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临床试验/CTRI/2023/07/055007
CTRI/2023/07/055007招募中4 期

Intraoperative Liberal versus Goal-directed Fluid Therapy in Neonates undergoing Laparotomy- A Prospective Randomized Controlled Trial

Department of Anesthesia and Intensive Care1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年7月16日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
To compare the total amount of fluid infused intraoperatively in ml/ kg in both the groups

研究概览

简要总结

Intraoperative fluid therapy is an important aspect of perioperative care in neonates undergoing laparotomy, as maintaining adequate fluid balance is crucial for optimal outcomes.

-Liberal fluid therapy involves administering fluids more generously, often based on subjective clinical assessment and individual physician preferences. The aim is to ensure that the neonate has adequate circulating volume to maintain blood pressure and organ perfusion during surgery. This approach may involve administering fluids at a higher rate and/or larger volumes without strict adherence to specific hemodynamic targets. Advantages of liberal fluid therapy may include simplicity in application and rapid correction of hypovolemia if present. However, there are concerns associated with this approach. Excessive fluid administration can lead to fluid overload, which may result in edema, impaired organ function, and increased morbidity. Fluid overload can be particularly problematic in neonates, who have limited cardiovascular reserves.

-Goal-directed fluid therapy (GDFT) involves a more individualized and targeted approach to fluid administration. It aims to optimize hemodynamic parameters and tissue perfusion based on objective measures. GDFT involves continuous monitoring of specific parameters, such as central venous pressure (CVP), mean arterial pressure (MAP), cardiac output (CO), or stroke volume (SV), and plethysmograph variability index (PVI) to guide fluid administration. The goals typically focus on maintaining adequate cardiac output and oxygen delivery while avoiding fluid overload. Hemodynamic monitoring techniques such as arterial and central venous catheters, transesophageal Doppler, or non-invasive devices like PVI may be used to guide fluid therapy decisions. GDFT has been shown to be beneficial in various surgical settings, as it helps avoid both under- and over-resuscitation, optimizing fluid management and reducing complications.

The Pleth Variability Index (PVI), is a dynamic and non-invasive parameter, which can be utilized to administer GDFT. This study aims to compare the volume of fluids infused using PVI-based GDFT with the conventional method of fluid administration in neonates undergoing emergency laparotomy. The postoperative metabolic and hematological profile and clinical outcomes like bowel movement, anastomotic leak and the duration of hospital stay will also be compared.

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
0.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • 1.Term and Late preterm neonates, (GA> 35 weeks) up to 28 days of life.
  • 2.Emergency procedures.
  • 3.Anticipated duration of surgery > 60minutes.

排除标准

  • 1.Children with associated medical conditions like Cardiac anomaly, Pulmonary anomaly/severe respiratory disease, Hepatic disease 2.Weight <2 kgs 3.Abdominal surgery where visceral exposure is not anticipated.
  • •Anticipated massive blood transfusion.
  • •Hb < 10 gm/dl •Evidence of hypovolemia before induction of anaesthesia.
  • •Preoperative inotropes.

结局指标

主要结局

To compare the total amount of fluid infused intraoperatively in ml/ kg in both the groups

时间窗: END OF SURGERY

次要结局

  • Recovery of bowel function(Postoperative period till confirmation of bowel sounds)
  • Duration of hospital stay(Postoperative period till the discharge of the patient)
  • Intraoperative lactate & base excess levels(Baseline & at the end of surgery before shifting the patient out of the Operating Room)
  • Serum electrolytes(Baseline & at the end of surgery before shifting the patient out of the Operating Room)

研究者

发起方
Department of Anesthesia and Intensive Care
申办方类型
Research institution and hospital

研究点 (1)

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