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

NCT ID: NCT06484608

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-12-29

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Isotonic Saline with Dextrose

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Isotonic Saline with Dextrose

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Hypotonic Saline with Dextrose

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 30 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rawalpindi Medical College

OTHER

Sponsor Role: lead

Responsible Party

Mehak Fatima

Mehak Fatima

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehak Fatima, MBBS

Role: PRINCIPAL_INVESTIGATOR

RMU

Locations

Mehak Fatima

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

RawalpindiMU

Identifier Type: -

Identifier Source: org_study_id