Impact of Intraoperative Fluid Management on Electrolyte and Acid-base Variables

Study Overview
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Brief Summary
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During major surgical procedures, intravascular volume is maintained with the administration of isotonic fluids such as Lactated Ringers (LR), Normal Saline (NS) or Normosol-R. All three of these fluids are in common clinical use for this purpose. As large volumes of NS may result in a dilutional acidosis and an increasing base deficit, it may cloud clinical decision making when resuscitative efforts are guided by acid-base status on routine arterial blood gas analysis. This is a prospective, randomized study to evaluate changes in acid-base and electrolyte (sodium, potassium, calcium) status with the use of various isotonic fluids for intraoperative resuscitation.

Official Title
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Impact of Intraoperative Fluid Management on Electrolyte and Acid-base Variables

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Normal Saline
* Drug: Lactated Ringer
* Drug: Normosol-R Inj


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major surgical procedure requiring arterial access Exclusion Criteria: Comorbid disease process that contraindicates the use of any 1 of the 3 crystalloid solutions.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal Saline<br>0.9% Sodium Chloride | Drug: Normal Saline<br>* IV infusion of 0.9% NaCl throughout surgery.<br>* Other names: 0.9% NaCl;|
| Active Comparator: Lactated Ringers<br>Each 100 mL of Lactated Ringer's Injection USP contains: Sodium Chloride USP 0.6 g; Sodium Lactate USP 0.31 g; Potassium Chloride USP 0.03 g; Calcium Chloride Dihydrate USP 0.02 g; Water for Injection USP qs | Drug: Lactated Ringer<br>* IV infusion of lactated ringer throughout surgery.<br>|
| Active Comparator: Normosol-R<br>Each 100 mL of Normosol-R contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride hexahydrate, 30 mg. | Drug: Normosol-R Inj<br>* IV infusion of Normosol throughout surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Base Deficit | Change in base deficit from 1st to 2nd blood gas to measure metabolic acidosis | During surgery (typically 4-6 hrs in length) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sodium | Change in sodium electrolyte from 1st to 2nd blood gas | During surgery (typically 4-6 hrs in length) | 
| Change in Potassium | Change in potassium electrolyte from 1st to 2nd blood gas | During surgery (typically 4-6 hrs in length) | 
| Change in Ionized Calcium | Change in calcium electrolyte from 1st to 2nd blood gas | During surgery (typically 4-6 hrs in length) | 
| Change in pH | Change in pH from 1st to 2nd blood gas | During surgery (typically 4-6 hrs in length) |