HyponatremiaNCT06484608
Comparison of Isotonic Versus Hypotonic Fluids in Neonates for Maintenance Fluid Therapy After Surgery
A study testing Isotonic Saline with Dextrose in people with Hyponatremia and Hypernatremia, run by Rawalpindi Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Hyponatremia, Hypernatremia, Postoperative Care in Neonates
- What is being tested?
- Isotonic Saline with Dextrose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2023to 29 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 30 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Isotonic Versus Hypotonic Fluids in Neonates Receiving Maintenance Fluid Therapy Post-Surgery: A Randomized Controlled Trial
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.
Read more
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.
Read the 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
- Being tested
- Isotonic Saline with Dextrose
- Keywords
- isotonic saline, hypotonic saline, neonates, maintenance fluid therapy, surgery, hyponatremia
- Medical subject headings
- Hyponatremia, Hypernatremia, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isotonic Saline with DextroseDrug
Also called Hypotonic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Isotonic Saline with Dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Before surgery (baseline measurement) 24 hours post-surgery
Secondary outcomes (1)
Incidence of Edema
This outcome measures the incidence of edema in neonates receiving either isotonic or hypotonic saline with dextrose as maintenance fluid therapy post-surgery
Measured: Before surgery (baseline measurement) 24 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jan 2023
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rawalpindi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehak Fatima, Rawalpindi Medical College
- Investigators
- Mehak Fatima, MBBS, Principal investigator, RMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484608
- Sponsor's protocol ID
- RawalpindiMU
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The plan for sharing individual participant data (IPD) is currently undecided. We recognize the importance of data sharing to advance scientific knowledge and improve clinical practices. We are considering several factors, including patient privacy, ethical considerations, and the logistics of data management, to make an informed decision. If a decision to share data is made in the future, we will outline the conditions under which the data will be shared, the type of data to be shared, and the means by which interested researchers can access the data. Any IPD sharing will be conducted in accordance with applicable regulations and ethical guidelines to ensure the protection of participant confidentiality and data integrity.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Isotonic Versus Hypotonic Fluids in Neonates Receiving Maintenance Fluid Therapy Post-Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06484608
- Acronym / sponsor ID
- RawalpindiMU
- Conditions
- Hyponatremia, Hypernatremia, Postoperative Care in Neonates, Edema
- Keywords
- isotonic saline, hypotonic saline, neonates, maintenance fluid therapy, surgery, hyponatremia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Rawalpindi Medical CollegeUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Isotonic Fluid Group | Experimental | Drug: Isotonic Saline with DextroseNeonates 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. |
| Hypotonic Fluid Group | Active comparator | Drug: Isotonic Saline with DextroseNeonates 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. |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isotonic Saline with DextroseAlso: Hypotonic Saline with DextroseThis 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. | Drug | Hypotonic Fluid Group, Isotonic Fluid Group |
Primary outcome
Incidence of Hyponatremia and Hypernatremia
Time frame: 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
1 secondary outcome
Incidence of Edema
Time frame: Before surgery (baseline measurement) 24 hours post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No. The plan for sharing individual participant data (IPD) is currently undecided. We recognize the importance of data sharing to advance scientific knowledge and improve clinical practices. We are considering several factors, including patient privacy, ethical considerations, and the logistics of data management, to make an informed decision. If a decision to share data is made in the future, we will outline the conditions under which the data will be shared, the type of data to be shared, and the means by which interested researchers can access the data. Any IPD sharing will be conducted in accordance with applicable regulations and ethical guidelines to ensure the protection of participant confidentiality and data integrity.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehak Fatima, MBBS principal investigator
RMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isotonic Saline with Dextrose in people with Hyponatremia and Hypernatremia, run by Rawalpindi Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Hyponatremia and Hypernatremia (time frame: Before surgery (baseline measurement) 24 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.