Perioperative Fluid Treatment in Colorectal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 主要终点
- Postoperative complications and mortality
研究概览
简要总结
This is a protocol for a trial carried out from 1999 to 2002. At that time, surgical patients received a large volume of intravenous saline during operations on the colon or the rectum, often so much fluid that their bodyweight increased by 4-6 kilograms. We hypothesized; that a restricted fluid regimen could prevent the development of cardiopulmonary complications and improve wound healing including the healing of an anastomosis of the gut.
We designed a clinical randomized assessor blinded multi-center trial comparing a restricted fluid regimen to a standard fluid regimen, the difference being the volume of saline administered to the patients. Patients undergoing surgery on the colon or the rectum were included after informed oral and written consent.
The restricted regimen aimed at zero-fluid balance with allowance for a body weight increase of 1 kg. The standard regimen was a bit "dryer" than the actual standard; our patients in the standard group received saline causing a body weight increase of only 3-4 kg. The fluid therapy started at midnight the day of operation, went on through the operation and continued on the wards until discharge. The patients were encouraged to eat and drink as much and as soon as possible after the operation.
The primary outcome was the number of patients who died or suffered a complication measured within 30 days of surgery. We looked at all complications, but especially heart and lung complications and complications related to the healing of wounds and anastomosis.
The patients was examined in the outpatient clinic after 30 days, and in addition, blinded assessors were reviewing the medical files for registration of postoperative complications.
The results are published in The Annals of Surgery 2003; 238(5)641-48. The restricted regimen nearly halved the number of patients with complications, and heart and lung complications were almost eliminated.
Other investigators confirmed the results, and a more restricted approach to fluid therapy to surgical patients has been implemented worldwide.
详细描述
Aim:
To show the effect of a restrictive fluid regime compared to a standard regime by the frequency of complications in patients undergoing colorectal surgery.
Background:
Previous studies have risen suspicions of fluid balance, and especially a large amount of water and NaCl administration, can be a significant factor in developing postoperative complications (1, 2).
In 1990 in Critical Care Magazine, Lowell et al. described patients who in transferring to intensive therapy had an increased weight of > 10% of their preoperative weight, had a significantly higher mortality rate of 31.6 % than patients with an increased weight of < 10%, who only had a mortality rate of 10.3 %.
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
- Single (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
- •Patients scheduled for planned surgery on the colon or the rectum
- •ASA group 1-3
排除标准
- •Patients unable to give informed consent (mental disorders, dementia, language problems)
- •Patients with:
- •Diabetes mellitus
- •Renal insufficiency
- •Disseminated cancers or secondary cancers
- •Inflammatory bowel disease
- •Diseases hindering epidural analgesia
- •Alcohol consumption more than 35 drinks pr. Week
- •Pregnant and lactating woman.
研究组 & 干预措施
Standard group
Oral fluid to 2 h before surgery. Intra-operatively: Saline 500 ml for fasting; 500 ml HAES 6% for the epidural, Saline for the third space: 7 ml/kg/h first hour, 5 ml/kg/h 2.-3. Hour, 3 ml/kg/h subsequent hours. 1000-1500 ml Saline replaced lost blood up to 500 ml, additional HAES 6% for additional blood loss; IV-medicine in saline.
Postoperatively: 1000-2000 ml isotonic fluid in the recovery room. Free oral fluid and food as well as enteral feeding by tube 500 ml.
In the wards: Enteral feeding by tube 1000 ml postoperative day 1-3. Free fluid and food by mouth. Supplemental iv-fluid according to department rules. Pathological fluid loss (high output stoma, aspirate, vomit etc.) - replace with IV-fluid.
Urine < 0.5 ml/kg/h: supplement with fluid. MAP < 60 and hypovolemia: treat with fluid.
干预措施: Saline (Drug)
Restricted group
Oral fluid to 2 h before surgery. Intra-operatively: Glucose 5% (500 ml - volume drunk during fast); HAES 6% for blood loss volume to volume; IV-medicine in saline 0.9% for anesthesia and antibiotics. Blood products after current rules.
Postoperatively: 1000 ml glucose containing fluid in the recovery room. Free oral intake of fluid and food as well as enteral feeding by tube 500 ml.
In the wards: Enteral feeding by tube 1000 ml postoperative day 1-3. Free fluid and food by mouth. If less than 1500 ml fluid pr. mouth supplement with VI-fluid.
Pathological fluid loss (high output stoma, aspirate, vomit etc.) - replace with IV-fluid. Goal: zero fluid balance with up to 1-kilogram body weight increase.
Urine < 0.5 ml/kg/h: supplement with fluid. MAP < 60 and hypovolemia: treat with fluid.
干预措施: Saline (Drug)
结局指标
主要结局
Postoperative complications and mortality
时间窗: After 30 days of follow-up
The complications was defined by protocol.
次要结局
- Cardiopulmonary complications(After 30 days of follow-up)
- Complications related to tissue healing(After 30 days of follow-up)
研究者
Birgitte Brandstrup
Chief Surgeon, Clinical Associate Professor, PhD
Holbaek Sygehus