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Completed

NCT Number: NCT03054922

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

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.

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Key information

Conditions

Anesthesia

Age range

10 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

normal saline

Drug

IV infusion of 0.9% NaCl throughout surgery.

Other names: 0.9% NaCl

Lactated Ringer

Drug

IV infusion of lactated ringer throughout surgery.

Normosol-R Inj

Drug

IV infusion of Normosol throughout surgery.

Primary outcomes

  1. Change in Base Deficit

    Time frame: During surgery (typically 4-6 hrs in length)

    Change in base deficit from 1st to 2nd blood gas to measure metabolic acidosis

Secondary outcomes

  1. Change in Sodium

    Time frame: During surgery (typically 4-6 hrs in length)

    Change in sodium electrolyte from 1st to 2nd blood gas

  2. Change in Potassium

    Time frame: During surgery (typically 4-6 hrs in length)

    Change in potassium electrolyte from 1st to 2nd blood gas

  3. Change in Ionized Calcium

    Time frame: During surgery (typically 4-6 hrs in length)

    Change in calcium electrolyte from 1st to 2nd blood gas

  4. Change in pH

    Time frame: During surgery (typically 4-6 hrs in length)

    Change in pH from 1st to 2nd blood gas

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 16, 2017
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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