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临床试验/NCT03905408
NCT03905408已完成1 期

PLeurodesis Using Hypertonic Glucose Administration to Treat Post-operative Air Leaks Following Lung Resection Surgery (PLUG-I): Phase 1

Lawson Health Research Institute1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年9月17日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
12
试验地点
1
主要终点
Occurrence of treatment related adverse events

研究概览

简要总结

The investigators will define the most appropriate safe dose of D50 to heal air leaks in patients that have undergone lung resection surgery

详细描述

The investigators will define the most appropriate safe dose of D50 to heal air leaks in patients that have undergone lung resection surgery (Phase I study). Air leaks from unhealed lung tissue are one of the most common complications after lung surgery including wedge resection, segmentectomy and lobectomy. Air leaks can lead to a delay in chest tube removal, prolonged pain, increased infections, prolonged hospital stay, and increased costs to the health care system. Different agents have been used to heal air leaks by creating a pleurodesis (adhesions to obliterate the pleural space between the visceral and parietal pleura). The success with these agents has been variable and come with the cost of complications that have restricted their use the post-operative period. There has been recent interest in the use of 50% hypertonic glucose (D50) to create pleurodesis with encouraging reports coming mostly from Asia. The investigators have performed a pilot study using 180 mL of D50 instilled through the chest tube for the management of post lobectomy air leak with very encouraging results. This preliminary study used strict inclusion criteria of only lobectomy patients and excluded all patients with known diabetes or any postoperative hyperglycemia. It is unknown if these patients would have benefitted from D50. Also, the optimal dose of D50 was chosen empirically and never clearly defined by previous work. It has been reported that high doses of D50 have been associated with acute lung injury. It is therefore critical that the optimal safe dose is clarified.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
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

  • 18 years old or older
  • Lung resection is a wedge, segmentectomy, lobectomy or bilobectomy
  • Procedure performed by video-assisted thoracic surgery (VATS) or by Thoracotomy
  • Presence of an air leak on the digital draining system on postoperative day 2

排除标准

  • Large air leak arbitrarily defined as more than 1000 mL/min
  • Allergy to local anesthetics
  • Hemodynamic instability
  • Untreated coronary artery disease
  • Need for respiratory support
  • Any other early post-operative complication
  • Immunity disorder
  • Large pleural fluid output empirically defined as more than 500 mL in the last 12 hours
  • Inability to give consent
  • Fasting glucose ≥ 14 mmol/L the morning of the intervention (arbitrarily chosen cut-off in which patients' diabetes is considered very poorly controlled)
  • Endocrinology service not available to co-manage patients with either diabetes, or a fasting blood glucose ≥ 7 mmol/L, or HbA1c > 6.5%
  • Postoperative evidence of an active thoracic (lung or pleura) infection with systemic inflammatory response syndrome (2 or more of temperature > 38, heart rate > 90, respiratory rate > 20, white blood cell count > 12)

研究组 & 干预措施

50 mL Dextrose

Experimental

50 mL of 50% dextrose

干预措施: 50 mL of 50% Glucose (Drug)

100 mL Dextrose

Experimental

100 mL of 50% dextrose

干预措施: 100 mL of 50% Glucose (Drug)

150 mL Dextrose

Experimental

150 mL of 50% dextrose

干预措施: 150 mL of 50% Glucose (Drug)

200 mL Dextrose

Experimental

200 mL of 50% dextrose

干预措施: 200 mL of 50% Glucose (Drug)

结局指标

主要结局

Occurrence of treatment related adverse events

时间窗: 1 year

occurrence of treatment related adverse events (Grade 3 and more as assessed to the CTCAE v4.0) at any given dose of D50

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Malthaner

MD, Chair/Chief Thoracic Surgery

Lawson Health Research Institute

研究点 (1)

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