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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03054922

Enrollment

Registered

2017-02-16

Start date

2017-02-23

Completion date

2018-09-30

Last updated

2020-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Brief summary

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.

Interventions

DRUGNormal Saline

IV infusion of 0.9% NaCl throughout surgery.

DRUGLactated Ringer

IV infusion of lactated ringer throughout surgery.

DRUGNormosol-R Inj

IV infusion of Normosol throughout surgery.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 21 Years

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Participant flow

Participants by arm

Arm	Count
Normal Saline 0.9% Sodium Chloride Normal Saline: IV infusion of 0.9% NaCl throughout surgery.	20
Lactated Ringers 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 Lactated Ringer: IV infusion of lactated ringer throughout surgery.	19
Normosol-R 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. Normosol-R Inj: IV infusion of Normosol throughout surgery.	20
Total	59

Baseline characteristics

Characteristic	Total	Normal Saline	Normosol-R	Lactated Ringers
Age, Continuous	14 years STANDARD_DEVIATION 2	14 years STANDARD_DEVIATION 3	14 years STANDARD_DEVIATION 2	14 years STANDARD_DEVIATION 2
Race and Ethnicity Not Collected	0 Participants	—	—	—
Region of Enrollment United States	59 participants	20 participants	20 participants	19 participants
Sex: Female, Male Female	41 Participants	17 Participants	14 Participants	10 Participants
Sex: Female, Male Male	18 Participants	3 Participants	6 Participants	9 Participants
Weight	58 kilograms STANDARD_DEVIATION 17	61 kilograms STANDARD_DEVIATION 13	57 kilograms STANDARD_DEVIATION 18	57 kilograms STANDARD_DEVIATION 19

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 20	0 / 19	0 / 20
other Total, other adverse events	0 / 20	0 / 19	0 / 20
serious Total, serious adverse events	0 / 20	0 / 19	0 / 20