- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00621348
Maintenance Intravenous Fluids in Children
A RCT to Evaluate the Effect of Normal Saline in 5% Dextrose at Maintenance Rate, N/5 Saline in 5% Dextrose at 2/3 Maintenance Rate and N/5 Saline in 5% Dextrose at Maintenance Rate on Incidence of Hyponatremia in Hospitalized Children.
Hyponatraemia arises in between 20% and 45% of sick hospitalized children. An important reason for this high incidence could be use of hypotonic fluids in sick children for maintenance fluid therapy. There are no randomized controlled trials to evaluate the effect of various types of intravenous fluids on the incidence of hyponatremia in sick hospitalized children.
Hypothesis: Use of normal saline in 5% dextrose or reduced (2/3) volume of N/5 saline in 5% dextrose reduces incidence of hyponatremia (serum sodium 130 mmol/L) by two-thirds when compared to N/5 saline in 5% dextrose at standard maintenance rate in hospitalized children receiving intravenous maintenance fluids.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hyponatraemia arises in between 20% and 45% of sick hospitalized children. An important reason for this high incidence could be use of hypotonic fluids in sick children for maintenance fluid therapy. There are no randomized controlled trials to evaluate the effect of various types of intravenous fluids on the incidence of hyponatremia in sick hospitalized children. We therefore plan to conduct a randomized controlled trial to evaluate the effect of normal saline in 5% dextrose at standard maintenance rate, reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose and N/5 saline in 5% dextrose at standard maintenance rate on the incidence of hyponatremia in hospitalized children, aged 3 months- 12 years. To determine serial plasma vasopressin levels in hospitalized children at baseline, 24 hours and 48 hours of intravenous fluid therapy and compare the values in the three fluid regimens.
Study design: Randomized controlled trial. 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 for estimation of serum sodium, potassium, chloride, bicarbonate, blood gas, blood sugar, blood urea, serum creatinine, and plasma osmolality. A sample for estimation of plasma vasopressin will be collected at baseline. After randomization into three groups, one group of children will receive N/5 saline in 5% dextrose 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 of children will receive N/5 saline in 5% dextrose at 2/3 maintenance rate. The third group will receive dextrose normal saline at standard maintenance rate. Serum Na+, K+ and urine Na+, K+ will be estimated every 12 hourly till the patient is on intravenous fluid therapy and 12 hrs after stopping exclusive intravenous maintenance fluids. Serum and urine osmolality will be estimated every 24 hrs by an osmometer. Plasma vasopressin will be estimated in children in the 3 groups at 24, and 48 hours of intravenous fluid therapy.
Children will be weighed every 24 hours. The fluid balance, sodium balance, free water clearance will be calculated in a subset of children.
The study measurements will be carried out only till the time the child is on exclusive intravenous maintenance fluid therapy or 72 hrs of starting the intravenous fluid therapy. The decision to decrease/ stop intravenous fluid therapy will be left to the treating unit.
The primary outcome measure will be incidence of hyponatremia (defined as serum Na+ less than 130 mmol/L).
The secondary outcomes studied will be Plasma vasopressin levels at 24 hr and 48 hours and incidence of hypernatremia.
Sample size: Based on literature review, the incidence of hyponatremia with standard intravenous fluid therapy is approximately 30%. Sample of 72 patients will be needed in each group to demonstrate the decrease in incidence of hyponatremia to 10%, with a beta of 0.2 (Power 80%) and alpha error of 0.05.
Analysis: The data will be analyzed using STATA software. The outcomes (primary and secondary) in the 3 groups will be compared. For continuous variables, t test or Wilcoxon rank-sum test will be used to determine statistical significance. For categorical variables, chi square test will be used.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Delhi
-
New Delhi, Delhi, India, 110029
- All India Institute of Medical Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All children (3 months to 12 years) who are admitted to pediatric ward or pediatric ICU, who require exclusive intravenous maintenance fluid therapy for at least 24 hours will be eligible for the study
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.
Abnormal serum sodium or Hyperglycemia at Presentation:
- Hyponatremia : serum sodium < 130 mmol/L.
- Hypernatremia : serum sodium >150 mmol/L.
- Hyperglycemia: blood glucose > 180 mg/ dl.
- 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.
