Professor, MD, PhD

Federal University of Mato Grosso

研究点 (2)

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