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临床试验/NCT06089551
NCT06089551招募中4 期

Early Versus Postponed Supplementary Parenteral Nutrition After Major Emergency Abdominal Surgery: a Randomized, Controlled Multicenter Trial

Copenhagen University Hospital at Herlev1 个研究点 分布在 1 个国家目标入组 342 人开始时间: 2023年10月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
342
试验地点
1
主要终点
Infectious complications during admission

研究概览

简要总结

The aim of this study is to investigate the effect of early, supplementary parenteral nutrition following emergency laparotomy.

Currently, parenteral nutrition is used in postoperative patients if or when oral or enteral nutrition is not feasible. However, little data exists on the optimal timing of parenteral nutrition.

Oral and enteral nutrition is encouraged. Participants will randomized on the second postoperative day if their calorie intake (oral + enteral) is below 50% of the calculated requirement. Patients will be randomized to early (postoperative day 2) or postponed (postoperative day 5) start of parenteral nutrition.

The combined oral + enteral + parenteral calorie target is 70-80% of the calculated requirement. Participants in the postponed group will be re-assessed on postoperative day 5, and if their calorie intake is less than 50% parenteral nutrition will be administered.

The intervention will continue until oral + enteral intake is at least 70% of the calculated requirement or the participant is at his/her habitual intake.

详细描述

Screening for potential participants will be done using the patient records which includes primary procedure, age, NRS-2002 score, and total calorie intake within the last 24 hours. Only information needed to determine eligibility in this study will be noted ahead of informed consent.

Enteral or oral feeding is encouraged as soon as possible postoperatively for all patients unless they have contraindications for oral intake. If they have contraindications for oral intake they are excluded from participation (Appendix 2). The caloric target is set to 25 kcal/kg/day. For patients with a body mass index > 30 kg/m2 the target will be calculated using their weight at body mass index 25 kg/m2. Oral protein supplements are encouraged in all patients. Nutritional calculations and monitoring can be performed locally according to the participating centers' standard clinical practice by dieticians, nurses, or clinical doctors.

Patients that cannot achieve more than 50% of their calorie intake on POD2 and do not fulfill any of the exclusion criteria are randomized to early parenteral (E-SPN) (POD2) or postponed parenteral (L-SPN) (POD5). The L-SPN group will continue standard oral or enteral intake until POD5 where the parenteral nutritional intervention begins if they have not yet met at least 50% of recommended daily oral or enteral recommended intake on their own.

After randomization, the patients should receive 70-80% of recommended daily energy and protein intake. Calculations will be made daily by a combination of oral, enteral, and parenteral administered nutrition. In case of incomplete calorie intake registration, the most recent dose will be administered.

If patients are in need of supplemental parenteral nutrition for more than seven days, a centrally administered route should be used. The standard trial supplemental nutritional product will be SmofKabiven® Perifer unless there is a clinical rationale for using SmofKabiven. These include treatment duration > 7 days, risk of overhydration, calorie requirement exceeding the limit for SmofKabiven Perifer (1300 kcal). Both products will be used in accordance with the summary of product characteristics. Use of either product is not expected to impact data analysis as supplementary calorie amount is unrelated to the product.

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
None

入排标准

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

入选标准

  • Age > 18
  • Emergency primary midline laparotomy or laparoscopy
  • NRS-2002 (nutritional risk screening) score < 7
  • No contraindications for oral or enteral nutrition after surgery
  • Unable to tolerate or take in at least 50% of calculated calorie requirement on postoperative day 2
  • Capable of providing informed consent at the time of inclusion

排除标准

  • Laparotomy without closure of the abdominal aponeurosis
  • Laparoscopic appendectomy or cholecystectomy as the procedure
  • Limiting mental or psychiatric disorders rendering participation unethical or unrealistic
  • Patients with a very limited expected remaining time of living (< 3 months)
  • NRS-2002 = 7
  • Pregnant or breastfeeding women
  • Refusal to participate

研究组 & 干预措施

Early supplementary

Experimental

Start of study drug on postoperative day 2

干预措施: SmofKabiven (Drug)

Late supplementary

Active Comparator

Start of study drug on postoperative day 5

干预措施: SmofKabiven (Drug)

结局指标

主要结局

Infectious complications during admission

时间窗: 1 week after hospital discharge

Rate of infectious complications during admission. The following infections will be registered: Urinary tract infections, pneumonia, bloodstream infections, surgical site infections, abdominal infections, and skin and soft tissue infections,

次要结局

  • Non-infectious complication rate during admission(1 week after hospital discharge)
  • Emergency readmission rate (day 30 and 90)(Assessed 90 days after surgery)
  • Days with need for antibiotics(1 week after hospital discharge)
  • Post-discharge weight status(Assessed at day 30 and 90 after surgery)
  • Length of stay(Up to 30 days)
  • Mortality rate (day 30 and 90)(Assessed 90 days after surgery)
  • Energy intake during admission(Up to two weeks)
  • Post-discharge nutritional status(Assessed at day 30 and 90 after surgery)
  • Protein intake during admission(Up to two weeks)
  • Routes of energy delivery(Up to two weeks)

研究者

发起方
Copenhagen University Hospital at Herlev
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jannick Brander Hansen

Principal Investigator

Copenhagen University Hospital at Herlev

研究点 (1)

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