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临床试验/NCT03080831
NCT03080831已完成4 期

TOnicity of Perioperative Maintenance SoluTions - Part 1: Thoracic Surgery

Niels Van Regenmortel1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年3月9日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Fluid balance
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Prospective randomized double blind phase IV trial studying the efficacy and safety of the tonicity of two different perioperative maintenance solutions: an isotonic solution containing NaCl 0.9 in glucose 5% with an added 40 mmol/L of potassium or a commercially available premixed solution (Glucion 5%) containing a.o. 54 mmol/L of sodium and 26 mmol/L of potassium. Both solutions are administered at 27 mL/kg of ideal body weight, as recommended by current guidelines (NICE 174) and both solutions are widely used in daily clinical practice. The primary hypothesis is that isotonic maintenance solutions lead to more fluid retention than hypotonic fluids. Metabolism of both solutions is assessed by sequential analysis of urine and serum and clinical parameters.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Study fluids blinded using opaque bags

入排标准

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

入选标准

  • •Adult (at least 18 y.o.)
  • •Undergoing elective lung resection (wedge resection, segmental resection, (bi)lobectomy, but not pneumonectomy) via thoracotomy or video- or robot assisted (VATS, RATS)
  • •Normal renal function (eGFR >60 ml/min/1.73m² (CKD-EPI))

排除标准

  • •Under chronic treatment with diuretics or desmopressin
  • •Heart failure (NYHA III-IV)
  • •Liver Failure
  • •Brittle diabetes mellitus
  • •Neurological contra-indication for hypotonic fluids
  • •SIADH or hyponatremia <130 or > 150 mmol/L at preoperative assessment
  • •Hyperkalemia > 5 mmol/L at preoperative assessment
  • •Under treatment with artificial nutrition (enteral or parenteral)
  • •Pregnancy
  • •Additional pre-defined exclusion after initial inclusion
  • •Massive perioperative transfusion or intraoperative resuscitation of +2.5L of crystalloids/colloids
  • •Absence of admission to ICU

研究组 & 干预措施

NaCl 0.9% in Glucose 5% + 40mmol/L Potassium

Active Comparator

干预措施: NaCl 0.9% in Glucose 5% + 40mmol/L Potassium (Drug)

Glucion 5%

Active Comparator

干预措施: Glucion 5% (Drug)

结局指标

主要结局

Fluid balance

时间窗: From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery)

Difference between all fluid intake and output

次要结局

  • Electrolyte Homeostasis and Disorders: Sodium(From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery) - Assessments at fixed time points.)
  • Electrolyte Homeostasis and Disorders: Potassium(From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery) - Assessments at fixed time points.)
  • Clinical Endpoints: occurrence of de novo atrial fibrillation(From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery). Continuous assessment.)
  • Resuscitation Fluids(From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery))
  • Vasopressor Use(From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery))
  • Physiological Mechanisms: Aldosterone level(From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery) - Assessments at fixed time points.)
  • Physiological Mechanisms: Fractional Excretion of Sodium(From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery) - Assessments at fixed time points.)
  • Electrolyte Homeostasis and Disorders: Chloride(From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery) - Assessments at fixed time points.)
  • Electrolyte Homeostasis and Disorders: Strong Ion Difference(From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery) - Assessments at fixed time points.)
  • Clinical Endpoints: paO2/FiO2(From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery) - Assessments at fixed time points.)
  • Electrolyte Homeostasis and Disorders: Phosphate(From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery) - Assessments at fixed time points.)
  • Electrolyte Homeostasis and Disorders: Calcium(From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery) - Assessments at fixed time points.)
  • Clinical Endpoints: occurrence of acute kidney injury (AKI)(From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery). Continuous assessment.)
  • Sodium balance(From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery).)

研究者

发起方
Niels Van Regenmortel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Niels Van Regenmortel

Dr.

University Hospital, Antwerp

研究点 (1)

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