- Child who is receiving drugs which cause abnormality in serum sodium such as diuretics, vasopressin, etc.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Isotonic fluid group
Normal saline in 5% dextrose at standard maintenance rate
|
0.9% saline with 5% dextrose at standard maintenance rate
Other Names:
|
Active Comparator: Fluid restriction group
Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
|
Reduced volume (two thirds of standard maintenance rate) of N/5 saline in 5% dextrose
Other Names:
N/5 saline in 5% dextrose at standard maintenance rate
Other Names:
|
Active Comparator: Hypotonic fluid group
N/5 saline in 5% dextrose at standard maintenance rate
|
Reduced volume (two thirds of standard maintenance rate) of N/5 saline in 5% dextrose
Other Names:
N/5 saline in 5% dextrose at standard maintenance rate
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of Hyponatremia (Defined as Serum Sodium Less Than 130 mmol/L)
Time Frame: 72 hrs
|
72 hrs
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Hypernatremia (Serum Sodium >150 mmol/L)
Time Frame: 72 hrs
|
72 hrs
|
|
Incidence of Symptomatic Hyponatremia
Time Frame: 72 hrs
|
Defined as Hyponatremia (serum sodium < 130 mnol/L)and presence of symptoms attributed to hyponatremia such as altered sensorium, seizure, headache, and vomiting which can not be explained otherwise.
|
72 hrs
|
Incidence of Symptomatic Hypernatremia
Time Frame: 72 hrs
|
Symptomatic hypernatremia is defined as serum sodium > 150 mmol/L and the presence of symptoms like altered sensorium, seizure, headache and vomiting not explained otherwise.
|
72 hrs
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rakesh Lodha, MD, All India Institute of Medical Sciences, New Delhi
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RL-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hyponatremia
-
Otsuka Frankfurt Research Institute GmbHUnknownSIADH | Non-SIADH Hyponatremia | Non-HyponatremiaDenmark, Germany, Italy, Norway, Spain, Sweden, United Kingdom
-
Otsuka America PharmaceuticalRegistrat-MapiCompletedEuvolemic Hyponatremia | Hypervolemic HyponatremiaUnited States, United Kingdom, Germany
-
University Hospital, Basel, SwitzerlandNot yet recruitingThiazide Associated HyponatremiaSwitzerland
-
Korea Otsuka Pharmaceutical Co., Ltd.CompletedHypervolemic and Euvolemic HyponatremiaKorea, Republic of
-
Hospital Italiano de Buenos AiresSociedad Argentina de Hipertension Arterial (SAHA)CompletedThiazide Diuretics Induced HyponatremiaArgentina
-
CardioKine Inc.Biogen; Cardiokine Biopharma, LLCCompletedEuvolemic HyponatremiaUnited States, Israel, India, Mexico, Peru, Belgium, Czech Republic, Italy
-
CardioKine Inc.Biogen; Cardiokine Biopharma, LLCCompletedHyponatremia With Excess Extracellular Fluid Volume | Hyponatremia With Normal Extracellular Fluid VolumeUnited States
-
Jiangsu HengRui Medicine Co., Ltd.Beijing Friendship Hospital; Beijing 302 Hospital; Beijing Anzhen HospitalUnknownNon-hypovolemic Non-acute HyponatremiaChina
-
Western States Endurance Run Research FoundationUnknownExercise-associated HyponatremiaUnited States
-
University of CologneRecruitingNon-hypervolemic HyponatremiaGermany
Clinical Trials on Isotonic fluid
-
University Medicine GreifswaldCompletedPancreatic Cancer | Weight Loss | Biliary Tract Cancer
-
University of PittsburghTerminatedOrgan Transplantation From Brain-dead DonorsUnited States
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingAnhydramnios | Potter Syndrome | Lung Hypoplasia | Multicystic Dysplastic Kidney | Multicystic Renal Dysplasia, Bilateral | Lower Urinary Tract Obstructive Syndrome | Fetal Renal AnomalyUnited States
-
Baxter Healthcare CorporationHalozyme TherapeuticsWithdrawn
-
Nanyang Technological UniversityCompleted
-
Slagelse HospitalZealand University Hospital; Copenhagen University Hospital at Herlev; Holbaek... and other collaboratorsNot yet recruitingAsthma in Children | Bronchiolitis | Respiratory Disease | Acute Respiratory Infection | Viral Infection
-
Dokuz Eylul UniversityCukurova University; Kanuni Sultan Suleyman Training and Research Hospital; Baskent... and other collaboratorsCompletedFluid Therapy | Newborn Complication | Isotonic Dehydration | Hyponatremia of Newborn | Hypernatremia of Newborn | Sodium ChlorideTurkey
-
University Rovira i VirgiliHospital Universitari Sant Joan de ReusUnknownRehabilitation Post-meniscectomySpain
-
Hospital Universitario Ramon y CajalFondo de Investigacion SanitariaTerminated
-
Assiut UniversityCompleted