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

NCT06484608 | Completed DMC

• 1 other identifier: RawalpindiMU
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyponatremia; Hypernatremia; Postoperative Care in Neonates; Edema

Keywords

isotonic saline, hypotonic saline, neonates, maintenance fluid therapy, surgery, hyponatremia

Outcome Measures

Primary Outcomes (1)

• Incidence of Hyponatremia and Hypernatremia

  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

  Before surgery (baseline measurement) 24 hours post-surgery

Secondary Outcomes (1)

• Incidence of Edema

  Before surgery (baseline measurement) 24 hours post-surgery

Study Arms (2)

Isotonic Fluid Group

EXPERIMENTAL

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.

Drug: Isotonic Saline with Dextrose

Hypotonic Fluid Group

ACTIVE COMPARATOR

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.

Drug: Isotonic Saline with Dextrose

Interventions

Isotonic Saline with Dextrose 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.

Also known as: Hypotonic Saline with Dextrose

Hypotonic Fluid Group; Isotonic Fluid Group

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rawalpindi Medical College: lead

Study Sites (1)

Mehak Fatima

Rawalpindi, Punjab Province, 00042, Pakistan

Location

MeSH Terms

Conditions

Hyponatremia; Hypernatremia; Edema

Interventions

Sodium Chloride; Glucose

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Mehak Fatima, MBBS

  RMU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mehak Fatima

Model Details: In this study, participants (neonates post-surgery) are randomly assigned to one of two groups, with each group receiving a different type of intervention (isotonic or hypotonic fluids). The parallel assignment model means that all participants in each group receive the same intervention throughout the study period, and the outcomes of these groups are compared to evaluate the effectiveness and safety of the interventions.

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: January 1, 2023
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)