Comparison of the Effects of Perioperative Liberal and Restrictive Fluid Management on the Endothelial Glycocalyx Layer in Radical Cystectomy and Urinary Diversion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Hyaluronan (ng/L)
研究概览
简要总结
The aim of this study is to compare the effect of the liberal and restrictive fluid treatments which are routinely performed in major urological surgeries in the perioperative period on ANP release and the endothelial glycocalyx layer.
In the study, the investigators aimed to compare changes in the glycocalyx structure by measuring the blood levels of ANP and heparan sulfate, hyaluronan and syndecan 1, which form the glycocalyx structure on the patients who received the liberal and restrictive fluid treatments during major urological surgeries.
详细描述
There is no strong evidence about the optimal fluid resuscitation for the patients undergoing major surgeries. Avoiding excess fluid resuscitation in the perioperative period is essential for reducing postoperative complications, morbidity and long-term mortality. In the perioperative period, ANP is released with increased wall stress in the cardiac atrium due to excess fluid loading. With the release of ANP, damage occurs in the glycocalyx layer, which is the structure primarily responsible for the permeability in the vascular endothelium.
Thus, the amount of ANP released from atrium and heparan sulfate, syndecan 1, hyaluronan in the glycocalyx layer structure increases in the blood.
The aim of this study is to compare changes in the glycocalyx structure by measuring the blood levels of ANP and heparan sulfate, hyaluronan and syndecan 1, which form the glycocalyx structure on the patients who received the liberal and restrictive fluid treatments during major urological surgeries. The blood samples will be taken at the beginning and at the end of the surgery.
The primary outcome of this study is the increase in ANP levels and heparan sulfate , hyaluronic acid, syndecan 1 levels which are the glycocalyx damage products in blood.
Secondary outcomes are intraoperative advanced hemodynamic cardiac measurement values, the amount of blood and blood products replaced to patients, duration of intensive care stay, duration of hospital stay, cardiac and respiratory complications, gastrointestinal complications, urinary complications, surgical complications such as anastomotic leaks, wound infection and fistula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •ASA (The American Society of Anesthesiologists) status I-II-III patients
- •Cases undergoing major urological surgery
- •Cases for invasive artery monitoring and central venous catheterization
- •Patients receiving general anesthesia
- •Volunteering to participate in the study
排除标准
- •Coagulopathy
- •Patients with severe heart, kidney and liver dysfunction (EF <35% and / or GFR <30, Cre:> 2.5 and / or impaired liver function tests)
研究组 & 干预措施
liberal fluid therapy
Patients will be applied 2 mg midazolam for premedication. Before anesthesia induction, epidural catheter will be inserted to all patients and test dose will be made with 3 cc % 2 lidocaine (No medication from the epidural catheter will be administered during surgery).
Standard anesthesia induction will be applied (fentanyl 2 mcg/kg; propofol 2 mg/kg; rocuronium 0.6 mg/kg ), and after intubation maintenance of anesthesia will be achieved with sevoflurane with a minimum alveolar concentration (MAC) of 0.8-1.
Fluid resuscitation will be started with 10 ml / kg / hr Ringer's lactate solution.
In patients with MAP <65 mmHg, 250 ml of Ringer's lactate solution will be given as a bolus.
If the hypotension persists, the bolus 250 ml Ringer's lactate solution will be repeated up to 10 times.
干预措施: liberal fluid management (Other)
restrictive fluid therapy
Patients will be applied 2 mg midazolam for premedication. Before anesthesia induction, epidural catheter will be inserted to all patients and test dose will be made with 3 cc % 2 lidocaine ( No medication from the epidural catheter will be administered during surgery. ) Standard anesthesia induction will be applied ( fentanyl 2 mcg/kg; propofol 2 mg/kg; rocuronium 0.6 mg/kg ) and after intubation maintenance of anesthesia will be achieved with sevoflurane with a minimum alveolar concentration (MAC) of 0.8-1.
Fluid resuscitation will be started with 2 ml / kg / hr Ringer's lactate solution and norepinephrine infusion at a dose of 2 mcg / kg / hr.
In patients with MAP<65 mmHg, norepinephrine dose will be increased up to 8 mcg / kg / hr.
If the hypotension persists although the norepinephrine dose is 8 mcg / kg / hr, 250 ml bolus Ringer's lactate solution will be given.
干预措施: restrictive fluid management (Other)
结局指标
主要结局
Hyaluronan (ng/L)
时间窗: The blood sample will be taken at beginning and end of the surgery
Blood Hyaluronan concentration will be determined using an enzyme-linked immunosorbent
Atrial Natriuretic Peptide (ANP)( pg/mL)
时间窗: The blood sample will be taken at beginning and end of the surgery
Blood ANP concentration will be determined using an enzyme-linked immunosorbent assay kit
Syndecan 1 (pg/mL)
时间窗: The blood sample will be taken at beginning and end of the surgery
Blood Syndecan 1 concentration will be determined using an enzyme-linked immunosorbent
Heparan sulfate (ng/L)
时间窗: The blood sample will be taken at beginning and end of the surgery
Blood Heparan sulfate concentration will determine using an enzyme-linked immunosorbent assay kit
次要结局
- Thromboembolic complications(30 days postoperative)
- Cardiac complications(30 days postoperative)
- Total intensive care unit (ICU) stay (Hour, day)(30 days postoperative)
- Gastrointestinal complications(30 days postoperative)
- Amount of blood transfusion (unit)(From the beginning surgery to day 2 postoperatively)
- Hospital stay (Hour, day)(90 days postoperative)
- Surgical site complications(30 days postoperative)
- Infectious complications(30 days postoperative)
- Genitourinary complications(30 days postoperative)
- Stroke Volume Variation (SVV)(%)(From onset of the surgery up to end of the surgery, every 30 minutes)
- Systemic Vascular Resistance Index (SVRI )(dyn*s.cm-5 )(From onset of the surgery up to end of the surgery, every 30 minutes)
- Cardiac Index(CI )(l min-1 m-2),(From onset of the surgery up to end of the surgery, every 30 minutes)
研究者
Meltem Savran Karadeniz
Associate Professor
Istanbul University