Perioperative Fluid Management: Goal-Directed Therapy vs. Restrictive Approach, a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- composite index of serious postoperative adverse events
研究概览
简要总结
There is no ideal "cookbook recipe" for fluid prescription that would fit every surgical patient.
In this study, the investigators working hypothesis is that the adoption of an integrative algorithm for perioperative fluid and haemodynamic management would improve clinical outcome and reduce hospital resource utilization in noncardiac surgical procedures (major-to-intermediate level of stress.
Two intraoperative fluid strategies will be compared: "Restrictive" vs. "goal-directed therapy (GDT)". In the GDT group, haemodynamic information will be obtained by a flow monitoring device coupled with standard heart rate and blood pressure monitoring.
详细描述
The rationale of minimizing body weight gain and avoiding unnecessary fluid compensation of the "third compartment" is now well justified and achievement of supra-normal oxygen delivery values is likely not necessary in most surgical patients. Therefore,it would be tempting to adopt fluid restriction protocols given the potentials of better wound healing, faster return of bowel function and shorter hospital stay after major surgical procedures.
Although dynamic flow indices of volume responsiveness have been validated in critically-ill patients, concerns have been raised regarding the risk of overzealous fluid administration in non-critically-ill patients undergoing elective surgery.
To date, RCTs comparing fluid regimen ("liberal" versus "restrictive" or "liberal" versus "GDT") have yielded controversial results with no consensus regarding appropriate fluid administration in the perioperative period. Interestingly, restrictive protocols have been associated with more frequent adverse events (e.g., nausea, vomiting) following minor surgical procedures and concerns have been raised regarding the possibility of tissue hypoperfusion leading to end-organ dysfunction.
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
- Single (Participant)
盲法说明
Patients, clinical care givers and assessors are blinded to the the treatment (GDT or restrictive).
Sealed enveloppes contain the patient' identification number. A person not involved in the study prepare the enveloppes with the identification number.
Investigators who are assessing the postoperative study outcomes are blinded to the treatment arms
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 patient
- •elective noncardiac surgery (moderate-high-risk) lasting > 2h hours (, gastrectomy, pancreatectomy, nephrectomy, radical cystectomy, hepatic resection, open colonic or rectal surgery)
排除标准
- •end-stage organ failure (hemofiltration/dialysis; Child-Pugh class C or MELD score >22; predicted forced expiratory volume < 30%, severe heart failure)
- •life expectancy < 24h
- •psychiatric disorders or unability to give independent consent to the study
研究组 & 干预措施
Restrictive strategy
Crystalloids are given at a fixed rate of 3-6 ml/kg/h. Otherwise, vasopressors can be used to achieve appropriate MAP (>70 mmHg, within ±20% of baseline).
Blood losses are replaced with colloids (1:1) or crystalloids (2:1). Clinicians in charge of the patients are free to use hemodynamic parameters such as PVV or SVV, always attempting to limit the amount of fluid infusion and to maintain normovolemia
干预措施: Restrictive fluid therapy (Procedure)
Goal-Directed-Therapy (GDT)
Besides the basal infusion of crystalloids at 3-6 ml/kg/h, colloids (200 ml) or crystalloids (200 ml) are given over 10 min in the presence of signs of absolute/relative hypovolemia as detected by a fall in cardiac output/stroke volume (CO/SV) or if Pressure Pulse Variation (PVV) or Stroke Volume Variation (SVV) exceeds 10-12%, particularly in the presence. Fluid filling is interrupted when SV fail to increase > 10% (or PVV/SVV =< 10%) Otherwise, vasopressors can be used to achieve appropriate mean arterial pressure (MAP>70 mmHg, within ±20% of baseline).
Blood losses are replaced with colloids (1:1) or crystalloids (2:1).
干预措施: Goal-directed therapy (Procedure)
结局指标
主要结局
composite index of serious postoperative adverse events
时间窗: from date of surgery till hospital discharge or 30-day postoperative
early postoperative major outcomes: mortality, cardiovascular, respiratory, renal and infectious complications
次要结局
- fluid balance(intra-operative and first 24hours after surgery)
- survival(survival 1-3 years after surgery)
- body weight changes (kg, postoperative value - preoperative value)(from date of surgery till hospital discharge, or 30-day postoperative)
- Sequential Organ Failure Assessment (SOFA)(from date of surgery till hospital discharge, up to 15 weeks after date of surgery)
- tissue oximetry (%)(intraoperative period, day of surgery)
- Acute Kidney Injury based on RIFLE(from the day before to 3 days after surgery)
研究者
Marc Licker
Professor, MD
University Hospital, Geneva