A Comparison of Balanced Salt Solution vs. Normal Saline in Major Abdominal Surgery: A Quantitative Acid Base Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Difference in chloride concentration of less than 3 mEq/L between the plasmalyte and normal saline groups at the end of surgery with restrictive fluid regimen.
研究概览
简要总结
The acidosis attributed to Normal Saline has a clear dose-dependent effect with larger volumes associated with this phenomenon. However, the exact quantitative impact of this solution when used in a restrictive paradigm is not adequately assessed in the current literature. Thus, this study attempted to assess the effects of Plasmalyte vs. Normal saline when used in restrictive quantities as determined by a pre-defined hemodynamic algorithm which used dynamic indices like SPV and PPV. Such an assessment was made on the freely available physicochemical acid-base calculator designed by John Kellum and provided as an editable excel sheet. It was hypothesized that the quantitative differences between the two infusion fluids under study would likely not be significant to alter clinical outcomes.
The aim was to determine the equivalence or otherwise of Normal Saline in comparison to Plasmalyte for intra-operative fluid replacement in elective, adult open abdominal surgery on serum chloride level using a restrictive fluid therapy algorithm.
Previous studies had reported a difference of approximately 6 mEq/l in the chloride levels when saline was used in comparison to Plasmalyte at the volumes infused in the study. We hypothesized that the difference would be much smaller (<3 mEq/L) when smaller volumes ( 2ml/kg/hr + urine output + blood loss every hour ) of fluid were infused using a dynamic index to titrate fluid therapy and that both fluids would be demonstrated to be equivalent.
SUMMARY and RESULTS:1) Restrictive fluid regimen shows equivalence in the choice of crystalloid fluid ( Plasmalyte versus Normal saline) used for intraoperative fluid therapy.
- Infusing fluids according to the algorithm lead to a decrease in pH but not significant acidosis (pH< 7.35) in both the groups even at postoperative day one.
3)The constituents of crystalloids have an impact on the acid-base balance as seen with changes in independent parameters of Stewart. These changes may become significant if fluids are given in larger volume for a longer duration.
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Normal saline has an obvious impact on urine output even when given in restricted amounts but these did not amount to renal injury.
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In surgeries of prolonged duration with a restrictive regimen, a close watch on lactate to prevent tissue hypoperfusion is necessary which shows a trend of increase with duration of surgery in our study.
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Dynamic indices like PPV are effective in guiding fluid therapy intraoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult ASA physical status I-III patients presenting for elective open abdominal surgery under GA at PGIMER, Chandigarh.
排除标准
- •Patients with pre-existing renal dysfunction (Sr. creatinine > 1.5mg/dl), those with abnormal sodium, potassium, chloride levels on pre-operative biochemistry screen, resting elevations of PaCO2, known clinical lung disease, H/O congestive heart failure or pulmonary hypertension, pre-operative use of diuretic or steroid replacement therapy, Hb<7gm/dl and those refusing consent were excluded from study participation.
结局指标
主要结局
Difference in chloride concentration of less than 3 mEq/L between the plasmalyte and normal saline groups at the end of surgery with restrictive fluid regimen.
时间窗: Difference in chloride concentration of less then 3 mEq/L
次要结局
- Acidosis at first post operative day .(pH less than 7.35)
- decreased urine output with restrictive regimen leading to risk of renal injury(urine output less than 0.5ml/kg/hr .)