Intravenous fluid regimen and dyselectrolytemia among children.

Intravenous fluidregimen and dyselectrolytemia among children

Balaji Chinnasami, KanimozhiSadasivam, P. Sekar, Saravanan

Aim: The aimof this study is to compare the effect of three different intravenous (i.v.)fluid regimes I.e. Isolyte P, DNS and Plasma-Lyte 148 on the incidence ofdyselectrolytemia in hospitalized children ranging in age from 3 months to 12years.

Brief Introduction: The administration of intravenous (i.v.) maintenance fluid is anessential part of the management of sick children. In pediatric patients, theadministration of 0.18% saline in 5% dextrose as i.v. maintenance fluid is thecurrently accepted standard practice despite there being concerns regarding thepotential for hospital-acquired hyponatraemia associated with hypotonic i.v.fluid administration. In 2003, Moritz and Ayus introduced the concept of using0.9% saline as a maintenance parenteral fluid for the prevention of hospital-acquiredhyponatraemia in children. However excessive use of saline has been observed toresult in hyperchloremic acidosis. It has been suggested that the use ofbalanced solutions may avoid this effect. British Consensus Guidelines onIntravenous Fluid therapy for Adult Surgical Patients clearly recommend the useof balanced crystalloids rather than saline.

Study Design : It willbe a prospective study carried out on 150 children between 3mths to 12yrs ofage. The study will be conducted in department of pediatrics from August 2015to Janauary 2015. Children who require the administration of i.v. maintenancefluid for at least 24hrs following hospitalization will be eligible forinclusion. After obtaining consent from parents the children will be randomizedinto three i.v. fluid groups: Group A, 0.18% saline in 5% dextrose (Isolyte P);Group B, Plasma-Lyte 148; Group C, 0.9% saline in 5% dextrose. All three groupswill be receiving fluids at standard maintenance rate.

Inclusion Criteria : Childrenwho are judged by the treating physician to require i.v. maintenance fluidadministration for at least the following 24 h of their hospital stay will beeligible for inclusion in the study.

Exclusion Criteria : Childrenwith hyponatraemia (plasma sodium <130 mEq/L), hypernatraemia (plasma sodium>150 mEq/L) or hyperglycaemia (blood glucose>180 mg/dL), dehydration,shock, severe malnutrition, cirrhosis of liver, congestive heart failure, acuteor chronic renal failure and nephrotic syndrome will be excluded. Children whowere receiving drugs that alter plasma sodium levels, such as frusemide,hydrochlorothiazide, vasopressin or desmopressin and mannitol, will also beexcluded.

Sample Size : Giventhe sparse and conflicting data, we took the incidence of hospital-acquiredhyponatraemia among children to be 30%. Therefore, a sample of 72 patientswould be needed in each group to demonstrate a 10% decrease in the incidence ofhyponatraemia (defined as plasma sodium <130 mEq/L), with a power of 80% andalpha error of 0.05. In view of feasibility, it was decided a priori to enrollat least 50 patients in each treatment limb.

Outcome Measurement : Atenrolment, 2 mL of venous blood will be taken for estimation of plasma sodium,potassium, chloride, blood sugar, urea and creatinine. Plasma sodium,potassium, chloride, blood sugar levels will be estimated every day thereafter.The study measurements will be carried out until the child received only i.v.maintenance fluid therapy or at the 72-h time-point following the initiation ofthe i.v. fluid therapy, whichever is earlier.

Analysis of Data : Allanalyses will be performed on an intention to-treat basis. The outcomes in thethree groups will be compared. Proportions will be compared using Fisher’sexact test or the chi-square test. Continuous variables in the three studygroups will be compared using Kruskal–Wallis’ test.