Variation in Natremia Using Two Different Maintenance Intravenous Fluids in Postsurgical Hospitalized Children

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this study is to compare the blood sodium level after 12 hours following the initiation of therapy with either 0.3% NaCl/dextrose 5% or 0.45% NaCl/dextrose 5%, in postsurgical hospitalized children requiring maintenance IV fluid administration.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children

NCT01301274

Hyponatremia

COMPLETED NA

0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Hospitalized Children

NCT00632775

Hyponatremia

COMPLETED PHASE3

Maintenance Intravenous Fluids in Children

NCT00621348

Hyponatremia

COMPLETED PHASE3

Intravenous Fluids in Hospitalised Children

NCT02926989

Hypokalemia Hyponatremia Hypernatremia +1 more

COMPLETED PHASE4

Reexamining Hypotonic Intravenous Fluid Use

NCT02667977

Hyponatremia

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Background: Despite prescription of maintenance IV fluids in hospitalized children is widely used since 1957 (Holiday \& Segar), it is not always adequate for children with acute diseases, leading to hyponatremia. This mainly occurs due to a non-physiologic ADH secretion in this group of patients due to nausea, stress, pain, and surgical interventions, and the use of hypotonic maintenance IV fluids.

0.3% NaCl/dextrose 5%, is widely use as IV maintenance fluid in children after surgery. There is evidence suggesting that these IV fluids used in postsurgical hospitalized patients do not provide the adequate amount of sodium they require, leading to an increased risk of developing hyponatremia. Using 0.45% NaCl/dextrose 5% as IV maintenance fluid in these children would prevent hyponatremia, but this treatment has not been totally studied yet.

Study procedures: Hospitalized children who fulfill inclusion criteria and not having any of the exclusion criteria will be considered for the enrolment after written informed consent.

Venous blood samples will be taken at enrollment (baseline) for estimation of serum sodium. After randomization, one group will receive 0.3% NaCl/dextrose 5%, IV, at standard maintenance rate (100 ml/kg for the first 10 kg of body weight, 50 ml/kg for the next 10 kg, and 20 ml/kg for body weight exceeding 20 kg). The second group will receive 0.45% NaCl/dextrose 5%, IV, at the same rate.

Serum sodium will be estimated in both groups after 12 hours of intravenous fluid therapy.

Children who required oral fluids will be excluded from per-protocol analysis, and only analyzed for intention to treat.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyponatremia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

half saline

Subjects in this arm will receive 0.45% NaCl/dextrose 5% intravenous (IV) maintenance fluids.

Group Type EXPERIMENTAL

0.45% NaCl/dextrose 5%

Intervention Type DRUG

Subjects in this arm will receive 0.45% NaCl/dextrose 5% intravenous (IV) maintenance fluids.Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m\^2 body surface.

third saline

Subjects in this arm will receive 0.3% NaCl/dextrose 5% intravenous (IV) maintenance fluids.

Group Type ACTIVE_COMPARATOR

0.3% NaCl/dextrose 5%

Intervention Type DRUG

Drug: 0.3% NaCl/dextrose 5% IV maintenance fluids. Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m\^2 surface.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

0.45% NaCl/dextrose 5%

Subjects in this arm will receive 0.45% NaCl/dextrose 5% intravenous (IV) maintenance fluids.Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m\^2 body surface.

Intervention Type DRUG

0.3% NaCl/dextrose 5%

Drug: 0.3% NaCl/dextrose 5% IV maintenance fluids. Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m\^2 surface.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

half saline third saline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Postsurgical children admitted to HGNPE Department of Surgery between january 2010 and october 2011.

Aged 1 month to 16 years. Initial plasma Na between 135-145 mmol/L. Primary route of fluid administration is anticipated to be intravenous, in the first 12 hours following surgery.

Informed consent of parent/guardian.

Exclusion Criteria

* • Children with illness that have primary fluid and electrolyte imbalance such as:

* Shock: Defined as acute circulatory failure resulting in decreased tissue perfusion and manifesting as altered sensorium, hypothermia (\<35oC), tachycardia, prolonged capillary filling time (\>3 seconds), hypotension (BP \< 5th percentile for age), oliguria (\<0.5 ml/kg/hr), hypoxemia, hyperlactatemia, requirement of fluid bolus and/ or vasopressors.
* Diarrhea and Dehydration: Children presenting with diarrhea and features of dehydration: lethargy, irritability and altered sensorium, thirst, decreased urine output, sunken eyes \& dry mucous membranes, loss of skin elasticity.; children with ongoing diarrhea will be excluded even if there is no dehydration.
* Fluid Overload: Cirrhosis, Congestive heart failure, Acute and Chronic renal failure, Nephrotic syndrome.

* Hyperglycemia: blood glucose \> 180 mg/ dl.
* Require ICU admission.
* Severe Protein Energy Malnutrition: Defined as grade III (50-59% of expected weight for age) and grade IV (less than 50% of expected weight for age) as per IAP classification.
* Patients in whom either hypotonic or isotonic solutions may be contraindicated/necessary: i.e. specific neurosurgical patients (ie those at risk of increased ICP, e.g. requiring actual brain surgery, ICP monitor or external ventricular drain insertion), patients with diabetic ketoacidosis, acute (≤ 7 days) burns, pre-existing CHF, liver failure or cirrhosis, renal failure.
* Patients with known pre-existing risk of PNa derangements: DI or SIADH

Minimum Eligible Age

1 Month

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No