Ignite Creation Date:
2024-07-17 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484608
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Brief Title:
Comparison of Isotonic Versus Hypotonic Fluids in Neonates for Maintenance Fluid Therapy After Surgery
Sponsor:
Rawalpindi Medical College
Organization:
Rawalpindi Medical College
Study Overview
Official Title:
Comparison of Isotonic Versus Hypotonic Fluids in Neonates Receiving Maintenance Fluid Therapy Post-Surgery A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 isotonicnormal saline with 5 dextrose in 09 saline to those receiving hypotonic fluids Group H hypotonic saline with 5 dextrose in 045 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 250
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 isotonicnormal saline with 5 dextrose in 09 saline to those receiving hypotonic fluids Group H hypotonic saline with 5 dextrose in 045 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 250
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 isotonicnormal saline with 5 dextrose in 09 saline Group H Received hypotonic saline with 5 dextrose in 045 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 mEqL and hypernatremia serum sodium level 145 mEqL Secondary outcomes included other complications such as edema
The results indicated that
Hyponatremia occurred in 2 48 cases in the isotonic group and 11 262 cases in the hypotonic group
Hypernatremia was observed in 9 214 cases in the isotonic group and none in the hypotonic group
Edema was noted in 1 24 neonate in the isotonic group and 9 214 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
Neonates were randomly assigned into two groups
Group I Received isotonicnormal saline with 5 dextrose in 09 saline Group H Received hypotonic saline with 5 dextrose in 045 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 mEqL and hypernatremia serum sodium level 145 mEqL Secondary outcomes included other complications such as edema
The results indicated that
Hyponatremia occurred in 2 48 cases in the isotonic group and 11 262 cases in the hypotonic group
Hypernatremia was observed in 9 214 cases in the isotonic group and none in the hypotonic group
Edema was noted in 1 24 neonate in the isotonic group and 9 214 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None