Effect of Crystalloids With Different SID on Hemodilution, Plasmatic Acid Base Equilibrium and Urinary Electrolytes in Patients During General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- pH modification
研究概览
简要总结
The present study will investigate variations in acid base equilibrium caused by the administration of four different crystalloids with increasing strong ion difference (0.9% saline, Ringer's lactate, Ringer's acetate, plasmalyte-like solution) in patients during general anesthesia.
The same crystalloid will be administered throughout the surgery. In order to assess the effect of hemodilution, every patient will receive two fluid boli with different volumes of the same solution. pH and strong ion variations, togher with the renal response to acid base disturbances, will be analysed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (between 18 and 75 years old);
- •ASA (American Society of Anesthesiologists) physical status classification system 1 or 2;
- •Patients undergoing spinal surgery under general anesthesia, intubated and mechanically ventilated;
- •Normal preoperative albumin;
- •Surgery with an estimated duration of at least 3 hours.
排除标准
- •Patients who are pregnant;
- •Patients with obesity (BMI > 35);
- •Patients with a chronic obstructive pulmonary disease (COPD);
- •Patients with obstructive sleep apnea (OSA) treated with CPAP;
- •Patients with chronic heart failure (CHF) with a NYHA (New York Heart Association) class ≥2;
- •Patients receiving diuretics in the pre-operative period;
- •Patients with a chronic kidney disease (CKD), defined as a GFR < 60 ml/min/1.73 m2;
- •Patients with diabetes mellitus treated with insulin;
- •Patients with myopathies; Patients undergoing a surgery with likely fluid losses or with unexpected bleeding during surgery.
研究组 & 干预措施
Chloride-rich solution
Patients will receive two boluses of 10 and 20 ml/kg of the 0.9% saline in two different moments after at least 1 hour from each other. Plasma arterial blood gas (ABG) and electrolytes, along with plasmatic creatinine, albumin and phosphate will be measured immediately before and five minutes after fluid boluses. Urinary electrolytes (Na, K, Cl) will be measured immediately before fluid bolus and after one hour from fluid administration along with ABG and plasmatic electrolytes and creatinine, phosphate and albumin.
干预措施: 0.9% saline administration (Other)
Low-chloride solution A
Patients will receive two boluses of 10 and 20 ml/kg of Ringer's lactate in two different moments after at least 1 hour from each other. Plasma arterial blood gas (ABG) and electrolytes, along with plasmatic creatinine, albumin and phosphate will be measured immediately before and five minutes after fluid boluses. Urinary electrolytes (Na, K, Cl) will be measured immediately before fluid bolus and after one hour from fluid administration along with ABG and plasmatic electrolytes and creatinine, phosphate and albumin.
干预措施: Ringer's lactate administration (Other)
Very low-chloride solution
Patients will receive two boluses of 10 and 20 ml/kg of a plasmalyte-like solution (namely soluzione elettrolitica reintegrante [SER]) in two different moments after at least 1 hour from each other. Plasma arterial blood gas (ABG) and electrolytes, along with plasmatic creatinine, albumin and phosphate will be measured immediately before and five minutes after fluid boluses. Urinary electrolytes (Na, K, Cl) will be measured immediately before fluid bolus and after one hour from fluid administration along with ABG and plasmatic electrolytes and creatinine, phosphate and albumin.
干预措施: Plasmalyte-like solution administration (Other)
结局指标
主要结局
pH modification
时间窗: Surgery
The primary outcome of this physiological study is to evaluate, in vivo, the effect of crystalloid administration with different SID on acid base equilibrium, in particular pH variations will be considered.
次要结局
- SID and plasmatic weak acid (A tot) variations measured in mEq/L(Surgery)
- Urinary SID modification (mEq/L) after crystalloids administration with different SID and chloride load(Surgery)
研究者
Antonio Maria Dell'Anna
Medical Doctor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS