Which Goal for Fluid Therapy During Colorectal Surgery is Followed by the Best Outcome: Near Maximal Stroke Volume or Restricted Fluid Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 主要终点
- Number of participants with a postoperative complication
研究概览
简要总结
This is a clinical randomised double blinded multicentre trial of two different fluid treatments during colorectal surgery in an enhanced recovery programme A restricted fluid regimen aiming at zero fluid balance and less than two kilograms bodyweight change was compared with another fluid regimen where intravenous fluids were given to reach near maximal stroke volume of the heart, guided by a Doppler in the oesophagus.
The primary outcome was a composite outcome of postoperative complications and death.
Included was 150 patients undergoing elective colorectal surgery. No difference was found between the two groups. Both fluid therapies resulted in low complication rates. The difference in fluid volume between the groups was only 600 ml on the day of operation.
The results are published, see reference section.
详细描述
Background Hypovolemia can cause postoperative complications, circulatory collapse and death, regardless if the cause is blood loss or loss of other fluids. Therefore, doctors are giving fluid intravenously to patients undergoing surgery, and often in an amount larger than the measured losses. Recent studies, however, have shown that also fluid overload plays a part in complication development after surgery (1-3). It is therefore important to find the optimal fluid treatment for surgical patients.
In Denmark, approximately 3500 patients are undergoing surgery every year for colorectal cancer, and in addition, operations are performed for benign diseases. However, the complication rate after colorectal surgery remains high (approximately 30%).
Disagreement about which fluid treatment is optimal exist between three "schools for fluid therapy":
- "Standard fluid therapy" which in addition to replacing external fluid loss (blood loss, urine and evaporation) include fluid to replace a "third space loss" and fluid to counteract low blood pressure (4-5). Standard therapy is poorly defined and differ between hospitals. It cause a bodyweight increase by 3-6 kilo (6-7).
- "Goal-directed fluid therapy", where volume is given in a bolus injection of a colloid (typically hydroxyethyl starch (HES)) in order to keep the patient's stroke volume (SV) at a near maximum level (1). The heart is brought close to maximum performance. In theory, hypovolemia is prevented and oxygen supply to the tissues increased. In the studies available, HES is given on top of "standard therapy" and "Goal-directed fluid therapy" therefore result in a weight gain not measured in the available studies.
- "Restrictive fluid therapy", replace only measurable fluid losses and strive to maintain the patient's normal (preoperative) body weight. The hypothesis is that excess fluid cause interstitial edema which may be harmful to the healing of tissue and function. (2,3,8).
"Standard fluid therapy" is meaningful if a benefit exists in giving fluid to a possible third space loss and treat the vasodilatation caused by epidural analgesia by volume. However, a recent critical review of the literature poses serious doubts about the existence of a third space loss (9), and no beneficial effect of volume treatment of the vasodilatation caused by epidural analgesia been shown.
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
- Double (Participant, 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
- •All patients scheduled for colorectal resections if it is preoperatively estimated that the surgery may be cancer radical.
- •ASA level 1-4.
排除标准
- •Emergency surgery,
- •Alcohol consumption > 5 units daily,
- •Inability to give informed consent (language problems, unconscious, psychosis (including confusion))
- •Pregnant and lactating women
- •Contraindication for the use of HES (severe renal impairment, allergy, severe bleeding disorders and pregnancy)
- •Other non-radically treated malignant diseases
研究组 & 干预措施
Stroke volume (SV) group
As bellow but with the addition of HES (Voluven (R)) to near maximal stroke volume of the heart:
A bolus injection of 200 ml Voluven® is given repeatedly with measurement of the SV until the increase in SV in response to the bolus is <10%.
The Case Report File give detailed instructions for the interpretation of the SV during changes in position of the patient during laparoscopic surgery.
干预措施: Voluven to near maximal stroke volume of the heart (Drug)
Restricted group
Preoperatively: Clear oral fluids until 2 h before surgery. During surgery: If preoperative fluid intake <500 ml, NaCl 0.9% is given until 500 ml.
Lost blood is replaced volume by volume with HES (Voluven®) with allowance of 500 ml extra.
Postoperative fluid: The rest of the day of surgery, fluid is given to meet the basic needs, i.e. 1000 ml K-Na-glucose, K-glucose or glucose 5%. The patient is encouraged to drink and eat as soon possible.
In the surgical department, fluid charts and weight changes monitor fluid balance. A body weight increase of two kilograms is allowed.
Fluid losses is replaced with a fluid having a similar electrolyte composition as the loss and in an equal volume. If the weight increases more than two kilogram, furosemide is given to increase the diuresis.
干预措施: Voluven to near maximal stroke volume of the heart (Drug)
结局指标
主要结局
Number of participants with a postoperative complication
时间窗: 30 day follow-up
Only complications demanding surgical or medical treatment. Diagnostic criteria for each complication was given by protocol
次要结局
未报告次要终点
研究者
Birgitte Brandstrup
Sponsor
Holbaek Sygehus