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

• Sponsor: Nationwide Children's Hospital
• Information provided by (Responsible Party): David P. Martin, Nationwide Children's Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anesthesia	Drug: Normal Saline; Drug: Lactated Ringer; Drug: Normosol-R Inj	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Impact of Intraoperative Fluid Management on Electrolyte and Acid-base Variables
Actual Study Start Date :	February 23, 2017
Actual Primary Completion Date :	September 30, 2018
Actual Study Completion Date :	September 30, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Normal Saline; 0.9% Sodium Chloride	Drug: Normal Saline; IV infusion of 0.9% NaCl throughout surgery.; Other Name: 0.9% NaCl
Active Comparator: 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	Drug: Lactated Ringer; IV infusion of lactated ringer throughout surgery.
Active Comparator: 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.	Drug: Normosol-R Inj; IV infusion of Normosol throughout surgery.

Outcome Measures

Primary Outcome Measures :

1. Base deficit [ Time Frame: End of surgery (typically 4-6 hrs after baseline or start of surgery) ]
   Obtained from blood gas to measure metabolic acidosis

Secondary Outcome Measures :

1. Sodium [ Time Frame: End of surgery (typically 4-6 hrs after baseline or start of surgery) ]
   Level of sodium electrolyte in blood
2. Potassium [ Time Frame: End of surgery (typically 4-6 hrs after baseline or start of surgery) ]
   Level of potassium electrolyte in blood
3. Ionized calcium [ Time Frame: End of surgery (typically 4-6 hrs after baseline or start of surgery) ]
   Level of calcium electrolyte in blood
4. Fluid requirement [ Time Frame: End of surgery (typically 4-6 hrs after baseline or start of surgery) ]
   Amount of fluid required for resuscitation during surgery
5. Urine output [ Time Frame: End of surgery (typically 4-6 hrs after baseline or start of surgery) ]
   Amount of urine produced during surgery

Eligibility Criteria

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Ages Eligible for Study:	10 Years to 21 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Locations

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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205

Sponsors and Collaborators

Nationwide Children's Hospital

More Information

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Responsible Party:	David P. Martin, Director, Acute Pain Services, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:	NCT03054922 History of Changes
Other Study ID Numbers:	IRB16-01093
First Posted:	February 16, 2017
Last Update Posted:	January 29, 2019
Last Verified:	January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No
Product Manufactured in and Exported from the U.S.:		No

Additional relevant MeSH terms:

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Plasma-lyte 148; Ophthalmic Solutions; Pharmaceutical Solutions