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

Nationwide Children's Hospital

Status and phase: Completed; Phase 3

Conditions: Anesthesia

Treatments: Drug: Normal Saline; Drug: Lactated Ringer; Drug: Normosol-R Inj

Study type: Interventional

Funder types: Other

Identifiers

NCT03054922

IRB16-01093

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 10 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 3 patient groups

Normal Saline

Active Comparator group

Description:

0.9% Sodium Chloride

Treatment:

Drug: Normal Saline

Lactated Ringers

Active Comparator group

Description:

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

Treatment:

Drug: Lactated Ringer

Normosol-R

Active Comparator group

Description:

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.

Treatment:

Drug: Normosol-R Inj