NCT06484608

Comparison of Isotonic Versus Hypotonic Fluids in Neonates for Maintenance Fluid Therapy After Surgery

Comparison of Isotonic Versus Hypotonic Fluids in Neonates Receiving Maintenance Fluid Therapy Post-Surgery: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Rawalpindi Medical College · Academic / Other
• Sex: All
• Age: 1 Day – 30 Days
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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. Hypernatremia was observed in 9 (21.4%) cases in the isotonic group and none in the hypotonic group. Edema was noted in 1 (2.4%) neonate in the isotonic group and 9 (21.4%) neonates in the hypotonic group. The study concluded that isotonic saline is more effective in maintaining normal serum sodium levels and reducing the risk of hyponatremia and other complications compared to hypotonic saline in neonates post-surgery. Further research with larger sample sizes and additional electrolyte considerations is recommended to improve outcomes and reduce morbidity and mortality in this population.

Conditions

• Hyponatremia
• Hypernatremia
• Postoperative Care in Neonates
• Edema

Interventions

Type	Name	Description
DRUG	Isotonic Saline with Dextrose	This clinical trial involves two interventions for maintaining fluid therapy in neonates post-surgery. The first intervention, isotonic saline with dextrose, involves administering 0.9% saline solution combined with 5% dextrose. This isotonic solution aims to maintain serum sodium levels within the normal range and minimize the risk of hyponatremia and hypernatremia in postoperative neonates. The second intervention, hypotonic saline with dextrose, involves administering 0.45% saline solution combined with 5% dextrose. This hypotonic solution is being compared to the isotonic solution to evaluate its effectiveness in maintaining electrolyte balance.

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-12-29
• Completion: 2023-12-29
• First posted: 2024-07-03
• Last updated: 2024-07-03

Locations

1 site across 1 country: Pakistan