Comparison of Isotonic Versus Hypotonic Fluids in Neonates Receiving Maintenance Fluid Therapy Post-Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Incidence of Hyponatremia and Hypernatremia
研究概览
简要总结
The goal of this clinical trial is to determine if isotonic or hypotonic fluids are more effective in maintaining serum sodium levels in neonates undergoing maintenance fluid therapy post-surgery. The main questions it aims to answer are:
Does isotonic fluid therapy reduce the risk of hyponatremia compared to hypotonic fluid therapy? Does hypotonic fluid therapy lead to fewer cases of hypernatremia compared to isotonic fluid therapy? Researchers will compare neonates receiving isotonic fluids (Group I: isotonic/normal saline with 5% dextrose in 0.9% saline) to those receiving hypotonic fluids (Group H: hypotonic saline with 5% dextrose in 0.45% saline) to see if there are significant differences in serum sodium levels and associated complications.
Participants will:
Be randomly assigned to receive either isotonic or hypotonic fluids. Have blood samples taken before and after surgery to assess serum sodium levels.
Be monitored for 24 hours post-surgery to observe any complications such as hyponatremia, hypernatremia, or edema.
This study enrolled 84 neonates admitted to the neonatal intensive care unit following surgery, and data analysis was conducted using SPSS software version 25.0.
详细描述
The primary objective of this clinical trial is to determine the most appropriate type of maintenance fluid (isotonic versus hypotonic) for neonates following surgery. The study enrolled 84 neonates, aged 1-28 days, who were admitted to the neonatal intensive care unit at Holy Family Hospital Rawalpindi from January 2023 to December 2023.
Neonates were randomly assigned into two groups:
Group I: Received isotonic/normal saline with 5% dextrose in 0.9% saline. Group H: Received hypotonic saline with 5% dextrose in 0.45% saline. Blood samples were collected before surgery and 24 hours post-surgery to measure serum sodium levels. The main outcome measures were the incidence of hyponatremia (serum sodium level <135 mEq/L) and hypernatremia (serum sodium level >145 mEq/L). Secondary outcomes included other complications such as edema.
The results indicated that:
Hyponatremia occurred in 2 (4.8%) cases in the isotonic group and 11 (26.2%) cases in the hypotonic group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
In this study, masking is implemented at the participant level. This means that the neonates (participants) and their caregivers are unaware of whether the neonate is receiving isotonic or hypotonic fluids. However, the clinical staff administering the fluids and assessing outcomes are not blinded to the intervention group. This approach helps reduce bias in the perception and reporting of outcomes by those caring for the neonates while ensuring accurate administration and monitoring by the healthcare providers.
入排标准
- 年龄范围
- 1 Day 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Neonates aged 1-28 days. Admitted to the neonatal intensive care unit (NICU) at Holy Family Hospital Rawalpindi.
- •Scheduled for surgery requiring maintenance fluid therapy postoperatively. Parental or guardian consent obtained.
排除标准
- •Neonates with pre-existing electrolyte imbalances or metabolic disorders. Neonates with congenital heart disease or renal impairment. Neonates on diuretics or other medications affecting fluid balance. Neonates with a history of intrauterine growth restriction (IUGR). Neonates with major congenital anomalies. Lack of parental or guardian consent.
研究组 & 干预措施
Isotonic Fluid Group
Neonates in this group will receive isotonic/normal saline with 5% dextrose in 0.9% saline as their maintenance fluid therapy post-surgery. This intervention aims to maintain serum sodium levels and reduce the risk of hyponatremia and other complications.
干预措施: Isotonic Saline with Dextrose (Drug)
Hypotonic Fluid Group
Neonates in this group will receive hypotonic saline with 5% dextrose in 0.45% saline as their maintenance fluid therapy post-surgery. This intervention is being compared to isotonic fluid therapy to evaluate its effectiveness and safety in maintaining electrolyte balance and preventing hypernatremia and edema.
干预措施: Isotonic Saline with Dextrose (Drug)
结局指标
主要结局
Incidence of Hyponatremia and Hypernatremia
时间窗: Before surgery (baseline measurement) 24 hours post-surgery
This outcome measures the incidence of hyponatremia (serum sodium level \<135 mEq/L) and hypernatremia (serum sodium level \>145 mEq/L) in neonates receiving either isotonic or hypotonic saline with dextrose as maintenance fluid therapy post-surgery
次要结局
- Incidence of Edema(Before surgery (baseline measurement) 24 hours post-surgery)
研究者
Mehak Fatima
Mehak Fatima
Rawalpindi Medical College